{"protocolSection":{"identificationModule":{"nctId":"NCT02443155","orgStudyIdInfo":{"id":"NN9828-4150"},"secondaryIdInfos":[{"id":"2014-001215-39","type":"EUDRACT_NUMBER"},{"id":"U1111-1154-7172","type":"OTHER","domain":"WHO"},{"id":"REec-2015-1768","type":"REGISTRY","domain":"Spanish registry"},{"id":"2014","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2014"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"A Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function","officialTitle":"A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Multi-centre Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function"},"statusModule":{"statusVerifiedDate":"2021-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2015-11-10","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2018-08-31","type":"ACTUAL"},"completionDateStruct":{"date":"2019-02-27","type":"ACTUAL"},"studyFirstSubmitDate":"2015-05-11","studyFirstSubmitQcDate":"2015-05-11","studyFirstPostDateStruct":{"date":"2015-05-13","type":"ESTIMATED"},"resultsFirstSubmitDate":"2020-12-11","resultsFirstSubmitQcDate":"2020-12-11","resultsFirstPostDateStruct":{"date":"2021-01-11","type":"ACTUAL"},"dispFirstSubmitDate":"2019-08-16","dispFirstSubmitQcDate":"2019-08-16","dispFirstPostDateStruct":{"date":"2019-08-19","type":"ACTUAL"},"lastUpdateSubmitDate":"2021-03-10","lastUpdatePostDateStruct":{"date":"2021-04-09","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This trial is conducted globally. The aim of this trial is to assess the clinical proof-of-principle of NNC0114-0006 and liraglutide on preservation of beta-cell function in adult subjects with newly diagnosed type 1 diabetes mellitus."},"conditionsModule":{"conditions":["Diabetes","Diabetes Mellitus, Type 1"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":308,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"NNC0114-0006 + Liraglutide","type":"EXPERIMENTAL","interventionNames":["Drug: NNC0114-0006","Drug: liraglutide"]},{"label":"NNC0114-0006 + Placebo","type":"EXPERIMENTAL","interventionNames":["Drug: NNC0114-0006","Drug: placebo"]},{"label":"Liraglutide + Placebo","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: liraglutide","Drug: placebo"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"NNC0114-0006","description":"NNC0114-0006 12 mg/kg administered i.v (intravenously) every 6 weeks. Subjects will continue their pre-trial insulin treatment","armGroupLabels":["NNC0114-0006 + Liraglutide","NNC0114-0006 + Placebo"]},{"type":"DRUG","name":"liraglutide","description":"Liraglutide 1.8 mg administered s.c. (subcutaneously) daily. Subjects will continue their pre-trial insulin treatment","armGroupLabels":["Liraglutide + Placebo","NNC0114-0006 + Liraglutide"]},{"type":"DRUG","name":"placebo","description":"Placebo administered s.c (subcutaneously) or i.v ( intravenously). Subjects will continue their pre-trial insulin treatment","armGroupLabels":["Liraglutide + Placebo","NNC0114-0006 + Placebo","Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 54 Relative to Baseline","description":"Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a mixed meal tolerance test (MMTT) stimulated C-peptide at week 54 is presented as ratio to baseline. AUC of C-peptide was measured as Nano moles\\*hour per liter (nmol\\*h/L).","timeFrame":"0 - 4 hours post-dose on week 0 and week 54"}],"secondaryOutcomes":[{"measure":"AUC0-2h of C-peptide at Week 54 Relative to Baseline","description":"Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated C-peptide at week 54 is presented as ratio to baseline. AUC of C-peptide was measured as 'nmol\\*h/L'.","timeFrame":"0-2 hours post-dose on week 0 and week 54"},{"measure":"Cmax of C-peptide at Week 54 Relative to Baseline","description":"Maximum observed concentration (Cmax) of a MMTT stimulated C-peptide at week 54 is presented as ratio to baseline. Cmax of C-peptide was measured as nanomoles per liter (nmol/L).","timeFrame":"0-4 hours post-dose on week 0 and week 54"},{"measure":"AUC0-4h of Glucose at Week 54 Relative to Baseline","description":"Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. AUC of glucose was measured as Milli moles\\*hour per liter (mmol\\*h/L).","timeFrame":"0 - 4 hours post-dose on week 0 and week 54"},{"measure":"AUC0-2h of Glucose at Week 54 Relative to Baseline","description":"Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. AUC of glucose is measured as 'mmol\\*h/L'.","timeFrame":"0-2 hours post-dose on week 0 and week 54"},{"measure":"Cmax of Glucose at Week 54 Relative to Baseline","description":"Maximum observed concentration (Cmax) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. Cmax of C-peptide was measured as 'mmol/L'.","timeFrame":"0-4 hours post-dose on week 0 and week 54"},{"measure":"Number of Treatment Emergent Adverse Events","description":"An adverse event was any untoward medical occurrence in a participants administered a product, and which did not necessarily have a causal relationship with this treatment. An adverse event was defined as treatment emergent if the onset of the adverse event occurs on or after the first day of trial product administration. Number of treatment emergent adverse events from first dose of trial product to week 54 and week 80 are presented. Results are based on the on-treatment and on-observation period.\n\nOn-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit.","timeFrame":"Week 0-54; Week 54-80"},{"measure":"Number of Treatment Emergent Hyperglycaemic Episodes","description":"Hyperglycaemic episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of treatment emergent episodes of hyperglycaemic episodes from first dose of trial product to week 54 and from week 54 to week 80 are presented. Results are based on the on-treatment and on-observation period.\n\nOn-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit.","timeFrame":"Week 0-54; Week 54-80"},{"measure":"Number of Treatment Emergent Episodes of Diabetic Ketoacidosis","description":"Diabetic ketoacidosis episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of treatment emergent episodes of hyperglycaemic episodes from first dose of trial product to week 54 and from week 54 to week 80 are presented. Results are based on the on-treatment and on-observation period.\n\nOn-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit.","timeFrame":"Weeks 0-54; Weeks 54-80"},{"measure":"Number of Participants Experiencing Treatment Emergent Injection/Infusion Site Reactions Caused by NNC0114-0006/Liraglutide/Placebo Injection/Infusion","description":"Injection/infusion site reactions episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of participants experiencing treatment emergent episodes of injection/infusion site reactions episodes from first dose of trial product to week 54 (treatment period) is presented.","timeFrame":"Week 0-54"},{"measure":"Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA)","description":"Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 1 day after the date of last contact. Number of treatment-emergent hypoglycaemic episodes according to American Diabetes Association (ADA) classification from first dose of trial product to week 54 and from week 54 to week 80 are presented.\n\nResults presented hypoglycaemia episodes were recorded as per ADA definition: Severe hypoglycaemia, Documented symptomatic hypoglycaemia, Asymptomatic hypoglycaemia, Probable symptomatic hypoglycaemia and Pseudo-hypoglycaemia.","timeFrame":"Weeks 0-54; Weeks 54-80"},{"measure":"Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions","description":"Hypoglycaemia episodes were recorded as per Novo Nordisk definition: Symptomatic BG-confirmed: An episode that is blood glucose (BG) confirmed by plasma glucose (PG) value \\<3.1 mmol/L with symptoms consistent with hypoglycaemia. Asymptomatic BG-confirmed: An episode that is BG-confirmed by PG value \\<3.1 mmol/L without symptoms consistent with hypoglycaemia. Severe or BG-confirmed symptomatic: An episode that is severe according to the ISPAD classification or BG-confirmed by a PG value \\<3.1 mmol/L with symptoms consistent with hypoglycaemia. BG-confirmed: An episode that is BG-confirmed by a PG value \\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Severe or BG-confirmed: An episode that is severe according to the International Society for Pediatric and Adolescent Diabetes (ISPAD) classification or BG-confirmed by a PG value \\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia.","timeFrame":"Weeks 0-54; Weeks 54-80"},{"measure":"Change in Body Weight (kg)","description":"Change in body weight is measured at week 54 and week 80 respective to baseline. Body weight was measured in unit 'Kg'.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Diabetes Retinopathy","description":"Number of participants evaluated for diabetic retinopathy at baseline (Day -28 to -14), week 54 and week 80 are presented as 'yes', 'no' or 'unknown'.","timeFrame":"Baseline, week 54 and week 80"},{"measure":"Estimated Glomerular Filtration Rate (eGFR)- Ratio to Baseline","description":"The eGFR was measured using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. Change in eGFR (measured in milliliters per minute per 1.73 square meters) from baseline (week 0) at week 54 and week 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Haematology: Erythrocytes","description":"Change in erythrocytes (measured in 10\\^12 cells per liter) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Haematology: Haematocrit","description":"Change in haematocrit (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Haematology: Haemoglobin","description":"Change in haemoglobin (measured in millimoles per liter 'mmol/L') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Haematology: Leukocytes","description":"Change in leukocytes (measured in 10\\^9 cells/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Haematology: Mean Corpuscular Hemoglobin","description":"Change in mean Corpuscular hemoglobin (measured in femtomole 'fmol') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Haematology: Mean Corpuscular Hemoglobin Concentration","description":"Change in mean corpuscular hemoglobin concentration (MCHC) (measured in gram per liter 'g/L') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Haematology: Mean Corpuscular Volume","description":"Change in Mean Corpuscular volume (measured in femtoliter 'fL') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Haematology: Thrombocytes","description":"Change in thrombocytes (measured in 10\\^9 cells per liter) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Haematology: Eosinophil","description":"Change in eosinophil (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Haematology: Neutrophils","description":"Change in neutrophils (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Haematology: Basophils","description":"Change in basophils (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Haematology: Lymphocytes","description":"Change in lymphocytes (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Haematology: Monocytes","description":"Change in monocytes (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Biochemistry: Alanine Aminotransferase (ALAT)","description":"Change in ALAT (measured in units per liter \\[U/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Biochemistry: Albumin","description":"Change in albumin (measured in gram per deciliter \\[g/dL\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Biochemistry: Amylase","description":"Change in amylase (measured in units per liter \\[U/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Biochemistry: Alkaline Phosphatase (ALP)","description":"Change in ALP (measured in units per liter \\[U/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Biochemistry: Aspartate Aminotransferase (ASAT)","description":"Change in ASAT (measured in units per liter \\[U/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Biochemistry: Total Bilirubin","description":"Change in Total bilirubin (measured in micromole per liter \\[umol/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Biochemistry: Calcium Corrected","description":"Change in calcium corrected (measured in millimole per liter \\[mmol/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Biochemistry: Chloride","description":"Change in chloride (measured in millimole per liter \\[mmol/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Biochemistry: Creatine Kinase","description":"Change in creatine kinase (measured in units per liter \\[U/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Biochemistry: Creatinine","description":"Change in creatinine (measured in micromole per liter \\[umol/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Biochemistry: Gamma-glutamyl Transferase (GGT)","description":"Change in GGT (measured in units per liter \\[U/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Biochemistry: C-reactive Protein Serum","description":"Change in C-reactive protein serum (measured in milligrams per liter \\[mg/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Biochemistry: Lactate Dehydrogenase","description":"Change in Lactate Dehydrogenase (measured in units per liter \\[U/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Biochemistry: Lipase","description":"Change in lipase (measured in units per liter \\[U/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Biochemistry: Magnesium","description":"Change in magnesium (measured in millimole per liter \\[mmol/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Biochemistry: Phosphate","description":"Change in phosphate (measured in millimole per liter \\[mmol/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Biochemistry: Potassium","description":"Change in potassium (measured in millimole per liter \\[mmol/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Biochemistry: Sodium","description":"Change in sodium (measured in millimole per liter \\[mmol/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Biochemistry: Total Protein","description":"Change in total protein (measured in gram per liter \\[g/dL\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Biochemistry: Blood Urea Nitrogen Serum","description":"Change in blood urea nitrogen serum (measured in milligram per deciliter \\[mg/dL\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Biochemistry: Uric Acid","description":"Change in Uric Acid (measured in milligram per deciliter \\[mg/dL\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in International Normalised Ratio (INR)","description":"Change in INR (measured in ratio\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in D-Dimer","description":"Change in D-Dimer (measured in mg/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Lipids: Total Cholesterol (Ratio to Baseline)","description":"Change in total cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Lipids: Free Fatty Acids (Ratio to Baseline)","description":"Change in total free fatty acids (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Lipids: HDL Cholesterol (Ratio to Baseline)","description":"Change in HDL cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Lipids: LDL Cholesterol (Ratio to Baseline)","description":"Change in LDL cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Lipids: Triglycerides (TG) (Ratio to Baseline)","description":"Change in Triglycerides (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Total Immunoglobulin E (IgE)","description":"Change in IgE (measured in kilo international units per liter \\[kIU/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Urinalysis: Urine Dipsticks","description":"Urinalysis was performed by urine dipsticks for protein, glucose, erythrocytes, ketones leukocytes, nitrite, pH and specific gravity and categorised as normal, abnormal not clinically significant (NCS) and abnormal clinially significant (CS). Number of participants in each category at baseline (week 0), week 54 and 80 are presented.","timeFrame":"Week 0, week 54 and week 80"},{"measure":"Change in Cytokines: Interleukin (IL)-6","description":"IL-6 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.","timeFrame":"Week 0, week 54 and week 80"},{"measure":"Change in Cytokines- Interleukin (IL)-10","description":"IL-10 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.","timeFrame":"Week 0, week 54 and week 80"},{"measure":"Change in Cytokines: Interleukin (IL)-17","description":"IL-17 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.","timeFrame":"Week 0, week 54 and week 80"},{"measure":"Change in Cytokines: Interferon (IFN) Gamma","description":"IFN gamma levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.","timeFrame":"Week 0, week 54 and week 80"},{"measure":"Change in Cytokines: TNF-alpha","description":"TNF-alpha levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.","timeFrame":"Week 0, week 54 and week 80"},{"measure":"Change in Hormone Level: Thyroid Stimulating Hormone (TSH)","description":"Change in TSH (measured in milli international units per liter \\[mIU/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Hormone Level: Calcitonin","description":"Change in Calcitonin (measured in nanogram per liter \\[ng/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Systolic and Diastolic Blood Pressure","description":"Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) are evaluated from baseline (week 0) to weeks 54 and 80.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Pulse","description":"Change in pulse is evaluated from baseline (week 0) to weeks 54 and 80","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Body Temperature","description":"Change in body temperature is evaluated from baseline (week 0) to weeks 54 and 80.","timeFrame":"Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Respiratory Rate","description":"Change in respiratory rate is evaluated from baseline (week 0) to weeks 54 and 80.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Electrocardiogram (ECG)","description":"The ECG was assessed by the investigator at baseline (week 0), week 54 and week 80 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline, week 54 and week 80 are presented.","timeFrame":"Week 0, week 54 and week 80"},{"measure":"Change in Eye-examination","description":"Dilated fundoscopy or fundus photography was performed by the investigator at week 0, week 54 and week 80. The results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at week 0, week 54 and week 80 are presented.","timeFrame":"Week 0, week 54 and week 80"},{"measure":"Change in Physical Examination","description":"Physical examination parameters are categorised as general appearance; head, ears, eyes, nose, throat, neck; respiratory system;cardiovascular system; gastrointestinal system including mouth; musculoskeletal system; central and peripheral nervous system; skin; lymph node palpation and thyroid gland. Investigator assessed the participants with normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) findings at week 0, week 54 and week 80 are presented.","timeFrame":"Week 0, week 54 and week 80"},{"measure":"Occurrence of Anti-NNC0114-0006 Antibodies","description":"This outcome measure was applicable for NNC0114-0006 + Liraglutide treatment arm and NNC0114-0006 treatment arm. Participants was assessed for anti-NNC0114-0006 antibodies. Participant who reported anti-NNC0114-0006 antibodies were further analyzed for cross-reactivity. Number of participants who measured with anti-NNC0114-0006 antibodies at week 54 and week 80 are presented.","timeFrame":"Week 0, week 54 and week 80"},{"measure":"Occurrence of Anti-liraglutide Antibodies","description":"This outcome measure is applicable for NNC0114-0006 + Liraglutide treatment arm and Liraglutide treatment arm. Participants was assessed for anti-liraglutide antibodies. Participant who reported anti-liraglutide antibodies were further analyzed for cross-reactivity. Number of participants who measured with anti-liraglutide antibodies at week 54 and week 80 are presented.","timeFrame":"Week 0, week 54 and week 80"},{"measure":"Change in Insulin Dose","description":"The total daily insulin dose was derived as the average of the doses reported on the three days prior to the visit. Change in daily total insulin dose from baseline (week 0) after 54 weeks of treatment and week 80 are presented.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Number of Insulin Injections","description":"The number of insulin injections was derived as the average of the reported number on the three days prior to the visit. The change in number of insulin injections per day (count) from baseline (week 0) after 54 weeks of treatment and week 80 are presented.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Number of Weeks Off Bolus Insulin","description":"The number of weeks off bolus insulin after 54 weeks of treatment and week 80 are presented.","timeFrame":"(Week 0 to week 54) and (week 0 to week 80)"},{"measure":"Change in HbA1c","description":"Change in glycosylated haemoglobin (HbA1c) is evaluated from baseline (week 0) to weeks 54 and 80.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Fasting Plasma Glucose","description":"Change in fasting plasma glucose is evaluated from baseline (week 0) to weeks 54 and 80.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Fasting C-peptide- Ratio to Baseline","description":"Change in fasting C-peptide (measured in nanomole per liter \\[nmol/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Fasting Glucagon- Ratio to Baseline","description":"Change in fasting glucagon (measured in picogram per milliliter \\[pg/mL\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"7-point SMPG Profiles","description":"Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. 7-point SMPG profile values are presented for week 54 and week 80.","timeFrame":"Week 54 and Week 80"},{"measure":"Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner","description":"Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Change from baseline (week 0) to week 54 and week 80 in 7-point SMPG postprandial glucose /prandial increment (breakfast, lunch and dinner) value are presented.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment (Average Over the Three Meals)","description":"Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. Change from baseline (week 0) to week 54 and week 80 in 7-point self-measured plasma glucose (SMPG) postprandial glucose /prandial increment (average over the three meals) value is presented.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Mean of 7-point Profiles","description":"Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. Change from baseline (week 0) to week 54 and week 80 in mean of 7-point profiles value is presented.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Before Breakfast 7- Points Self Measured Plasma Glucose (SMPG)","description":"Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Before breakfast 7-point self-measured plasma glucose (SMPG) profile values are presented at week 54 and week 80.","timeFrame":"Week 54 and week 80"},{"measure":"Area Under the NNC0114-0006 Concentration-time Curve Over a Dosing Interval at Steady State (AUCtau, NNC0114-0006)","description":"AUCtau, NNC0114-0006 was derived as the area under the concentration-time curve using the linear trapezoidal technique based on observed values and actual measurement times between 0 and 6 weeks (after the last dose). This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.","timeFrame":"Pre-dose and 1 hour post-dose during week 48 to week 54"},{"measure":"Terminal Half-life (t½) After Last Dose of NNC0114-0006","description":"Terminal half life was calculated as log(2)/λz. The terminal rate constant λz was determined through linear regression with the logarithm to concentration as the response variable and actual measurement time as the explanatory variable. Valid observations from the terminal part of the curve, which is approximately linear, were used for the determination. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.","timeFrame":"Pre-dose and 1 hour post-dose during week 48 to week 80"},{"measure":"Apparent Volume of Distribution of NNC0114-0006 at Steadystate (Vss, NNC0114-0006)","description":"The apparent volume of distribution of NNC0114-0006 at steady-state was calculated as mean residence time of (MRT) of NNC0114-0006 multiplied by clearance of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.","timeFrame":"Pre-dose and 1 hour post-dose during week 48 to week 80"},{"measure":"Clearance of NNC0114-0006 at Steady State (CLss, NNC0114-0006)","description":"Clearance of NNC0114-0006 at steady state was calculated as dose/AUCtau, NNC0114-0006. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.","timeFrame":"Pre-dose and 1 hour post-dose during week 48 to week 54"},{"measure":"Mean Residence Time of NNC0114-0006 (MRT, NNC0114-0006)","description":"This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms. Mean residence time of NNC0114-0006 is presented.","timeFrame":"Pre-dose and 1 hour post-dose during week 48 to week 80"},{"measure":"Accumulation Ratio of NNC114-0006 (RA,AUC, NNC0114-0006)","description":"Accumulation ratio of NNC114-0006 was defined as AUC48-54 weeks/AUC0-6 weeks. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.","timeFrame":"Pre-dose and 1 hour post-dose during (week 0 to week 6) and (week 48 to week 54)"},{"measure":"Observed NNC0114-0006 Concentration Prior to Dosing of NNC0114-0006 at Steady State (Ctrough, NNC0114-0006)","description":"Ctrough of NNC0114-0006 was defined as concentration prior to dosing of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.","timeFrame":"Week 48 (predose)"},{"measure":"Observed NNC0114-0006 Concentration 1 Hour After Dosing of NNC0114-0006 at Steady State (C1h, NNC0114-0006)","description":"C1h, NNC0114-0006 was defined as concentration of NNC0114-0006 at 1 hour after dosing of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.","timeFrame":"Week 48 (1 hour post-dose)"},{"measure":"Liraglutide Concentration at Steady State (C Liraglutide)","description":"C liraglutide was defined as the liraglutide concentration at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and Liraglutide treatment arms.","timeFrame":"Week 54 (post-dose)"},{"measure":"Change in Biomarker: Immune Phenotyping- B Cell Panel","description":"B cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80.\n\nIn below table CD refer to Cluster of Differentiation; IgMNeg refers to Immunoglobulin M negative; IgDNeg refers to Immunoglobulin D negative.","timeFrame":"Week 0, week 54 and week 80"},{"measure":"Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel","description":"NK cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80.\n\nIn below table ADCC refer to Antibody-dependent cellular cytotoxicity; CD refer to Cluster of Differentiation.","timeFrame":"Week 0, week 54 and week 80"},{"measure":"Change in Biomarker: Immune Phenotyping- T Cell Panel","description":"T cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80.\n\nIn below table CD refer to Cluster of Differentiation; TEMRA refers to terminally differentiated effector memory cells re-expressing CD45RA; CCR refers to C-C chemokine receptor; TREG refers to Regulatory T cells.","timeFrame":"Week 0, week 54 and week 80"},{"measure":"Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel","description":"TfH cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80.\n\nIn below table CTFH refer to Circulating T follicular helper; ICOS refers to inducible T-cell co-stimulator; PD refers to Programmed cell death protein; CCR refers to C-C chemokine receptor; CXCR refers to C-X-C chemokine receptor; CD refer to Cluster of Differentiation; CM refers to central memory; EM refers to effector memory, TIGIT refers to T cell immunoreceptor with Ig and ITIM domains.","timeFrame":"Week 0, week 54 and week 80"},{"measure":"Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel","description":"Myeloid panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80.\n\nIn below table HLA refers to Human Leukocyte Antigen; MDSC refers to myeloid-derived suppressor cell; DC refers to Dendritic cells; MYDC refers to Myeloid Dendritic Cells; IMMYE\\_MDSC refers to Immature myeloid cells \\& a subset of myeloid suppressor cells within the CD14-HLA class II- myeloid cell population.","timeFrame":"Week 0, week 54 and week 80"},{"measure":"Autoantibodies Against Glutamic Acid Decarboxylase (GAD)","description":"Participants were analyzed for autoantibodies against Glutamic acid decarboxylase (GAD) and were categorized as negative and positive.","timeFrame":"Week 0, week 54 and week 80"},{"measure":"Autoantibodies Against Zinc-transporter 8 (ZnT8)","description":"Participants were analyzed for autoantibodies against Zinc-transporter 8 (ZnT8) and were categorized as negative and positive.","timeFrame":"Week 0, week 54 and week 80"},{"measure":"Autoantibodies Against Islet Antigen-2 (IA2)","description":"Participants were analyzed for autoantibodies against Islet antigen-2 (IA2) and were categorized as negative and positive.","timeFrame":"Week 0, week 54 and week 80"},{"measure":"Autoantibodies Against Insulin Autoantibodies (IAA)","description":"Participants were analyzed for autoantibodies against Insulin autoantibodies (IAA) and were categorized as negative and positive.","timeFrame":"Week 0, week 54 and week 80"},{"measure":"Change in Biomarker: Total Interleukin-21 (IL-21)","description":"IL-21 is evaluated at baseline (week 0), week 54 and week 80.","timeFrame":"Week 0, week 54 and week 80"},{"measure":"Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol)","description":"Serum vitamin D is evaluated at baseline (week 0), week 54 and week 80.","timeFrame":"Week 0, week 54 and week 80"},{"measure":"Change in Short Form 36 Health Survey (SF-36)","description":"SF-36v2™ questionnaire measured the HRQoL on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. Change from baseline (week 0) to week 54 and week 80 in SF-36 score is presented.The MCS measure is derived from domain scales of vitality, social functioning, role emotional and mental health. The PCS measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicate an improvement since baseline.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Experience of Treatment Benefits and Barriers (ETBB)","description":"Treatment Benefits and Barriers (ETBB) questionnaire measured diabetes-specific health beliefs on 2 categories: Total Score for Perceived Barriers and Perceived Benefits. The measurement of perceived benefits of, and barriers to, treatment was achieved by creating a pool 28 statements each with a 7-point scale ranging from strongly agree (6) to strongly disagree (0). ETBB benefits score was calculated using the responses from questions 1, 4, 7, 8, 10, and 12 and ETBB barriers score was calculated using the responses from questions 2, 3, 5, 6, 9, and 11. Both was calculated as the sum of responses divided by number of responses received multiplied by the maximum number of responses. Based on the responses used the maximum responses available was 6. The higher score indicates more perceived benefits or more perceived barrier.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ)","description":"Change from baseline (week 0) in DTSQ is evaluated at week 54 and 80. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher score indicates a higher level of glycaemia/treatment satisfaction.","timeFrame":"(Week 0, week 54) and (week 0, week 80)"},{"measure":"Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 80 Relative to Baseline","description":"Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a mixed meal tolerance test (MMTT) stimulated C-peptide at week 80 is presented as ratio to baseline. AUC of C-peptide was measured as Nano moles\\*hour per liter (nmol\\*h/L).","timeFrame":"0 - 4 hours post-dose on week 0 and week 80"},{"measure":"AUC0-2h of C-peptide at Week 80 Relative to Baseline","description":"Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated C-peptide at week 80 is presented as ratio to baseline. AUC of C-peptide was measured as 'nmol\\*h/L'.","timeFrame":"0-2 hours post-dose on week 0 and week 80"},{"measure":"Cmax of C-peptide at Week 80 Relative to Baseline","description":"Maximum observed concentration (Cmax) of a MMTT stimulated C-peptide at week 80 is presented as ratio to baseline. Cmax of C-peptide was measured as nanomoles per liter (nmol/L).","timeFrame":"0-4 hours post-dose on week 0 and week 80"},{"measure":"AUC0-4h of Glucose at Week 80 Relative to Baseline","description":"Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. AUC of glucose was measured as Milli moles\\*hour per liter (mmol\\*h/L).","timeFrame":"0 - 4 hours post-dose on week 0 and week 80"},{"measure":"AUC0-2h of Glucose at Week 80 Relative to Baseline","description":"Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. AUC of glucose was measured as 'mmol\\*h/L'.","timeFrame":"0-2 hours post-dose on week 0 and week 80"},{"measure":"Cmax of Glucose at Week 80 Relative to Baseline","description":"Maximum observed concentration (Cmax) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. Cmax of C-peptide was measured as 'mmol/L'.","timeFrame":"0-4 hours post-dose on week 0 and week 80"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial\n* T1DM (type 1 diabetes mellitus) (as diagnosed clinically) for not more than 20 weeks prior to screening - Male or female, aged 18-45 (both inclusive) at the time of signing the informed consent form\n* Non-fasting peak C-peptide higher or equal to 0.2 nmol/l at visit 2\n* BMI (body mass index) higher or equal to 18.5 kg/m\\^2\n* Presence of one or more islet specific auto antibodies (glutamic acid decarboxylase (GAD), islet antigen-2 (IA2) or zinc-transporter 8 (ZnT8)) at screening\n* Insulin dependence unless in temporary spontaneous remission (honeymoon period)\n\nExclusion Criteria:\n\n* Daily insulin usage above 1 U/kg per day at screening or use of continuous subcutaneous insulin infusion (CSII)\n* History of recurrent (e.g. several times a year) of severe (e.g. pneumonia) or chronic infections or conditions predisposing to chronic infections (e.g., bronchiectasis and chronic osteomyelitis)\n* History of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate documented therapy\n* Vaccination within 4 weeks before randomisation, Visit 3 (V3)\n* Receipt of any other concomitant medications or herbal products that can influence the immune system within 90 days prior to screening (V1)\n* History of pancreatitis (acute or chronic)\n* Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)\n* Any past or current diagnosis of malignant neoplasms\n* Known impairment of the immune system, except for T1DM, coeliac disease, alopecia, autoimmune antibodies not considered clinical important (e.g. thyroid antibodies without any clinically important thyroid disease), and vitiligo","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"45 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Global Clinical Registry (GCR, 1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Novo Nordisk Investigational Site","city":"La Jolla","state":"California","zip":"92037","country":"United States","geoPoint":{"lat":32.84727,"lon":-117.2742}},{"facility":"Novo Nordisk Investigational Site","city":"Northridge","state":"California","zip":"91325","country":"United States","geoPoint":{"lat":34.22834,"lon":-118.53675}},{"facility":"Novo Nordisk Investigational Site","city":"Aurora","state":"Colorado","zip":"80045","country":"United States","geoPoint":{"lat":39.72943,"lon":-104.83192}},{"facility":"Novo Nordisk Investigational Site","city":"Miami","state":"Florida","zip":"33136","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"Novo Nordisk Investigational Site","city":"Orlando","state":"Florida","zip":"32804","country":"United 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contributors. Anti-interleukin-21 antibody and liraglutide for the preservation of beta-cell function in adults with recent-onset type 1 diabetes: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Diabetes Endocrinol. 2021 Apr;9(4):212-224. doi: 10.1016/S2213-8587(21)00019-X. Epub 2021 Mar 1."}],"seeAlsoLinks":[{"label":"Clinical Trials at Novo Nordisk","url":"http://novonordisk-trials.com"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants were randomised in a 1:1:1:1 manner to one of the four treatment groups. One participant was randomised to liraglutide arm but was withdrawn from the trial before exposure to trial products as per investigator's decision.","recruitmentDetails":"The trial was conducted at 94 sites in Austria, Belgium, Canada, Denmark, Finland, Ireland, Israel, Italy, Norway, Poland, Portugal, Russian Federation, Spain, Sweden, Ukraine, the United Kingdom (UK), and the United States (US).","groups":[{"id":"FG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"FG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"FG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"FG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"77"},{"groupId":"FG001","numSubjects":"77"},{"groupId":"FG002","numSubjects":"76"},{"groupId":"FG003","numSubjects":"77"}]},{"type":"Full Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"77"},{"groupId":"FG001","numSubjects":"77"},{"groupId":"FG002","numSubjects":"76"},{"groupId":"FG003","numSubjects":"77"}]},{"type":"PK Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"21"},{"groupId":"FG002","numSubjects":"22"},{"groupId":"FG003","numSubjects":"20"}]},{"type":"Safety Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"77"},{"groupId":"FG001","numSubjects":"77"},{"groupId":"FG002","numSubjects":"76"},{"groupId":"FG003","numSubjects":"77"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"65"},{"groupId":"FG001","numSubjects":"63"},{"groupId":"FG002","numSubjects":"67"},{"groupId":"FG003","numSubjects":"61"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"9"},{"groupId":"FG003","numSubjects":"16"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"2"}]},{"type":"Unclassified","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"9"}]},{"type":"Pregnancy","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"2"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"The Full analysis set (FAS) included all randomised participants.","groups":[{"id":"BG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"BG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"BG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"BG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"77"},{"groupId":"BG001","value":"77"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"77"},{"groupId":"BG004","value":"307"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"28.0","spread":"7.5"},{"groupId":"BG001","value":"28.6","spread":"7.9"},{"groupId":"BG002","value":"28.0","spread":"7.1"},{"groupId":"BG003","value":"29.0","spread":"7.0"},{"groupId":"BG004","value":"28.4","spread":"7.3"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"28"},{"groupId":"BG004","value":"106"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"56"},{"groupId":"BG001","value":"45"},{"groupId":"BG002","value":"51"},{"groupId":"BG003","value":"49"},{"groupId":"BG004","value":"201"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"10"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"73"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"74"},{"groupId":"BG003","value":"76"},{"groupId":"BG004","value":"297"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"1"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"4"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"73"},{"groupId":"BG001","value":"70"},{"groupId":"BG002","value":"73"},{"groupId":"BG003","value":"76"},{"groupId":"BG004","value":"292"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"10"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 54 Relative to Baseline","description":"Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a mixed meal tolerance test (MMTT) stimulated C-peptide at week 54 is presented as ratio to baseline. AUC of C-peptide was measured as Nano moles\\*hour per liter (nmol\\*h/L).","populationDescription":"The FAS included all randomised participants. Overall number of participants analysed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of AUC","timeFrame":"0 - 4 hours post-dose on week 0 and week 54","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"63"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.934","spread":"61.9"},{"groupId":"OG001","value":"0.783","spread":"45.5"},{"groupId":"OG002","value":"0.709","spread":"104.8"},{"groupId":"OG003","value":"0.660","spread":"86.3"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"groupDescription":"Ratio of week 54 to baseline are analysed using mixed model for repeated measurements (MMRM) with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.","nonInferiorityType":"SUPERIORITY","pValue":"=0.0017","statisticalMethod":"Mixed model repeated measurements","paramType":"Treatment ratio","paramValue":"1.48","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.16","ciUpperLimit":"1.89","estimateComment":"NNC0114-0006 + liraglutide / Placebo"},{"groupIds":["OG001","OG003"],"groupDescription":"Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.","nonInferiorityType":"SUPERIORITY","pValue":"=0.0927","statisticalMethod":"Mixed model repeated measurements","paramType":"Treatment Ratio","paramValue":"1.23","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.97","ciUpperLimit":"1.57"},{"groupIds":["OG002","OG003"],"groupDescription":"Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.","nonInferiorityType":"SUPERIORITY","pValue":"=0.3780","statisticalMethod":"Mixed model repeated measurements","paramType":"Treatment Ratio","paramValue":"1.12","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.87","ciUpperLimit":"1.42"},{"groupIds":["OG000","OG001"],"groupDescription":"Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.","nonInferiorityType":"SUPERIORITY","pValue":"=0.1377","statisticalMethod":"Mixed model repeated measurements","paramType":"Treatment ratio","paramValue":"1.20","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.94","ciUpperLimit":"1.53"},{"groupIds":["OG000","OG002"],"groupDescription":"Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.","nonInferiorityType":"SUPERIORITY","pValue":"=0.0214","statisticalMethod":"Mixed model repeated measurements","paramType":"Treatment ratio","paramValue":"1.33","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.04","ciUpperLimit":"1.69"},{"groupIds":["OG001","OG002"],"groupDescription":"Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.","nonInferiorityType":"SUPERIORITY","pValue":"=0.4187","statisticalMethod":"Mixed model repeated measurements","paramType":"Treatmrnt ratio","paramValue":"1.10","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.87","ciUpperLimit":"1.41"}]},{"type":"SECONDARY","title":"AUC0-2h of C-peptide at Week 54 Relative to Baseline","description":"Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated C-peptide at week 54 is presented as ratio to baseline. AUC of C-peptide was measured as 'nmol\\*h/L'.","populationDescription":"The FAS included all randomised participants. 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Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"63"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.961","spread":"65.4"},{"groupId":"OG001","value":"0.824","spread":"53.0"},{"groupId":"OG002","value":"0.646","spread":"97.4"},{"groupId":"OG003","value":"0.655","spread":"87.3"}]}]}]},{"type":"SECONDARY","title":"Cmax of C-peptide at Week 54 Relative to Baseline","description":"Maximum observed concentration (Cmax) of a MMTT stimulated C-peptide at week 54 is presented as ratio to baseline. Cmax of C-peptide was measured as nanomoles per liter (nmol/L).","populationDescription":"The FAS included all randomised participants. Overall number of participants analysed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of Cmax","timeFrame":"0-4 hours post-dose on week 0 and week 54","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"63"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.978","spread":"70.3"},{"groupId":"OG001","value":"0.779","spread":"47.6"},{"groupId":"OG002","value":"0.733","spread":"110.4"},{"groupId":"OG003","value":"0.644","spread":"89.4"}]}]}]},{"type":"SECONDARY","title":"AUC0-4h of Glucose at Week 54 Relative to Baseline","description":"Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. AUC of glucose was measured as Milli moles\\*hour per liter (mmol\\*h/L).","populationDescription":"The FAS included all randomised participants. Overall number of participants analysed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of AUC","timeFrame":"0 - 4 hours post-dose on week 0 and week 54","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"62"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.904","spread":"33.1"},{"groupId":"OG001","value":"1.078","spread":"31.8"},{"groupId":"OG002","value":"0.993","spread":"34.2"},{"groupId":"OG003","value":"1.089","spread":"36.7"}]}]}]},{"type":"SECONDARY","title":"AUC0-2h of Glucose at Week 54 Relative to Baseline","description":"Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. AUC of glucose is measured as 'mmol\\*h/L'.","populationDescription":"The FAS included all randomised participants. Overall number of participants analysed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of AUC","timeFrame":"0-2 hours post-dose on week 0 and week 54","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"62"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.939","spread":"28.5"},{"groupId":"OG001","value":"1.066","spread":"24.8"},{"groupId":"OG002","value":"0.978","spread":"31.9"},{"groupId":"OG003","value":"1.057","spread":"31.3"}]}]}]},{"type":"SECONDARY","title":"Cmax of Glucose at Week 54 Relative to Baseline","description":"Maximum observed concentration (Cmax) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. Cmax of C-peptide was measured as 'mmol/L'.","populationDescription":"The FAS included all randomised participants. Overall number of participants analysed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of Cmax","timeFrame":"0-4 hours post-dose on week 0 and week 54","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"62"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.937","spread":"27.8"},{"groupId":"OG001","value":"1.068","spread":"25.4"},{"groupId":"OG002","value":"1.004","spread":"29.1"},{"groupId":"OG003","value":"1.057","spread":"30.9"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment Emergent Adverse Events","description":"An adverse event was any untoward medical occurrence in a participants administered a product, and which did not necessarily have a causal relationship with this treatment. An adverse event was defined as treatment emergent if the onset of the adverse event occurs on or after the first day of trial product administration. Number of treatment emergent adverse events from first dose of trial product to week 54 and week 80 are presented. Results are based on the on-treatment and on-observation period.\n\nOn-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Adverse events","timeFrame":"Week 0-54; Week 54-80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Week 0-54","categories":[{"measurements":[{"groupId":"OG000","value":"434"},{"groupId":"OG001","value":"327"},{"groupId":"OG002","value":"410"},{"groupId":"OG003","value":"364"}]}]},{"title":"Week 54-80","categories":[{"measurements":[{"groupId":"OG000","value":"70"},{"groupId":"OG001","value":"73"},{"groupId":"OG002","value":"78"},{"groupId":"OG003","value":"87"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment Emergent Hyperglycaemic Episodes","description":"Hyperglycaemic episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of treatment emergent episodes of hyperglycaemic episodes from first dose of trial product to week 54 and from week 54 to week 80 are presented. Results are based on the on-treatment and on-observation period.\n\nOn-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"Week 0-54; Week 54-80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Week 0-54","categories":[{"measurements":[{"groupId":"OG000","value":"302"},{"groupId":"OG001","value":"256"},{"groupId":"OG002","value":"217"},{"groupId":"OG003","value":"291"}]}]},{"title":"Week 54-80","categories":[{"measurements":[{"groupId":"OG000","value":"306"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"352"},{"groupId":"OG003","value":"112"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment Emergent Episodes of Diabetic Ketoacidosis","description":"Diabetic ketoacidosis episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of treatment emergent episodes of hyperglycaemic episodes from first dose of trial product to week 54 and from week 54 to week 80 are presented. Results are based on the on-treatment and on-observation period.\n\nOn-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"Weeks 0-54; Weeks 54-80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Week 0-54","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Week 54-80","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Experiencing Treatment Emergent Injection/Infusion Site Reactions Caused by NNC0114-0006/Liraglutide/Placebo Injection/Infusion","description":"Injection/infusion site reactions episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of participants experiencing treatment emergent episodes of injection/infusion site reactions episodes from first dose of trial product to week 54 (treatment period) is presented.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 0-54","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA)","description":"Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 1 day after the date of last contact. Number of treatment-emergent hypoglycaemic episodes according to American Diabetes Association (ADA) classification from first dose of trial product to week 54 and from week 54 to week 80 are presented.\n\nResults presented hypoglycaemia episodes were recorded as per ADA definition: Severe hypoglycaemia, Documented symptomatic hypoglycaemia, Asymptomatic hypoglycaemia, Probable symptomatic hypoglycaemia and Pseudo-hypoglycaemia.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"Weeks 0-54; Weeks 54-80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Severe hypoglycaemia (Week 0-54)","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Asymptomatic hypoglycaemia (Week 0-54)","categories":[{"measurements":[{"groupId":"OG000","value":"2038"},{"groupId":"OG001","value":"1956"},{"groupId":"OG002","value":"2092"},{"groupId":"OG003","value":"1774"}]}]},{"title":"Documented symptomatic hypoglycaemia (Week 0-54)","categories":[{"measurements":[{"groupId":"OG000","value":"1305"},{"groupId":"OG001","value":"1461"},{"groupId":"OG002","value":"1114"},{"groupId":"OG003","value":"1625"}]}]},{"title":"Pseudo-hypoglycaemia (Week 0-54)","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"14"},{"groupId":"OG003","value":"2"}]}]},{"title":"Probable symptomatic hypoglycaemia (Week 0-54)","categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"10"}]}]},{"title":"Severe hypoglycaemia (Week 54-80)","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}]},{"title":"Asymptomatic hypoglycaemia (Week 54-80)","categories":[{"measurements":[{"groupId":"OG000","value":"609"},{"groupId":"OG001","value":"522"},{"groupId":"OG002","value":"670"},{"groupId":"OG003","value":"449"}]}]},{"title":"Documented symptomatic hypoglycaemia (Week 54-80)","categories":[{"measurements":[{"groupId":"OG000","value":"514"},{"groupId":"OG001","value":"362"},{"groupId":"OG002","value":"651"},{"groupId":"OG003","value":"527"}]}]},{"title":"Pseudo-hypoglycaemia (Week 54-80)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"2"}]}]},{"title":"Probable symptomatic hypoglycaemia (Week 54-80)","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions","description":"Hypoglycaemia episodes were recorded as per Novo Nordisk definition: Symptomatic BG-confirmed: An episode that is blood glucose (BG) confirmed by plasma glucose (PG) value \\<3.1 mmol/L with symptoms consistent with hypoglycaemia. Asymptomatic BG-confirmed: An episode that is BG-confirmed by PG value \\<3.1 mmol/L without symptoms consistent with hypoglycaemia. Severe or BG-confirmed symptomatic: An episode that is severe according to the ISPAD classification or BG-confirmed by a PG value \\<3.1 mmol/L with symptoms consistent with hypoglycaemia. BG-confirmed: An episode that is BG-confirmed by a PG value \\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Severe or BG-confirmed: An episode that is severe according to the International Society for Pediatric and Adolescent Diabetes (ISPAD) classification or BG-confirmed by a PG value \\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"Weeks 0-54; Weeks 54-80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Severe or BG confirmed (Week 0-54)","categories":[{"measurements":[{"groupId":"OG000","value":"396"},{"groupId":"OG001","value":"394"},{"groupId":"OG002","value":"315"},{"groupId":"OG003","value":"503"}]}]},{"title":"Symptomatic BG confirmed (Week 0-54)","categories":[{"measurements":[{"groupId":"OG000","value":"576"},{"groupId":"OG001","value":"616"},{"groupId":"OG002","value":"479"},{"groupId":"OG003","value":"646"}]}]},{"title":"Severe or BG confirmed (Week 54-80)","categories":[{"measurements":[{"groupId":"OG000","value":"216"},{"groupId":"OG001","value":"130"},{"groupId":"OG002","value":"244"},{"groupId":"OG003","value":"240"}]}]},{"title":"Symptomatic BG confirmed (Week 54-80)","categories":[{"measurements":[{"groupId":"OG000","value":"368"},{"groupId":"OG001","value":"207"},{"groupId":"OG002","value":"332"},{"groupId":"OG003","value":"292"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight (kg)","description":"Change in body weight is measured at week 54 and week 80 respective to baseline. Body weight was measured in unit 'Kg'.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilogram (Kg)","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"67"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.8","spread":"4.2"},{"groupId":"OG001","value":"1.2","spread":"5.0"},{"groupId":"OG002","value":"-2.5","spread":"4.0"},{"groupId":"OG003","value":"1.1","spread":"6.1"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.9","spread":"4.6"},{"groupId":"OG001","value":"1.6","spread":"5.2"},{"groupId":"OG002","value":"0.4","spread":"4.7"},{"groupId":"OG003","value":"2.8","spread":"5.5"}]}]}]},{"type":"SECONDARY","title":"Diabetes Retinopathy","description":"Number of participants evaluated for diabetic retinopathy at baseline (Day -28 to -14), week 54 and week 80 are presented as 'yes', 'no' or 'unknown'.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Baseline, week 54 and week 80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Baseline (Day:-28 to -14)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"75"},{"groupId":"OG002","value":"75"},{"groupId":"OG003","value":"76"}]},{"title":"Unknown","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"69"},{"groupId":"OG003","value":"68"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"68"}]},{"title":"Unknown","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"69"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"69"},{"groupId":"OG003","value":"64"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"63"}]},{"title":"Unknown","measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}]}]}]},{"type":"SECONDARY","title":"Estimated Glomerular Filtration Rate (eGFR)- Ratio to Baseline","description":"The eGFR was measured using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. Change in eGFR (measured in milliliters per minute per 1.73 square meters) from baseline (week 0) at week 54 and week 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of eGFR","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.98","spread":"10.3"},{"groupId":"OG001","value":"0.95","spread":"8.2"},{"groupId":"OG002","value":"0.97","spread":"10.2"},{"groupId":"OG003","value":"1.00","spread":"8.8"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.97","spread":"9.3"},{"groupId":"OG001","value":"0.94","spread":"11.4"},{"groupId":"OG002","value":"0.96","spread":"11.5"},{"groupId":"OG003","value":"0.99","spread":"10.9"}]}]}]},{"type":"SECONDARY","title":"Change in Haematology: Erythrocytes","description":"Change in erythrocytes (measured in 10\\^12 cells per liter) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio of erythrocytes","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"6.00"},{"groupId":"OG001","value":"1.01","spread":"6.3"},{"groupId":"OG002","value":"0.99","spread":"7.2"},{"groupId":"OG003","value":"1.00","spread":"6.0"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"6.7"},{"groupId":"OG001","value":"1.00","spread":"6.7"},{"groupId":"OG002","value":"0.99","spread":"7.00"},{"groupId":"OG003","value":"1.00","spread":"5.5"}]}]}]},{"type":"SECONDARY","title":"Change in Haematology: Haematocrit","description":"Change in haematocrit (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio of haematocrit","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"6.6"},{"groupId":"OG001","value":"1.00","spread":"7.00"},{"groupId":"OG002","value":"0.99","spread":"7.8"},{"groupId":"OG003","value":"1.00","spread":"5.9"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.98","spread":"7.5"},{"groupId":"OG001","value":"1.00","spread":"7.3"},{"groupId":"OG002","value":"0.98","spread":"7.2"},{"groupId":"OG003","value":"0.99","spread":"5.8"}]}]}]},{"type":"SECONDARY","title":"Change in Haematology: Haemoglobin","description":"Change in haemoglobin (measured in millimoles per liter 'mmol/L') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio of haemoglobin","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","categories":[{"measurements":[{"groupId":"OG000","value":"1.01","spread":"6.1"},{"groupId":"OG001","value":"1.02","spread":"7.2"},{"groupId":"OG002","value":"1.00","spread":"7.9"},{"groupId":"OG003","value":"1.01","spread":"5.6"}]}]},{"title":"Change from week 0 to week 80","categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"7.5"},{"groupId":"OG001","value":"1.02","spread":"8.2"},{"groupId":"OG002","value":"1.00","spread":"7.4"},{"groupId":"OG003","value":"1.01","spread":"5.6"}]}]}]},{"type":"SECONDARY","title":"Change in Haematology: Leukocytes","description":"Change in leukocytes (measured in 10\\^9 cells/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio of leukocytes","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.96","spread":"27.1"},{"groupId":"OG001","value":"0.98","spread":"21.9"},{"groupId":"OG002","value":"0.97","spread":"23.2"},{"groupId":"OG003","value":"1.02","spread":"24.8"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"33.0"},{"groupId":"OG001","value":"0.95","spread":"19.9"},{"groupId":"OG002","value":"0.99","spread":"29.5"},{"groupId":"OG003","value":"1.00","spread":"24.9"}]}]}]},{"type":"SECONDARY","title":"Change in Haematology: Mean Corpuscular Hemoglobin","description":"Change in mean Corpuscular hemoglobin (measured in femtomole 'fmol') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ratio of mean Corpuscular hemoglobin","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.02","spread":"3.6"},{"groupId":"OG001","value":"1.01","spread":"4.8"},{"groupId":"OG002","value":"1.01","spread":"4.0"},{"groupId":"OG003","value":"1.01","spread":"4.1"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.02","spread":"5.1"},{"groupId":"OG001","value":"1.01","spread":"6.6"},{"groupId":"OG002","value":"1.01","spread":"5.4"},{"groupId":"OG003","value":"1.02","spread":"4.3"}]}]}]},{"type":"SECONDARY","title":"Change in Haematology: Mean Corpuscular Hemoglobin Concentration","description":"Change in mean corpuscular hemoglobin concentration (MCHC) (measured in gram per liter 'g/L') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of MCHC","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.02","spread":"2.9"},{"groupId":"OG001","value":"1.01","spread":"2.1"},{"groupId":"OG002","value":"1.02","spread":"2.6"},{"groupId":"OG003","value":"1.02","spread":"3.0"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.02","spread":"3.5"},{"groupId":"OG001","value":"1.02","spread":"3.1"},{"groupId":"OG002","value":"1.02","spread":"3.0"},{"groupId":"OG003","value":"1.02","spread":"0.29"}]}]}]},{"type":"SECONDARY","title":"Change in Haematology: Mean Corpuscular Volume","description":"Change in Mean Corpuscular volume (measured in femtoliter 'fL') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio of mean corpuscular volume","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"2.8"},{"groupId":"OG001","value":"0.99","spread":"3.8"},{"groupId":"OG002","value":"1.00","spread":"3.3"},{"groupId":"OG003","value":"0.99","spread":"3.3"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"4.3"},{"groupId":"OG001","value":"1.00","spread":"5.2"},{"groupId":"OG002","value":"1.00","spread":"4.3"},{"groupId":"OG003","value":"0.99","spread":"3.7"}]}]}]},{"type":"SECONDARY","title":"Change in Haematology: Thrombocytes","description":"Change in thrombocytes (measured in 10\\^9 cells per liter) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio of thrombocytes","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"66"},{"groupId":"OG003","value":"65"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.98","spread":"14.5"},{"groupId":"OG001","value":"0.98","spread":"15.0"},{"groupId":"OG002","value":"1.03","spread":"13.2"},{"groupId":"OG003","value":"0.98","spread":"14.1"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"66"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"15.0"},{"groupId":"OG001","value":"1.03","spread":"15.7"},{"groupId":"OG002","value":"1.04","spread":"15.6"},{"groupId":"OG003","value":"1.00","spread":"17.3"}]}]}]},{"type":"SECONDARY","title":"Change in Haematology: Eosinophil","description":"Change in eosinophil (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Ratio of eosinophils","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"66"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.15","spread":"0.65"},{"groupId":"OG001","value":"1.30","spread":"1.71"},{"groupId":"OG002","value":"3.10","spread":"13.79"},{"groupId":"OG003","value":"1.37","spread":"1.15"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"66"},{"groupId":"OG003","value":"61"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.31","spread":"1.24"},{"groupId":"OG001","value":"1.23","spread":"1.03"},{"groupId":"OG002","value":"1.54","spread":"1.78"},{"groupId":"OG003","value":"1.36","spread":"1.27"}]}]}]},{"type":"SECONDARY","title":"Change in Haematology: Neutrophils","description":"Change in neutrophils (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio of neutrophils","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"64"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.98","spread":"18.8"},{"groupId":"OG001","value":"0.99","spread":"17.6"},{"groupId":"OG002","value":"0.97","spread":"18.5"},{"groupId":"OG003","value":"1.04","spread":"17.8"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"59"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.97","spread":"17.5"},{"groupId":"OG001","value":"0.99","spread":"14.2"},{"groupId":"OG002","value":"0.98","spread":"20.7"},{"groupId":"OG003","value":"1.04","spread":"17.2"}]}]}]},{"type":"SECONDARY","title":"Change in Haematology: Basophils","description":"Change in basophils (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Ratio of basophils","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"66"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.73","spread":"2.11"},{"groupId":"OG001","value":"1.58","spread":"1.52"},{"groupId":"OG002","value":"1.52","spread":"1.47"},{"groupId":"OG003","value":"1.43","spread":"1.06"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"66"},{"groupId":"OG003","value":"61"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.17","spread":"2.17"},{"groupId":"OG001","value":"1.73","spread":"1.41"},{"groupId":"OG002","value":"2.09","spread":"1.86"},{"groupId":"OG003","value":"1.96","spread":"1.27"}]}]}]},{"type":"SECONDARY","title":"Change in Haematology: Lymphocytes","description":"Change in lymphocytes (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio of lymphocytes","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"66"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"28.5"},{"groupId":"OG001","value":"1.00","spread":"28.3"},{"groupId":"OG002","value":"1.02","spread":"28.4"},{"groupId":"OG003","value":"0.91","spread":"30.7"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"66"},{"groupId":"OG003","value":"61"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.01","spread":"28.0"},{"groupId":"OG001","value":"0.98","spread":"21.8"},{"groupId":"OG002","value":"0.99","spread":"35.1"},{"groupId":"OG003","value":"0.91","spread":"30.6"}]}]}]},{"type":"SECONDARY","title":"Change in Haematology: Monocytes","description":"Change in monocytes (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio of monocytes","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"66"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.05","spread":"40.8"},{"groupId":"OG001","value":"1.02","spread":"34.8"},{"groupId":"OG002","value":"1.01","spread":"41.1"},{"groupId":"OG003","value":"1.01","spread":"34.9"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"66"},{"groupId":"OG003","value":"61"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.12","spread":"44.0"},{"groupId":"OG001","value":"1.07","spread":"37.5"},{"groupId":"OG002","value":"1.04","spread":"42.9"},{"groupId":"OG003","value":"1.12","spread":"35.4"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry: Alanine Aminotransferase (ALAT)","description":"Change in ALAT (measured in units per liter \\[U/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio of ALT","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"66"},{"groupId":"OG003","value":"65"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.96","spread":"47.7"},{"groupId":"OG001","value":"0.98","spread":"35.9"},{"groupId":"OG002","value":"0.97","spread":"46.0"},{"groupId":"OG003","value":"0.90","spread":"44.1"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.95","spread":"54.7"},{"groupId":"OG001","value":"0.98","spread":"39.5"},{"groupId":"OG002","value":"1.06","spread":"40.7"},{"groupId":"OG003","value":"0.92","spread":"40.6"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry: Albumin","description":"Change in albumin (measured in gram per deciliter \\[g/dL\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ratio of albumin","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"7.3"},{"groupId":"OG001","value":"1.00","spread":"6.00"},{"groupId":"OG002","value":"1.02","spread":"7.4"},{"groupId":"OG003","value":"0.99","spread":"7.5"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"6.7"},{"groupId":"OG001","value":"1.01","spread":"6.9"},{"groupId":"OG002","value":"1.00","spread":"6.7"},{"groupId":"OG003","value":"0.99","spread":"6.9"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry: Amylase","description":"Change in amylase (measured in units per liter \\[U/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio of Amylase","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.07","spread":"20.7"},{"groupId":"OG001","value":"0.98","spread":"16.6"},{"groupId":"OG002","value":"1.04","spread":"18.9"},{"groupId":"OG003","value":"1.01","spread":"19.2"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.04","spread":"24.3"},{"groupId":"OG001","value":"0.99","spread":"14.9"},{"groupId":"OG002","value":"1.03","spread":"19.8"},{"groupId":"OG003","value":"1.04","spread":"26.1"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry: Alkaline Phosphatase (ALP)","description":"Change in ALP (measured in units per liter \\[U/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of ALP","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.03","spread":"28.6"},{"groupId":"OG001","value":"0.99","spread":"17.8"},{"groupId":"OG002","value":"0.99","spread":"18.1"},{"groupId":"OG003","value":"1.03","spread":"17.9"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.07","spread":"30.3"},{"groupId":"OG001","value":"1.05","spread":"16.5"},{"groupId":"OG002","value":"1.04","spread":"22.1"},{"groupId":"OG003","value":"1.04","spread":"21.7"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry: Aspartate Aminotransferase (ASAT)","description":"Change in ASAT (measured in units per liter \\[U/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of AST","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"64"},{"groupId":"OG003","value":"65"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"39.3"},{"groupId":"OG001","value":"0.99","spread":"34.5"},{"groupId":"OG002","value":"1.00","spread":"57.0"},{"groupId":"OG003","value":"0.98","spread":"43.1"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"61"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"61"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.98","spread":"39.1"},{"groupId":"OG001","value":"0.98","spread":"32.4"},{"groupId":"OG002","value":"1.09","spread":"34.6"},{"groupId":"OG003","value":"0.99","spread":"39.3"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry: Total Bilirubin","description":"Change in Total bilirubin (measured in micromole per liter \\[umol/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio of total bilirubin","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.81","spread":"61.7"},{"groupId":"OG001","value":"1.10","spread":"56.5"},{"groupId":"OG002","value":"0.99","spread":"49.8"},{"groupId":"OG003","value":"1.01","spread":"59.4"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.91","spread":"44.7"},{"groupId":"OG001","value":"1.04","spread":"74.8"},{"groupId":"OG002","value":"0.98","spread":"55.1"},{"groupId":"OG003","value":"0.99","spread":"58.7"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry: Calcium Corrected","description":"Change in calcium corrected (measured in millimole per liter \\[mmol/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio of calcium","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"3.7"},{"groupId":"OG001","value":"0.98","spread":"3.6"},{"groupId":"OG002","value":"0.98","spread":"4.0"},{"groupId":"OG003","value":"0.99","spread":"4.2"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.96","spread":"3.5"},{"groupId":"OG001","value":"0.97","spread":"4.0"},{"groupId":"OG002","value":"0.98","spread":"3.9"},{"groupId":"OG003","value":"0.98","spread":"4.0"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry: Chloride","description":"Change in chloride (measured in millimole per liter \\[mmol/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio of chloride","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.01","spread":"2.4"},{"groupId":"OG001","value":"1.00","spread":"2.2"},{"groupId":"OG002","value":"1.00","spread":"2.8"},{"groupId":"OG003","value":"1.00","spread":"3.1"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"2.3"},{"groupId":"OG001","value":"1.01","spread":"2.7"},{"groupId":"OG002","value":"1.00","spread":"3.0"},{"groupId":"OG003","value":"1.00","spread":"3.0"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry: Creatine Kinase","description":"Change in creatine kinase (measured in units per liter \\[U/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of Creatine Kinase","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"64"},{"groupId":"OG003","value":"65"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.16","spread":"86.3"},{"groupId":"OG001","value":"1.17","spread":"64.5"},{"groupId":"OG002","value":"1.08","spread":"140.2"},{"groupId":"OG003","value":"1.02","spread":"72.8"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"61"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.11","spread":"48.1"},{"groupId":"OG001","value":"1.09","spread":"68.3"},{"groupId":"OG002","value":"1.24","spread":"87.2"},{"groupId":"OG003","value":"1.13","spread":"76.5"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry: Creatinine","description":"Change in creatinine (measured in micromole per liter \\[umol/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of Creatinine","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.01","spread":"12.0"},{"groupId":"OG001","value":"1.05","spread":"10.6"},{"groupId":"OG002","value":"1.04","spread":"12.8"},{"groupId":"OG003","value":"1.01","spread":"9.9"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.02","spread":"11.2"},{"groupId":"OG001","value":"1.05","spread":"14.3"},{"groupId":"OG002","value":"1.05","spread":"13.1"},{"groupId":"OG003","value":"1.02","spread":"12.3"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry: Gamma-glutamyl Transferase (GGT)","description":"Change in GGT (measured in units per liter \\[U/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of GGT","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"66"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.02","spread":"38.6"},{"groupId":"OG001","value":"1.08","spread":"27.7"},{"groupId":"OG002","value":"1.03","spread":"37.2"},{"groupId":"OG003","value":"1.02","spread":"41.8"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.05","spread":"41.9"},{"groupId":"OG001","value":"1.13","spread":"29.4"},{"groupId":"OG002","value":"1.10","spread":"41.1"},{"groupId":"OG003","value":"1.00","spread":"36.8"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry: C-reactive Protein Serum","description":"Change in C-reactive protein serum (measured in milligrams per liter \\[mg/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of C-reactive protein","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.92","spread":"141.6"},{"groupId":"OG001","value":"1.04","spread":"93.0"},{"groupId":"OG002","value":"0.89","spread":"87.8"},{"groupId":"OG003","value":"1.06","spread":"78.0"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.08","spread":"103.8"},{"groupId":"OG001","value":"0.94","spread":"81.0"},{"groupId":"OG002","value":"1.25","spread":"134.7"},{"groupId":"OG003","value":"1.06","spread":"70.1"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry: Lactate Dehydrogenase","description":"Change in Lactate Dehydrogenase (measured in units per liter \\[U/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of Lactate Dehydrogenase","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"61"},{"groupId":"OG002","value":"62"},{"groupId":"OG003","value":"59"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"12.6"},{"groupId":"OG001","value":"1.03","spread":"18.4"},{"groupId":"OG002","value":"1.04","spread":"23.3"},{"groupId":"OG003","value":"1.03","spread":"16.5"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"60"},{"groupId":"OG002","value":"64"},{"groupId":"OG003","value":"58"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.02","spread":"12.1"},{"groupId":"OG001","value":"1.04","spread":"19.6"},{"groupId":"OG002","value":"1.09","spread":"19.3"},{"groupId":"OG003","value":"1.03","spread":"17.8"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry: Lipase","description":"Change in lipase (measured in units per liter \\[U/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of lipase","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.49","spread":"36.6"},{"groupId":"OG001","value":"1.00","spread":"27.4"},{"groupId":"OG002","value":"1.34","spread":"36.2"},{"groupId":"OG003","value":"1.01","spread":"29.4"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.05","spread":"40.4"},{"groupId":"OG001","value":"0.94","spread":"27.2"},{"groupId":"OG002","value":"1.02","spread":"26.5"},{"groupId":"OG003","value":"0.96","spread":"37.2"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry: Magnesium","description":"Change in magnesium (measured in millimole per liter \\[mmol/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of magnesium","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.02","spread":"8.9"},{"groupId":"OG001","value":"1.01","spread":"7.6"},{"groupId":"OG002","value":"1.02","spread":"7.8"},{"groupId":"OG003","value":"0.99","spread":"8.1"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.01","spread":"10.7"},{"groupId":"OG001","value":"1.03","spread":"11.2"},{"groupId":"OG002","value":"1.02","spread":"9.0"},{"groupId":"OG003","value":"0.98","spread":"9.2"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry: Phosphate","description":"Change in phosphate (measured in millimole per liter \\[mmol/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of phosphate","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"66"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"16.0"},{"groupId":"OG001","value":"0.99","spread":"16.6"},{"groupId":"OG002","value":"1.02","spread":"13.9"},{"groupId":"OG003","value":"0.96","spread":"18.6"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.02","spread":"20.5"},{"groupId":"OG001","value":"1.01","spread":"16.9"},{"groupId":"OG002","value":"1.03","spread":"19.9"},{"groupId":"OG003","value":"0.99","spread":"17.4"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry: Potassium","description":"Change in potassium (measured in millimole per liter \\[mmol/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of potassium","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"64"},{"groupId":"OG003","value":"65"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.01","spread":"8.1"},{"groupId":"OG001","value":"0.98","spread":"6.9"},{"groupId":"OG002","value":"0.99","spread":"8.3"},{"groupId":"OG003","value":"0.98","spread":"10.4"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"61"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"8.3"},{"groupId":"OG001","value":"0.99","spread":"6.9"},{"groupId":"OG002","value":"0.98","spread":"8.5"},{"groupId":"OG003","value":"0.98","spread":"10.0"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry: Sodium","description":"Change in sodium (measured in millimole per liter \\[mmol/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of sodium","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"1.9"},{"groupId":"OG001","value":"1.00","spread":"1.4"},{"groupId":"OG002","value":"1.00","spread":"1.9"},{"groupId":"OG003","value":"1.00","spread":"2.0"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"1.8"},{"groupId":"OG001","value":"1.00","spread":"2.1"},{"groupId":"OG002","value":"1.00","spread":"2.3"},{"groupId":"OG003","value":"1.00","spread":"1.8"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry: Total Protein","description":"Change in total protein (measured in gram per liter \\[g/dL\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of total protein","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"6.8"},{"groupId":"OG001","value":"1.00","spread":"6.0"},{"groupId":"OG002","value":"1.01","spread":"7.2"},{"groupId":"OG003","value":"1.00","spread":"7.6"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"6.5"},{"groupId":"OG001","value":"1.00","spread":"6.4"},{"groupId":"OG002","value":"1.00","spread":"6.6"},{"groupId":"OG003","value":"1.00","spread":"7.4"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry: Blood Urea Nitrogen Serum","description":"Change in blood urea nitrogen serum (measured in milligram per deciliter \\[mg/dL\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of Blood Urea Nitrogen serum","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"27.0"},{"groupId":"OG001","value":"1.05","spread":"22.4"},{"groupId":"OG002","value":"0.98","spread":"22.0"},{"groupId":"OG003","value":"0.94","spread":"23.3"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.97","spread":"33.2"},{"groupId":"OG001","value":"0.97","spread":"26.2"},{"groupId":"OG002","value":"0.98","spread":"28.9"},{"groupId":"OG003","value":"0.97","spread":"28.2"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry: Uric Acid","description":"Change in Uric Acid (measured in milligram per deciliter \\[mg/dL\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of uric acid","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.93","spread":"21.3"},{"groupId":"OG001","value":"0.98","spread":"17.6"},{"groupId":"OG002","value":"0.98","spread":"18.8"},{"groupId":"OG003","value":"0.96","spread":"18.0"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.95","spread":"17.1"},{"groupId":"OG001","value":"0.94","spread":"19.1"},{"groupId":"OG002","value":"0.96","spread":"22.2"},{"groupId":"OG003","value":"0.95","spread":"19.6"}]}]}]},{"type":"SECONDARY","title":"Change in International Normalised Ratio (INR)","description":"Change in INR (measured in ratio\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of INR","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"64"},{"groupId":"OG003","value":"64"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.97","spread":"9.5"},{"groupId":"OG001","value":"0.96","spread":"10.4"},{"groupId":"OG002","value":"0.95","spread":"9.8"},{"groupId":"OG003","value":"0.96","spread":"13.7"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"61"},{"groupId":"OG002","value":"66"},{"groupId":"OG003","value":"59"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.98","spread":"12.4"},{"groupId":"OG001","value":"0.99","spread":"12.9"},{"groupId":"OG002","value":"0.96","spread":"9.2"},{"groupId":"OG003","value":"0.97","spread":"11.5"}]}]}]},{"type":"SECONDARY","title":"Change in D-Dimer","description":"Change in D-Dimer (measured in mg/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of D-dimer","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"66"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.96","spread":"37.6"},{"groupId":"OG001","value":"0.98","spread":"53.9"},{"groupId":"OG002","value":"0.98","spread":"56.8"},{"groupId":"OG003","value":"1.15","spread":"107.1"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"66"},{"groupId":"OG003","value":"61"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.96","spread":"43.7"},{"groupId":"OG001","value":"0.92","spread":"61.3"},{"groupId":"OG002","value":"1.05","spread":"60.0"},{"groupId":"OG003","value":"1.10","spread":"74.3"}]}]}]},{"type":"SECONDARY","title":"Change in Lipids: Total Cholesterol (Ratio to Baseline)","description":"Change in total cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of total cholesterol","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"13.8"},{"groupId":"OG001","value":"1.02","spread":"14.1"},{"groupId":"OG002","value":"1.03","spread":"16.2"},{"groupId":"OG003","value":"1.04","spread":"16.8"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.02","spread":"15.5"},{"groupId":"OG001","value":"1.03","spread":"14.1"},{"groupId":"OG002","value":"1.07","spread":"15.0"},{"groupId":"OG003","value":"1.03","spread":"18.4"}]}]}]},{"type":"SECONDARY","title":"Change in Lipids: Free Fatty Acids (Ratio to Baseline)","description":"Change in total free fatty acids (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of free fatty acids","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"60"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.86","spread":"94.5"},{"groupId":"OG001","value":"1.01","spread":"114.4"},{"groupId":"OG002","value":"1.18","spread":"82.5"},{"groupId":"OG003","value":"0.97","spread":"68.7"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"59"},{"groupId":"OG002","value":"64"},{"groupId":"OG003","value":"61"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.89","spread":"85.3"},{"groupId":"OG001","value":"1.06","spread":"112.8"},{"groupId":"OG002","value":"1.19","spread":"92.8"},{"groupId":"OG003","value":"0.94","spread":"84.0"}]}]}]},{"type":"SECONDARY","title":"Change in Lipids: HDL Cholesterol (Ratio to Baseline)","description":"Change in HDL cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of HDL cholesterol","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.04","spread":"17.3"},{"groupId":"OG001","value":"1.08","spread":"18.2"},{"groupId":"OG002","value":"1.12","spread":"19.6"},{"groupId":"OG003","value":"1.10","spread":"20.2"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.04","spread":"18.7"},{"groupId":"OG001","value":"1.06","spread":"16.7"},{"groupId":"OG002","value":"1.14","spread":"21.5"},{"groupId":"OG003","value":"1.07","spread":"22.2"}]}]}]},{"type":"SECONDARY","title":"Change in Lipids: LDL Cholesterol (Ratio to Baseline)","description":"Change in LDL cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of LDL cholesterol","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.96","spread":"17.8"},{"groupId":"OG001","value":"0.97","spread":"20.9"},{"groupId":"OG002","value":"0.98","spread":"24.0"},{"groupId":"OG003","value":"1.01","spread":"23.6"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"22.2"},{"groupId":"OG001","value":"1.02","spread":"21.2"},{"groupId":"OG002","value":"1.02","spread":"21.2"},{"groupId":"OG003","value":"1.03","spread":"29.2"}]}]}]},{"type":"SECONDARY","title":"Change in Lipids: Triglycerides (TG) (Ratio to Baseline)","description":"Change in Triglycerides (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of TG","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.03","spread":"46.2"},{"groupId":"OG001","value":"0.96","spread":"39.5"},{"groupId":"OG002","value":"1.03","spread":"49.2"},{"groupId":"OG003","value":"1.02","spread":"54.7"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.08","spread":"45.6"},{"groupId":"OG001","value":"0.94","spread":"45.1"},{"groupId":"OG002","value":"1.09","spread":"51.5"},{"groupId":"OG003","value":"0.95","spread":"50.4"}]}]}]},{"type":"SECONDARY","title":"Change in Total Immunoglobulin E (IgE)","description":"Change in IgE (measured in kilo international units per liter \\[kIU/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of IgE","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.31","spread":"71.6"},{"groupId":"OG001","value":"1.05","spread":"63.1"},{"groupId":"OG002","value":"1.08","spread":"45.7"},{"groupId":"OG003","value":"1.02","spread":"41.8"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.32","spread":"65.4"},{"groupId":"OG001","value":"1.18","spread":"38.5"},{"groupId":"OG002","value":"1.16","spread":"55.1"},{"groupId":"OG003","value":"0.94","spread":"61.2"}]}]}]},{"type":"SECONDARY","title":"Change in Urinalysis: Urine Dipsticks","description":"Urinalysis was performed by urine dipsticks for protein, glucose, erythrocytes, ketones leukocytes, nitrite, pH and specific gravity and categorised as normal, abnormal not clinically significant (NCS) and abnormal clinially significant (CS). Number of participants in each category at baseline (week 0), week 54 and 80 are presented.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 0, week 54 and week 80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Week 0: Glucose dipstick","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"72"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"71"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"6"}]},{"title":"Abnormal, 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Gravity","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"75"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"}]},{"title":"Abnormal, CS","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Week 54: Specific Gravity","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"65"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"64"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]},{"title":"Abnormal, CS","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Week 80: Specific Gravity","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]},{"title":"Abnormal, CS","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]}]},{"type":"SECONDARY","title":"Change in Cytokines: Interleukin (IL)-6","description":"IL-6 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product 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Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"picogram per milliliter (pg/mL)","timeFrame":"Week 0, week 54 and week 80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Week 0","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"76"},{"groupId":"OG002","value":"74"},{"groupId":"OG003","value":"75"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.9","spread":"0.6"},{"groupId":"OG001","value":"0.8","spread":"0.1"},{"groupId":"OG002","value":"1.2","spread":"1.8"},{"groupId":"OG003","value":"0.8","spread":"0.3"}]}]},{"title":"Week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"67"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.8","spread":"0.3"},{"groupId":"OG001","value":"0.8","spread":"0.4"},{"groupId":"OG002","value":"1.0","spread":"0.8"},{"groupId":"OG003","value":"0.8","spread":"0.2"}]}]},{"title":"Week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.9","spread":"0.4"},{"groupId":"OG001","value":"0.8","spread":"0.2"},{"groupId":"OG002","value":"0.9","spread":"0.8"},{"groupId":"OG003","value":"0.9","spread":"0.4"}]}]}]},{"type":"SECONDARY","title":"Change in Cytokines- Interleukin (IL)-10","description":"IL-10 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"pg/mL","timeFrame":"Week 0, week 54 and week 80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Week 0","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"75"},{"groupId":"OG002","value":"74"},{"groupId":"OG003","value":"75"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.7","spread":"1.4"},{"groupId":"OG001","value":"0.5","spread":"1.1"},{"groupId":"OG002","value":"0.4","spread":"0.3"},{"groupId":"OG003","value":"0.4","spread":"0.2"}]}]},{"title":"Week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"67"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.4","spread":"0.2"},{"groupId":"OG001","value":"0.4","spread":"0.1"},{"groupId":"OG002","value":"0.4","spread":"0.3"},{"groupId":"OG003","value":"0.4","spread":"0.3"}]}]},{"title":"Week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.4","spread":"0.5"},{"groupId":"OG001","value":"0.4","spread":"0.2"},{"groupId":"OG002","value":"0.5","spread":"0.7"},{"groupId":"OG003","value":"0.4","spread":"0.1"}]}]}]},{"type":"SECONDARY","title":"Change in Cytokines: Interleukin (IL)-17","description":"IL-17 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"pg/mL","timeFrame":"Week 0, week 54 and week 80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Week 0","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"76"},{"groupId":"OG002","value":"74"},{"groupId":"OG003","value":"76"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4.9","spread":"2.0"},{"groupId":"OG001","value":"4.7","spread":"0.7"},{"groupId":"OG002","value":"4.7","spread":"0.0"},{"groupId":"OG003","value":"4.8","spread":"0.9"}]}]},{"title":"Week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"67"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4.9","spread":"1.9"},{"groupId":"OG001","value":"4.8","spread":"1.3"},{"groupId":"OG002","value":"5.1","spread":"3.5"},{"groupId":"OG003","value":"5.4","spread":"5.0"}]}]},{"title":"Week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4.9","spread":"1.7"},{"groupId":"OG001","value":"4.7","spread":"0.0"},{"groupId":"OG002","value":"4.8","spread":"1.2"},{"groupId":"OG003","value":"4.8","spread":"1.0"}]}]}]},{"type":"SECONDARY","title":"Change in Cytokines: Interferon (IFN) Gamma","description":"IFN gamma levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"pg/mL","timeFrame":"Week 0, week 54 and week 80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Week 0","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"76"},{"groupId":"OG002","value":"74"},{"groupId":"OG003","value":"75"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"7.3","spread":"16.1"},{"groupId":"OG001","value":"7.8","spread":"24.0"},{"groupId":"OG002","value":"5.8","spread":"11.6"},{"groupId":"OG003","value":"4.3","spread":"2.8"}]}]},{"title":"Week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"67"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4.6","spread":"4.2"},{"groupId":"OG001","value":"7.5","spread":"19.6"},{"groupId":"OG002","value":"5.0","spread":"6.8"},{"groupId":"OG003","value":"5.8","spread":"7.0"}]}]},{"title":"Week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4.4","spread":"2.8"},{"groupId":"OG001","value":"4.9","spread":"6.4"},{"groupId":"OG002","value":"13.0","spread":"57.5"},{"groupId":"OG003","value":"4.5","spread":"3.4"}]}]}]},{"type":"SECONDARY","title":"Change in Cytokines: TNF-alpha","description":"TNF-alpha levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"pg/mL","timeFrame":"Week 0, week 54 and week 80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Week 0","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"76"},{"groupId":"OG002","value":"74"},{"groupId":"OG003","value":"75"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.60","spread":"1.69"},{"groupId":"OG001","value":"2.32","spread":"0.82"},{"groupId":"OG002","value":"2.70","spread":"1.73"},{"groupId":"OG003","value":"3.06","spread":"3.75"}]}]},{"title":"Week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"67"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.36","spread":"0.75"},{"groupId":"OG001","value":"2.33","spread":"0.59"},{"groupId":"OG002","value":"2.56","spread":"1.11"},{"groupId":"OG003","value":"2.43","spread":"0.65"}]}]},{"title":"Week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.43","spread":"0.66"},{"groupId":"OG001","value":"2.36","spread":"0.68"},{"groupId":"OG002","value":"2.96","spread":"2.39"},{"groupId":"OG003","value":"2.75","spread":"2.47"}]}]}]},{"type":"SECONDARY","title":"Change in Hormone Level: Thyroid Stimulating Hormone (TSH)","description":"Change in TSH (measured in milli international units per liter \\[mIU/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of Thyroid Stimulating Hormone","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"49.9"},{"groupId":"OG001","value":"1.12","spread":"54.1"},{"groupId":"OG002","value":"0.89","spread":"46.6"},{"groupId":"OG003","value":"0.91","spread":"66.1"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.04","spread":"46.7"},{"groupId":"OG001","value":"0.99","spread":"116.1"},{"groupId":"OG002","value":"0.99","spread":"48.5"},{"groupId":"OG003","value":"0.93","spread":"84.5"}]}]}]},{"type":"SECONDARY","title":"Change in Hormone Level: Calcitonin","description":"Change in Calcitonin (measured in nanogram per liter \\[ng/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of Calcitonin","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"67"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"43.5"},{"groupId":"OG001","value":"0.90","spread":"48.5"},{"groupId":"OG002","value":"0.89","spread":"57.2"},{"groupId":"OG003","value":"0.88","spread":"47.4"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.85","spread":"50.9"},{"groupId":"OG001","value":"0.93","spread":"41.8"},{"groupId":"OG002","value":"0.82","spread":"71.5"},{"groupId":"OG003","value":"0.90","spread":"64.5"}]}]}]},{"type":"SECONDARY","title":"Change in Systolic and Diastolic Blood Pressure","description":"Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) are evaluated from baseline (week 0) to weeks 54 and 80.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimeters of mercury (mmHg)","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Week 54: Systolic blood pressure","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"67"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-3","spread":"9"},{"groupId":"OG001","value":"3","spread":"9"},{"groupId":"OG002","value":"-2","spread":"14"},{"groupId":"OG003","value":"1","spread":"11"}]}]},{"title":"Week 80: Systolic blood pressure","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1","spread":"10"},{"groupId":"OG001","value":"2","spread":"11"},{"groupId":"OG002","value":"1","spread":"12"},{"groupId":"OG003","value":"4","spread":"10"}]}]},{"title":"Week 54: Diastolic blood pressure","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"67"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0","spread":"9"},{"groupId":"OG001","value":"2","spread":"9"},{"groupId":"OG002","value":"-1","spread":"10"},{"groupId":"OG003","value":"-1","spread":"8"}]}]},{"title":"Week 80: Diastolic blood pressure","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0","spread":"9"},{"groupId":"OG001","value":"2","spread":"9"},{"groupId":"OG002","value":"1","spread":"10"},{"groupId":"OG003","value":"1","spread":"10"}]}]}]},{"type":"SECONDARY","title":"Change in Pulse","description":"Change in pulse is evaluated from baseline (week 0) to weeks 54 and 80","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Beats/min","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"67"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3","spread":"12"},{"groupId":"OG001","value":"0","spread":"12"},{"groupId":"OG002","value":"6","spread":"9"},{"groupId":"OG003","value":"2","spread":"8"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1","spread":"10"},{"groupId":"OG001","value":"-1","spread":"10"},{"groupId":"OG002","value":"2","spread":"10"},{"groupId":"OG003","value":"1","spread":"9"}]}]}]},{"type":"SECONDARY","title":"Change in Body Temperature","description":"Change in body temperature is evaluated from baseline (week 0) to weeks 54 and 80.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Degree celsius (C)","timeFrame":"Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"67"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.1","spread":"0.4"},{"groupId":"OG001","value":"0.0","spread":"0.6"},{"groupId":"OG002","value":"-0.1","spread":"0.5"},{"groupId":"OG003","value":"-0.0","spread":"0.3"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.0","spread":"0.4"},{"groupId":"OG001","value":"0.1","spread":"0.5"},{"groupId":"OG002","value":"0.0","spread":"0.5"},{"groupId":"OG003","value":"0.0","spread":"0.4"}]}]}]},{"type":"SECONDARY","title":"Change in Respiratory Rate","description":"Change in respiratory rate is evaluated from baseline (week 0) to weeks 54 and 80.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Breaths per minute","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"67"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.3","spread":"2.2"},{"groupId":"OG001","value":"0.1","spread":"3.0"},{"groupId":"OG002","value":"0.1","spread":"2.5"},{"groupId":"OG003","value":"0.6","spread":"2.4"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.3","spread":"2.0"},{"groupId":"OG001","value":"-0.2","spread":"2.7"},{"groupId":"OG002","value":"0.1","spread":"2.5"},{"groupId":"OG003","value":"0.1","spread":"2.2"}]}]}]},{"type":"SECONDARY","title":"Change in Electrocardiogram (ECG)","description":"The ECG was assessed by the investigator at baseline (week 0), week 54 and week 80 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline, week 54 and week 80 are presented.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 0, week 54 and week 80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Week 0","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"60"},{"groupId":"OG003","value":"63"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"16"},{"groupId":"OG003","value":"13"}]},{"title":"Abnormal, CS","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}]},{"title":"Week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"65"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"48"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"46"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"17"},{"groupId":"OG002","value":"12"},{"groupId":"OG003","value":"19"}]},{"title":"Abnormal, CS","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"48"},{"groupId":"OG002","value":"53"},{"groupId":"OG003","value":"50"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"12"}]},{"title":"Abnormal, CS","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]}]},{"type":"SECONDARY","title":"Change in Eye-examination","description":"Dilated fundoscopy or fundus photography was performed by the investigator at week 0, week 54 and week 80. The results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at week 0, week 54 and week 80 are presented.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 0, week 54 and week 80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. 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Gland","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"66"},{"groupId":"OG003","value":"65"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"66"},{"groupId":"OG003","value":"65"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]},{"title":"Abnormal, CS","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Week 80: Thyroid 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Participants was assessed for anti-NNC0114-0006 antibodies. Participant who reported anti-NNC0114-0006 antibodies were further analyzed for cross-reactivity. Number of participants who measured with anti-NNC0114-0006 antibodies at week 54 and week 80 are presented.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 0, week 54 and week 80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"}]}],"classes":[{"title":"Week 0: Anti-NNC0114-0006 antibodies","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"76"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"62"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"14"}]}]},{"title":"Week 0: Cross-reactivity","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"14"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"7"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"7"}]}]},{"title":"Week 54: Anti-NNC0114-0006","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"65"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"62"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"}]}]},{"title":"Week 54: Cross-reactivity","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Week 80: Anti-NNC0114-0006 antibodies","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"64"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"60"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"}]}]},{"title":"Week 80: Cross-reactivity","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}]}]},{"type":"SECONDARY","title":"Occurrence of Anti-liraglutide Antibodies","description":"This outcome measure is applicable for NNC0114-0006 + Liraglutide treatment arm and Liraglutide treatment arm. Participants was assessed for anti-liraglutide antibodies. Participant who reported anti-liraglutide antibodies were further analyzed for cross-reactivity. Number of participants who measured with anti-liraglutide antibodies at week 54 and week 80 are presented.","populationDescription":"The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 0, week 54 and week 80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"76"}]}],"classes":[{"title":"Week 0: Anti-Liraglutide antibodies","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"75"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"75"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Week 0: Cross-reactivity to native GLP-1","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Week 54: Anti-Liraglutide antibodies","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"67"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"65"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}]},{"title":"Week 54: Cross-reactivity to native GLP-1","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]},{"title":"Week 80: Anti-Liraglutide antibodies","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"68"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"66"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}]}]},{"title":"Week 80: Cross-reactivity to native GLP-1","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},{"type":"SECONDARY","title":"Change in Insulin Dose","description":"The total daily insulin dose was derived as the average of the doses reported on the three days prior to the visit. Change in daily total insulin dose from baseline (week 0) after 54 weeks of treatment and week 80 are presented.","populationDescription":"The FAS included all randomised participants. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units per kilograms","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"52"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"49"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.05","spread":"0.18"},{"groupId":"OG001","value":"0.02","spread":"0.18"},{"groupId":"OG002","value":"0.01","spread":"0.23"},{"groupId":"OG003","value":"0.09","spread":"0.19"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"53"},{"groupId":"OG002","value":"50"},{"groupId":"OG003","value":"43"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.10","spread":"0.20"},{"groupId":"OG001","value":"0.05","spread":"0.19"},{"groupId":"OG002","value":"0.11","spread":"0.22"},{"groupId":"OG003","value":"0.12","spread":"0.18"}]}]}]},{"type":"SECONDARY","title":"Change in Number of Insulin Injections","description":"The number of insulin injections was derived as the average of the reported number on the three days prior to the visit. The change in number of insulin injections per day (count) from baseline (week 0) after 54 weeks of treatment and week 80 are presented.","populationDescription":"The FAS included all randomised participants. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Injections per day","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"52"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"49"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.3","spread":"1.5"},{"groupId":"OG001","value":"-0.1","spread":"1.2"},{"groupId":"OG002","value":"-0.5","spread":"1.7"},{"groupId":"OG003","value":"0.2","spread":"1.4"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"53"},{"groupId":"OG002","value":"50"},{"groupId":"OG003","value":"43"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.2","spread":"1.5"},{"groupId":"OG001","value":"-0.3","spread":"1.3"},{"groupId":"OG002","value":"-0.2","spread":"1.5"},{"groupId":"OG003","value":"0.2","spread":"1.3"}]}]}]},{"type":"SECONDARY","title":"Number of Weeks Off Bolus Insulin","description":"The number of weeks off bolus insulin after 54 weeks of treatment and week 80 are presented.","populationDescription":"The FAS included all randomised participants. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Weeks","timeFrame":"(Week 0 to week 54) and (week 0 to week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"55"},{"groupId":"OG002","value":"56"},{"groupId":"OG003","value":"58"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"10","spread":"18"},{"groupId":"OG001","value":"5","spread":"14"},{"groupId":"OG002","value":"9","spread":"18"},{"groupId":"OG003","value":"4","spread":"11"}]}]},{"title":"Week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"52"},{"groupId":"OG002","value":"52"},{"groupId":"OG003","value":"51"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"14","spread":"25"},{"groupId":"OG001","value":"9","spread":"20"},{"groupId":"OG002","value":"12","spread":"24"},{"groupId":"OG003","value":"6","spread":"14"}]}]}]},{"type":"SECONDARY","title":"Change in HbA1c","description":"Change in glycosylated haemoglobin (HbA1c) is evaluated from baseline (week 0) to weeks 54 and 80.","populationDescription":"The FAS included all randomised participants. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage point of HbA1c","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"65"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.7","spread":"1.9"},{"groupId":"OG001","value":"-0.5","spread":"1.4"},{"groupId":"OG002","value":"-0.3","spread":"1.5"},{"groupId":"OG003","value":"-0.3","spread":"1.9"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.1","spread":"1.6"},{"groupId":"OG001","value":"-0.2","spread":"1.5"},{"groupId":"OG002","value":"0.5","spread":"2.1"},{"groupId":"OG003","value":"-0.4","spread":"1.8"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose","description":"Change in fasting plasma glucose is evaluated from baseline (week 0) to weeks 54 and 80.","populationDescription":"The FAS included all randomised participants. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"66"},{"groupId":"OG003","value":"64"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.5","spread":"3.2"},{"groupId":"OG001","value":"0.2","spread":"2.4"},{"groupId":"OG002","value":"-0.3","spread":"3.1"},{"groupId":"OG003","value":"0.5","spread":"2.4"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"61"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"60"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.1","spread":"3.3"},{"groupId":"OG001","value":"0.3","spread":"2.4"},{"groupId":"OG002","value":"0.2","spread":"4.0"},{"groupId":"OG003","value":"1.0","spread":"2.4"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting C-peptide- Ratio to Baseline","description":"Change in fasting C-peptide (measured in nanomole per liter \\[nmol/L\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The FAS included all randomised participants. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of C-peptide","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Ratio from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"66"},{"groupId":"OG003","value":"64"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.01","spread":"76.8"},{"groupId":"OG001","value":"0.70","spread":"71.1"},{"groupId":"OG002","value":"0.65","spread":"102.4"},{"groupId":"OG003","value":"0.66","spread":"116.3"}]}]},{"title":"Ratio from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"64"},{"groupId":"OG003","value":"60"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.58","spread":"112.9"},{"groupId":"OG001","value":"0.53","spread":"106.2"},{"groupId":"OG002","value":"0.42","spread":"132.5"},{"groupId":"OG003","value":"0.54","spread":"154.4"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Glucagon- Ratio to Baseline","description":"Change in fasting glucagon (measured in picogram per milliliter \\[pg/mL\\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.","populationDescription":"The FAS included all randomised participants. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of glucagon","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Ratio from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.01","spread":"32.1"},{"groupId":"OG001","value":"0.95","spread":"32.5"},{"groupId":"OG002","value":"0.96","spread":"31.3"},{"groupId":"OG003","value":"1.00","spread":"31.4"}]}]},{"title":"Ratio from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"61"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.89","spread":"36.2"},{"groupId":"OG001","value":"0.85","spread":"30.7"},{"groupId":"OG002","value":"0.96","spread":"32.8"},{"groupId":"OG003","value":"0.93","spread":"37.8"}]}]}]},{"type":"SECONDARY","title":"7-point SMPG Profiles","description":"Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. 7-point SMPG profile values are presented for week 54 and week 80.","populationDescription":"The FAS included all randomised participants. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 54 and Week 80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Week 54: Before breakfast","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"51"},{"groupId":"OG002","value":"57"},{"groupId":"OG003","value":"45"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6.8","spread":"3.4"},{"groupId":"OG001","value":"6.8","spread":"2.7"},{"groupId":"OG002","value":"6.4","spread":"2.2"},{"groupId":"OG003","value":"6.3","spread":"1.4"}]}]},{"title":"Week 54: 90 minutes after start of breakfast","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"46"},{"groupId":"OG002","value":"53"},{"groupId":"OG003","value":"39"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"8.9","spread":"3.7"},{"groupId":"OG001","value":"7.5","spread":"2.4"},{"groupId":"OG002","value":"7.4","spread":"2.1"},{"groupId":"OG003","value":"7.6","spread":"2.4"}]}]},{"title":"Week 54: Before lunch","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"51"},{"groupId":"OG002","value":"58"},{"groupId":"OG003","value":"46"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.5","spread":"1.8"},{"groupId":"OG001","value":"6.4","spread":"2.3"},{"groupId":"OG002","value":"6.1","spread":"1.8"},{"groupId":"OG003","value":"6.0","spread":"1.6"}]}]},{"title":"Week 54: 90 minutes after start of lunch","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"47"},{"groupId":"OG002","value":"54"},{"groupId":"OG003","value":"39"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"8.2","spread":"2.6"},{"groupId":"OG001","value":"7.5","spread":"2.7"},{"groupId":"OG002","value":"7.8","spread":"2.4"},{"groupId":"OG003","value":"7.7","spread":"2.0"}]}]},{"title":"Week 54: Before dinner","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"48"},{"groupId":"OG002","value":"56"},{"groupId":"OG003","value":"47"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6.5","spread":"1.9"},{"groupId":"OG001","value":"6.5","spread":"2.5"},{"groupId":"OG002","value":"6.6","spread":"2.2"},{"groupId":"OG003","value":"6.1","spread":"1.7"}]}]},{"title":"Week 54: 90 minutes after start of dinner","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"50"},{"groupId":"OG003","value":"35"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"8.2","spread":"3.4"},{"groupId":"OG001","value":"7.0","spread":"2.5"},{"groupId":"OG002","value":"7.2","spread":"2.3"},{"groupId":"OG003","value":"6.8","spread":"1.9"}]}]},{"title":"Week 54: Bedtime","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"49"},{"groupId":"OG002","value":"56"},{"groupId":"OG003","value":"43"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"7.8","spread":"3.9"},{"groupId":"OG001","value":"7.4","spread":"2.6"},{"groupId":"OG002","value":"7.5","spread":"2.5"},{"groupId":"OG003","value":"7.2","spread":"2.1"}]}]},{"title":"Week 80: Before breakfast","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"46"},{"groupId":"OG002","value":"41"},{"groupId":"OG003","value":"44"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6.5","spread":"1.7"},{"groupId":"OG001","value":"6.4","spread":"2.0"},{"groupId":"OG002","value":"7.2","spread":"2.7"},{"groupId":"OG003","value":"6.8","spread":"2.0"}]}]},{"title":"Week 80: 90 minutes after start of breakfast","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"36"},{"groupId":"OG003","value":"40"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"8.5","spread":"2.8"},{"groupId":"OG001","value":"7.2","spread":"3.0"},{"groupId":"OG002","value":"8.3","spread":"3.7"},{"groupId":"OG003","value":"7.5","spread":"2.7"}]}]},{"title":"Week 80: Before lunch","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"46"},{"groupId":"OG002","value":"39"},{"groupId":"OG003","value":"45"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6.2","spread":"2.2"},{"groupId":"OG001","value":"6.2","spread":"2.0"},{"groupId":"OG002","value":"6.9","spread":"3.3"},{"groupId":"OG003","value":"6.1","spread":"1.8"}]}]},{"title":"Week 80: 90 minutes after start of lunch","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"35"},{"groupId":"OG003","value":"40"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"7.8","spread":"2.6"},{"groupId":"OG001","value":"7.6","spread":"2.7"},{"groupId":"OG002","value":"8.5","spread":"4.5"},{"groupId":"OG003","value":"8.0","spread":"3.0"}]}]},{"title":"Week 80: Before dinner","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"45"},{"groupId":"OG002","value":"41"},{"groupId":"OG003","value":"45"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6.5","spread":"2.2"},{"groupId":"OG001","value":"6.7","spread":"2.9"},{"groupId":"OG002","value":"7.6","spread":"4.1"},{"groupId":"OG003","value":"6.5","spread":"1.6"}]}]},{"title":"Week 80: 90 minutes after start of dinner","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"34"},{"groupId":"OG003","value":"40"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"7.6","spread":"2.5"},{"groupId":"OG001","value":"7.0","spread":"2.1"},{"groupId":"OG002","value":"9.0","spread":"5.0"},{"groupId":"OG003","value":"7.6","spread":"2.5"}]}]},{"title":"Week 80: Bedtime","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"44"},{"groupId":"OG002","value":"38"},{"groupId":"OG003","value":"41"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"7.8","spread":"3.0"},{"groupId":"OG001","value":"6.6","spread":"1.8"},{"groupId":"OG002","value":"7.8","spread":"4.4"},{"groupId":"OG003","value":"7.4","spread":"2.2"}]}]}]},{"type":"SECONDARY","title":"Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner","description":"Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Change from baseline (week 0) to week 54 and week 80 in 7-point SMPG postprandial glucose /prandial increment (breakfast, lunch and dinner) value are presented.","populationDescription":"The FAS included all randomised participants. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54: Breakfast","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"29"},{"groupId":"OG002","value":"28"},{"groupId":"OG003","value":"21"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.3","spread":"4.0"},{"groupId":"OG001","value":"0.4","spread":"3.0"},{"groupId":"OG002","value":"-0.1","spread":"3.8"},{"groupId":"OG003","value":"-0.6","spread":"2.4"}]}]},{"title":"Change from week 0 to week 80: Breakfast","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"28"},{"groupId":"OG002","value":"20"},{"groupId":"OG003","value":"19"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.9","spread":"4.2"},{"groupId":"OG001","value":"0.5","spread":"4.0"},{"groupId":"OG002","value":"-0.1","spread":"4.5"},{"groupId":"OG003","value":"-0.5","spread":"4.5"}]}]},{"title":"Change from week 0 to week 54: Lunch","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"32"},{"groupId":"OG002","value":"28"},{"groupId":"OG003","value":"22"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.9","spread":"4.5"},{"groupId":"OG001","value":"0.5","spread":"3.4"},{"groupId":"OG002","value":"1.5","spread":"2.9"},{"groupId":"OG003","value":"0.7","spread":"2.7"}]}]},{"title":"Change from week 0 to week 80: Lunch","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"19"},{"groupId":"OG003","value":"20"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0","spread":"4.5"},{"groupId":"OG001","value":"0.1","spread":"3.0"},{"groupId":"OG002","value":"1.0","spread":"3.5"},{"groupId":"OG003","value":"0.8","spread":"4.5"}]}]},{"title":"Change from week 0 to week 54: Dinner","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"27"},{"groupId":"OG002","value":"22"},{"groupId":"OG003","value":"18"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.1","spread":"4.5"},{"groupId":"OG001","value":"1.1","spread":"4.0"},{"groupId":"OG002","value":"-0.8","spread":"4.7"},{"groupId":"OG003","value":"-0.3","spread":"3.1"}]}]},{"title":"Change from week 0 to week 80: Dinner","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"26"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"19"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.5","spread":"5.0"},{"groupId":"OG001","value":"0.5","spread":"3.4"},{"groupId":"OG002","value":"-0.4","spread":"4.3"},{"groupId":"OG003","value":"-0.4","spread":"3.2"}]}]}]},{"type":"SECONDARY","title":"Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment (Average Over the Three Meals)","description":"Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. Change from baseline (week 0) to week 54 and week 80 in 7-point self-measured plasma glucose (SMPG) postprandial glucose /prandial increment (average over the three meals) value is presented.","populationDescription":"The FAS included all randomised participants. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"33"},{"groupId":"OG002","value":"29"},{"groupId":"OG003","value":"22"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.9","spread":"2.3"},{"groupId":"OG001","value":"0.6","spread":"2.2"},{"groupId":"OG002","value":"0.2","spread":"2.0"},{"groupId":"OG003","value":"-0.1","spread":"2.0"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"31"},{"groupId":"OG002","value":"20"},{"groupId":"OG003","value":"21"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.8","spread":"2.6"},{"groupId":"OG001","value":"0.4","spread":"2.2"},{"groupId":"OG002","value":"0.0","spread":"2.5"},{"groupId":"OG003","value":"-0.0","spread":"2.9"}]}]}]},{"type":"SECONDARY","title":"Change in Mean of 7-point Profiles","description":"Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. Change from baseline (week 0) to week 54 and week 80 in mean of 7-point profiles value is presented.","populationDescription":"The FAS included all randomised participants. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Change from week 0 to week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"34"},{"groupId":"OG003","value":"28"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.5","spread":"2.0"},{"groupId":"OG001","value":"0.3","spread":"2.4"},{"groupId":"OG002","value":"-0.1","spread":"1.9"},{"groupId":"OG003","value":"0.0","spread":"1.2"}]}]},{"title":"Change from week 0 to week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"36"},{"groupId":"OG002","value":"26"},{"groupId":"OG003","value":"27"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.1","spread":"2.1"},{"groupId":"OG001","value":"0.0","spread":"2.3"},{"groupId":"OG002","value":"0.7","spread":"1.6"},{"groupId":"OG003","value":"0.3","spread":"1.7"}]}]}]},{"type":"SECONDARY","title":"Before Breakfast 7- Points Self Measured Plasma Glucose (SMPG)","description":"Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Before breakfast 7-point self-measured plasma glucose (SMPG) profile values are presented at week 54 and week 80.","populationDescription":"The FAS included all randomised participants. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 54 and week 80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"51"},{"groupId":"OG002","value":"57"},{"groupId":"OG003","value":"45"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6.8","spread":"3.4"},{"groupId":"OG001","value":"6.8","spread":"2.7"},{"groupId":"OG002","value":"6.4","spread":"2.2"},{"groupId":"OG003","value":"6.3","spread":"1.4"}]}]},{"title":"Week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"46"},{"groupId":"OG002","value":"41"},{"groupId":"OG003","value":"44"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6.5","spread":"1.7"},{"groupId":"OG001","value":"6.4","spread":"2.0"},{"groupId":"OG002","value":"7.2","spread":"2.7"},{"groupId":"OG003","value":"6.8","spread":"2.0"}]}]}]},{"type":"SECONDARY","title":"Area Under the NNC0114-0006 Concentration-time Curve Over a Dosing Interval at Steady State (AUCtau, NNC0114-0006)","description":"AUCtau, NNC0114-0006 was derived as the area under the concentration-time curve using the linear trapezoidal technique based on observed values and actual measurement times between 0 and 6 weeks (after the last dose). This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.","populationDescription":"The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"day*microgram per milliliter (day*ug/mL)","timeFrame":"Pre-dose and 1 hour post-dose during week 48 to week 54","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"16"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3969","spread":"17.9"},{"groupId":"OG001","value":"4115","spread":"23.1"}]}]}]},{"type":"SECONDARY","title":"Terminal Half-life (t½) After Last Dose of NNC0114-0006","description":"Terminal half life was calculated as log(2)/λz. The terminal rate constant λz was determined through linear regression with the logarithm to concentration as the response variable and actual measurement time as the explanatory variable. Valid observations from the terminal part of the curve, which is approximately linear, were used for the determination. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.","populationDescription":"The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Days","timeFrame":"Pre-dose and 1 hour post-dose during week 48 to week 80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"16"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"22.3","spread":"17.9"},{"groupId":"OG001","value":"22.2","spread":"16.5"}]}]}]},{"type":"SECONDARY","title":"Apparent Volume of Distribution of NNC0114-0006 at Steadystate (Vss, NNC0114-0006)","description":"The apparent volume of distribution of NNC0114-0006 at steady-state was calculated as mean residence time of (MRT) of NNC0114-0006 multiplied by clearance of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.","populationDescription":"The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Milliliters per kilogram (mL/kg)","timeFrame":"Pre-dose and 1 hour post-dose during week 48 to week 80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"16"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"83.7","spread":"23.1"},{"groupId":"OG001","value":"79.3","spread":"17.6"}]}]}]},{"type":"SECONDARY","title":"Clearance of NNC0114-0006 at Steady State (CLss, NNC0114-0006)","description":"Clearance of NNC0114-0006 at steady state was calculated as dose/AUCtau, NNC0114-0006. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.","populationDescription":"The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"(Milliliters/day)/kilogram ([mL/day]/kg)","timeFrame":"Pre-dose and 1 hour post-dose during week 48 to week 54","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"16"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.02","spread":"17.9"},{"groupId":"OG001","value":"2.92","spread":"23.1"}]}]}]},{"type":"SECONDARY","title":"Mean Residence Time of NNC0114-0006 (MRT, NNC0114-0006)","description":"This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms. Mean residence time of NNC0114-0006 is presented.","populationDescription":"The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Days","timeFrame":"Pre-dose and 1 hour post-dose during week 48 to week 80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"16"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"27.7","spread":"24.5"},{"groupId":"OG001","value":"27.2","spread":"22.6"}]}]}]},{"type":"SECONDARY","title":"Accumulation Ratio of NNC114-0006 (RA,AUC, NNC0114-0006)","description":"Accumulation ratio of NNC114-0006 was defined as AUC48-54 weeks/AUC0-6 weeks. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.","populationDescription":"The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of AUC","timeFrame":"Pre-dose and 1 hour post-dose during (week 0 to week 6) and (week 48 to week 54)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"16"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.24","spread":"17.8"},{"groupId":"OG001","value":"1.26","spread":"17.4"}]}]}]},{"type":"SECONDARY","title":"Observed NNC0114-0006 Concentration Prior to Dosing of NNC0114-0006 at Steady State (Ctrough, NNC0114-0006)","description":"Ctrough of NNC0114-0006 was defined as concentration prior to dosing of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.","populationDescription":"The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"microgram/milliliter (ug/mL)","timeFrame":"Week 48 (predose)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"16"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"34.7","spread":"42.3"},{"groupId":"OG001","value":"36.7","spread":"36.8"}]}]}]},{"type":"SECONDARY","title":"Observed NNC0114-0006 Concentration 1 Hour After Dosing of NNC0114-0006 at Steady State (C1h, NNC0114-0006)","description":"C1h, NNC0114-0006 was defined as concentration of NNC0114-0006 at 1 hour after dosing of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.","populationDescription":"The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ug/mL","timeFrame":"Week 48 (1 hour post-dose)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"15"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"298.6","spread":"16.8"},{"groupId":"OG001","value":"282.6","spread":"56.4"}]}]}]},{"type":"SECONDARY","title":"Liraglutide Concentration at Steady State (C Liraglutide)","description":"C liraglutide was defined as the liraglutide concentration at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and Liraglutide treatment arms.","populationDescription":"The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"picomole per liter (pmol/L)","timeFrame":"Week 54 (post-dose)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"19"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16287","spread":"41.7"},{"groupId":"OG001","value":"15920","spread":"66.0"}]}]}]},{"type":"SECONDARY","title":"Change in Biomarker: Immune Phenotyping- B Cell Panel","description":"B cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80.\n\nIn below table CD refer to Cluster of Differentiation; IgMNeg refers to Immunoglobulin M negative; IgDNeg refers to Immunoglobulin D negative.","populationDescription":"The FAS included all randomised participants. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of B cells (%)","timeFrame":"Week 0, week 54 and week 80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Week 0: Activated Memory B-Cells","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"70"},{"groupId":"OG002","value":"62"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.3","spread":"0.9"},{"groupId":"OG001","value":"1.4","spread":"1.0"},{"groupId":"OG002","value":"1.6","spread":"1.1"},{"groupId":"OG003","value":"1.5","spread":"1.0"}]}]},{"title":"Week 54: Activated Memory 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B-Cells","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"70"},{"groupId":"OG002","value":"62"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"15.1","spread":"6.7"},{"groupId":"OG001","value":"14.0","spread":"7.1"},{"groupId":"OG002","value":"13.6","spread":"6.9"},{"groupId":"OG003","value":"13.3","spread":"7.4"}]}]},{"title":"Week 54: Mature Naive B-Cells","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"56"},{"groupId":"OG002","value":"57"},{"groupId":"OG003","value":"58"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"14.0","spread":"6.2"},{"groupId":"OG001","value":"14.3","spread":"7.9"},{"groupId":"OG002","value":"13.6","spread":"7.6"},{"groupId":"OG003","value":"13.5","spread":"6.9"}]}]},{"title":"Week 80: Mature Naive B-Cells","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"53"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"56"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"14.3","spread":"7.3"},{"groupId":"OG001","value":"14.2","spread":"8.7"},{"groupId":"OG002","value":"12.0","spread":"5.2"},{"groupId":"OG003","value":"12.8","spread":"7.6"}]}]},{"title":"Week 0: Antibody-Secreting Cells","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"70"},{"groupId":"OG002","value":"62"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.6","spread":"0.4"},{"groupId":"OG001","value":"0.5","spread":"0.5"},{"groupId":"OG002","value":"0.6","spread":"0.3"},{"groupId":"OG003","value":"0.6","spread":"0.6"}]}]},{"title":"Week 54: Antibody-Secreting Cells","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"56"},{"groupId":"OG002","value":"57"},{"groupId":"OG003","value":"58"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.6","spread":"0.5"},{"groupId":"OG001","value":"0.4","spread":"0.4"},{"groupId":"OG002","value":"0.5","spread":"0.3"},{"groupId":"OG003","value":"0.6","spread":"0.7"}]}]},{"title":"Week 80: Antibody-Secreting Cells","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"53"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"56"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.5","spread":"0.4"},{"groupId":"OG001","value":"0.4","spread":"0.3"},{"groupId":"OG002","value":"0.4","spread":"0.4"},{"groupId":"OG003","value":"0.6","spread":"0.5"}]}]},{"title":"Week 0: B-Cells Positive For Both CD19 & CD20","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"70"},{"groupId":"OG002","value":"62"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"71.9","spread":"9.7"},{"groupId":"OG001","value":"71.1","spread":"11.1"},{"groupId":"OG002","value":"72.1","spread":"8.9"},{"groupId":"OG003","value":"72.2","spread":"8.8"}]}]},{"title":"Week 54: B-Cells Positive For Both CD19 & CD20","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"56"},{"groupId":"OG002","value":"57"},{"groupId":"OG003","value":"58"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"71.1","spread":"12.4"},{"groupId":"OG001","value":"70.8","spread":"12.4"},{"groupId":"OG002","value":"72.1","spread":"8.4"},{"groupId":"OG003","value":"65.9","spread":"13.6"}]}]},{"title":"Week 80: B-Cells Positive For Both CD19 & CD20","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"53"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"56"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"71.0","spread":"10.7"},{"groupId":"OG001","value":"69.8","spread":"11.2"},{"groupId":"OG002","value":"72.8","spread":"10.6"},{"groupId":"OG003","value":"69.6","spread":"13.5"}]}]},{"title":"Week 0: CD20Neg B-Cell","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"70"},{"groupId":"OG002","value":"62"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.6","spread":"0.5"},{"groupId":"OG001","value":"0.6","spread":"0.7"},{"groupId":"OG002","value":"0.6","spread":"0.7"},{"groupId":"OG003","value":"0.6","spread":"0.5"}]}]},{"title":"Week 54: CD20Neg B-Cell","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"56"},{"groupId":"OG002","value":"57"},{"groupId":"OG003","value":"58"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.6","spread":"0.7"},{"groupId":"OG001","value":"0.5","spread":"0.9"},{"groupId":"OG002","value":"0.5","spread":"0.4"},{"groupId":"OG003","value":"0.6","spread":"0.7"}]}]},{"title":"Week 80: CD20Neg B-Cell","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"53"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"56"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.5","spread":"0.3"},{"groupId":"OG001","value":"0.5","spread":"0.4"},{"groupId":"OG002","value":"0.6","spread":"1.8"},{"groupId":"OG003","value":"0.7","spread":"1.0"}]}]},{"title":"Week 0: CD24- B-Cells","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"70"},{"groupId":"OG002","value":"62"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"29.8","spread":"10.2"},{"groupId":"OG001","value":"31.0","spread":"11.5"},{"groupId":"OG002","value":"31.5","spread":"11.8"},{"groupId":"OG003","value":"32.0","spread":"11.1"}]}]},{"title":"Week 54: CD24- B-Cells","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"56"},{"groupId":"OG002","value":"57"},{"groupId":"OG003","value":"58"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"30.2","spread":"9.4"},{"groupId":"OG001","value":"30.6","spread":"10.8"},{"groupId":"OG002","value":"31.3","spread":"11.9"},{"groupId":"OG003","value":"28.3","spread":"8.9"}]}]},{"title":"Week 80: CD24- B-Cells","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"53"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"56"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"30.0","spread":"8.9"},{"groupId":"OG001","value":"31.6","spread":"10.9"},{"groupId":"OG002","value":"33.4","spread":"12.4"},{"groupId":"OG003","value":"30.7","spread":"11.8"}]}]},{"title":"Week 0: Class-Switched Memory B Cells","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"70"},{"groupId":"OG002","value":"62"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.0","spread":"3.3"},{"groupId":"OG001","value":"4.6","spread":"2.5"},{"groupId":"OG002","value":"4.8","spread":"3.3"},{"groupId":"OG003","value":"4.9","spread":"3.0"}]}]},{"title":"Week 54: Class-Switched Memory B Cells","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"56"},{"groupId":"OG002","value":"57"},{"groupId":"OG003","value":"58"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.0","spread":"3.7"},{"groupId":"OG001","value":"4.2","spread":"2.3"},{"groupId":"OG002","value":"4.6","spread":"2.9"},{"groupId":"OG003","value":"4.8","spread":"2.9"}]}]},{"title":"Week 80: Class-Switched Memory B Cells","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"53"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"56"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4.6","spread":"3.3"},{"groupId":"OG001","value":"3.6","spread":"2.0"},{"groupId":"OG002","value":"4.6","spread":"3.0"},{"groupId":"OG003","value":"4.5","spread":"2.5"}]}]},{"title":"Week 0: IgMNeg IgDNeg Switched Memory B-cells","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"70"},{"groupId":"OG002","value":"62"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.1","spread":"0.1"},{"groupId":"OG001","value":"0.1","spread":"0.1"},{"groupId":"OG002","value":"0.1","spread":"0.1"},{"groupId":"OG003","value":"0.1","spread":"0.1"}]}]},{"title":"Week 54: IgMNeg IgDNeg Switched Memory B-cells","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"56"},{"groupId":"OG002","value":"57"},{"groupId":"OG003","value":"58"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.1","spread":"0.1"},{"groupId":"OG001","value":"0.1","spread":"0.1"},{"groupId":"OG002","value":"0.1","spread":"0.2"},{"groupId":"OG003","value":"0.1","spread":"0.1"}]}]},{"title":"Week 80: IgMNeg IgDNeg Switched Memory B-cells","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"53"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"56"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.1","spread":"0.1"},{"groupId":"OG001","value":"0.2","spread":"0.2"},{"groupId":"OG002","value":"0.1","spread":"0.1"},{"groupId":"OG003","value":"0.1","spread":"0.1"}]}]},{"title":"Week 0: Non-Class Switched Memory B-Cells","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"70"},{"groupId":"OG002","value":"62"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"10.2","spread":"6.4"},{"groupId":"OG001","value":"9.6","spread":"5.8"},{"groupId":"OG002","value":"9.6","spread":"5.8"},{"groupId":"OG003","value":"10.1","spread":"6.4"}]}]},{"title":"Week 54: Non-Class Switched Memory B-Cells","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"56"},{"groupId":"OG002","value":"57"},{"groupId":"OG003","value":"58"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"8.5","spread":"4.8"},{"groupId":"OG001","value":"9.0","spread":"5.7"},{"groupId":"OG002","value":"8.7","spread":"5.8"},{"groupId":"OG003","value":"8.9","spread":"5.8"}]}]},{"title":"Week 80: Non-Class Switched Memory B-Cells","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"53"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"56"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"8.2","spread":"4.9"},{"groupId":"OG001","value":"7.2","spread":"4.1"},{"groupId":"OG002","value":"8.0","spread":"5.1"},{"groupId":"OG003","value":"8.9","spread":"6.2"}]}]},{"title":"Week 0: Total B-Cell Population","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"70"},{"groupId":"OG002","value":"62"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"72.5","spread":"9.8"},{"groupId":"OG001","value":"71.7","spread":"11.2"},{"groupId":"OG002","value":"72.7","spread":"9.0"},{"groupId":"OG003","value":"72.8","spread":"8.6"}]}]},{"title":"Week 54: Total B-Cell Population","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"56"},{"groupId":"OG002","value":"57"},{"groupId":"OG003","value":"58"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"71.7","spread":"12.1"},{"groupId":"OG001","value":"71.3","spread":"11.9"},{"groupId":"OG002","value":"72.6","spread":"8.4"},{"groupId":"OG003","value":"66.5","spread":"13.3"}]}]},{"title":"Week 80: Total B-Cell Population","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"53"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"56"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"71.4","spread":"10.7"},{"groupId":"OG001","value":"70.3","spread":"11.2"},{"groupId":"OG002","value":"73.5","spread":"9.6"},{"groupId":"OG003","value":"70.4","spread":"13.0"}]}]},{"title":"Week 0: Transitional B-Cells","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"70"},{"groupId":"OG002","value":"62"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"11.4","spread":"6.1"},{"groupId":"OG001","value":"9.9","spread":"6.5"},{"groupId":"OG002","value":"9.5","spread":"5.5"},{"groupId":"OG003","value":"9.6","spread":"6.6"}]}]},{"title":"Week 54: Transitional B-Cells","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"56"},{"groupId":"OG002","value":"57"},{"groupId":"OG003","value":"58"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"10.2","spread":"5.6"},{"groupId":"OG001","value":"10.7","spread":"7.7"},{"groupId":"OG002","value":"9.5","spread":"6.3"},{"groupId":"OG003","value":"9.8","spread":"6.4"}]}]},{"title":"Week 80: Transitional B-Cells","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"53"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"56"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"10.8","spread":"6.8"},{"groupId":"OG001","value":"10.5","spread":"8.1"},{"groupId":"OG002","value":"8.1","spread":"4.0"},{"groupId":"OG003","value":"8.9","spread":"6.1"}]}]}]},{"type":"SECONDARY","title":"Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel","description":"NK cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80.\n\nIn below table ADCC refer to Antibody-dependent cellular cytotoxicity; CD refer to Cluster of Differentiation.","populationDescription":"The FAS included all randomised participants. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of NK cells (%)","timeFrame":"Week 0, week 54 and week 80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. 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Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Week 0","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"30"},{"groupId":"OG003","value":"36"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"47"},{"groupId":"OG002","value":"46"},{"groupId":"OG003","value":"41"}]}]},{"title":"Week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"66"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"28"},{"groupId":"OG002","value":"27"},{"groupId":"OG003","value":"33"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"41"},{"groupId":"OG003","value":"33"}]}]},{"title":"Week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"31"},{"groupId":"OG003","value":"33"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"37"},{"groupId":"OG003","value":"29"}]}]}]},{"type":"SECONDARY","title":"Autoantibodies Against Islet Antigen-2 (IA2)","description":"Participants were analyzed for autoantibodies against Islet antigen-2 (IA2) and were categorized as negative and positive.","populationDescription":"The FAS included all randomised participants. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 0, week 54 and week 80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Week 0","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"31"},{"groupId":"OG003","value":"45"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"45"},{"groupId":"OG003","value":"32"}]}]},{"title":"Week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"66"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"33"},{"groupId":"OG002","value":"28"},{"groupId":"OG003","value":"38"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"32"},{"groupId":"OG002","value":"40"},{"groupId":"OG003","value":"28"}]}]},{"title":"Week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"38"},{"groupId":"OG002","value":"29"},{"groupId":"OG003","value":"35"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"26"},{"groupId":"OG002","value":"39"},{"groupId":"OG003","value":"27"}]}]}]},{"type":"SECONDARY","title":"Autoantibodies Against Insulin Autoantibodies (IAA)","description":"Participants were analyzed for autoantibodies against Insulin autoantibodies (IAA) and were categorized as negative and positive.","populationDescription":"The FAS included all randomised participants. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 0, week 54 and week 80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Week 0","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"76"},{"groupId":"OG002","value":"75"},{"groupId":"OG003","value":"76"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"28"},{"groupId":"OG002","value":"26"},{"groupId":"OG003","value":"36"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"48"},{"groupId":"OG002","value":"49"},{"groupId":"OG003","value":"40"}]}]},{"title":"Week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"66"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"28"},{"groupId":"OG002","value":"22"},{"groupId":"OG003","value":"11"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"46"},{"groupId":"OG003","value":"55"}]}]},{"title":"Week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"24"},{"groupId":"OG002","value":"13"},{"groupId":"OG003","value":"15"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"47"}]}]}]},{"type":"SECONDARY","title":"Change in Biomarker: Total Interleukin-21 (IL-21)","description":"IL-21 is evaluated at baseline (week 0), week 54 and week 80.","populationDescription":"The FAS included all randomised participants. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"picogram per milliliter","timeFrame":"Week 0, week 54 and week 80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Week 0","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"72"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"28.8","spread":"10.2"},{"groupId":"OG001","value":"31.1","spread":"10.8"},{"groupId":"OG002","value":"30.9","spread":"10.7"},{"groupId":"OG003","value":"30.2","spread":"10.2"}]}]},{"title":"Week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"66"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3993.5","spread":"2145.4"},{"groupId":"OG001","value":"4368.2","spread":"2374.9"},{"groupId":"OG002","value":"25.0","spread":"0.0"},{"groupId":"OG003","value":"34.1","spread":"68.1"}]}]},{"title":"Week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"540.9","spread":"495.3"},{"groupId":"OG001","value":"674.1","spread":"648.1"},{"groupId":"OG002","value":"28.0","spread":"8.2"},{"groupId":"OG003","value":"30.7","spread":"17.2"}]}]}]},{"type":"SECONDARY","title":"Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol)","description":"Serum vitamin D is evaluated at baseline (week 0), week 54 and week 80.","populationDescription":"The FAS included all randomised participants. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"picomole per liter","timeFrame":"Week 0, week 54 and week 80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Week 0","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"72"},{"groupId":"OG002","value":"67"},{"groupId":"OG003","value":"70"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"123","spread":"30"},{"groupId":"OG001","value":"122","spread":"39"},{"groupId":"OG002","value":"122","spread":"29"},{"groupId":"OG003","value":"120","spread":"33"}]}]},{"title":"Week 54","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"64"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"117","spread":"31"},{"groupId":"OG001","value":"125","spread":"36"},{"groupId":"OG002","value":"113","spread":"30"},{"groupId":"OG003","value":"119","spread":"32"}]}]},{"title":"Week 80","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"66"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"119","spread":"41"},{"groupId":"OG001","value":"124","spread":"49"},{"groupId":"OG002","value":"121","spread":"38"},{"groupId":"OG003","value":"115","spread":"33"}]}]}]},{"type":"SECONDARY","title":"Change in Short Form 36 Health Survey (SF-36)","description":"SF-36v2™ questionnaire measured the HRQoL on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. Change from baseline (week 0) to week 54 and week 80 in SF-36 score is presented.The MCS measure is derived from domain scales of vitality, social functioning, role emotional and mental health. The PCS measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicate an improvement since baseline.","populationDescription":"The FAS included all randomised participants. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Week 54: Bodily pain","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"73"},{"groupId":"OG003","value":"72"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.8","spread":"8.5"},{"groupId":"OG001","value":"-2.2","spread":"7.6"},{"groupId":"OG002","value":"0.1","spread":"5.2"},{"groupId":"OG003","value":"0.6","spread":"9.1"}]}]},{"title":"Week 80: Bodily Pain","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.8","spread":"7.8"},{"groupId":"OG001","value":"-1.4","spread":"7.0"},{"groupId":"OG002","value":"-0.5","spread":"6.4"},{"groupId":"OG003","value":"0.8","spread":"10.2"}]}]},{"title":"Week 54: General Health Perception","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"73"},{"groupId":"OG003","value":"72"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.1","spread":"7.1"},{"groupId":"OG001","value":"-0.3","spread":"8.4"},{"groupId":"OG002","value":"-1.6","spread":"7.3"},{"groupId":"OG003","value":"-1.0","spread":"7.1"}]}]},{"title":"Week 80: General Health Perception","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.9","spread":"7.2"},{"groupId":"OG001","value":"0.6","spread":"9.0"},{"groupId":"OG002","value":"-1.7","spread":"7.9"},{"groupId":"OG003","value":"-1.8","spread":"8.6"}]}]},{"title":"Week 54: Mental Component Sum","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"73"},{"groupId":"OG003","value":"72"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.5","spread":"9.4"},{"groupId":"OG001","value":"0.6","spread":"9.3"},{"groupId":"OG002","value":"-2.1","spread":"9.0"},{"groupId":"OG003","value":"-1.3","spread":"7.6"}]}]},{"title":"Week 80: Mental Component Sum","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.7","spread":"9.8"},{"groupId":"OG001","value":"-0.4","spread":"8.9"},{"groupId":"OG002","value":"-2.4","spread":"9.6"},{"groupId":"OG003","value":"-0.7","spread":"8.7"}]}]},{"title":"week 54: Mental Health","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"73"},{"groupId":"OG003","value":"72"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.7","spread":"8.4"},{"groupId":"OG001","value":"0.6","spread":"7.9"},{"groupId":"OG002","value":"-1.5","spread":"8.6"},{"groupId":"OG003","value":"-1.3","spread":"6.9"}]}]},{"title":"Week 80: Mental Health","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.5","spread":"8.6"},{"groupId":"OG001","value":"-0.2","spread":"8.0"},{"groupId":"OG002","value":"-1.5","spread":"9.0"},{"groupId":"OG003","value":"-0.7","spread":"7.6"}]}]},{"title":"Week 54: Physical Component Sum","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"73"},{"groupId":"OG003","value":"72"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"4.2"},{"groupId":"OG001","value":"-0.4","spread":"5.3"},{"groupId":"OG002","value":"-0.1","spread":"3.8"},{"groupId":"OG003","value":"0.3","spread":"5.7"}]}]},{"title":"Week 80: Physical Component Sum","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.1","spread":"3.9"},{"groupId":"OG001","value":"0.5","spread":"5.4"},{"groupId":"OG002","value":"0.0","spread":"4.3"},{"groupId":"OG003","value":"0.0","spread":"6.9"}]}]},{"title":"Week 54: Physical Functioning","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"73"},{"groupId":"OG003","value":"72"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.6","spread":"2.5"},{"groupId":"OG001","value":"0.9","spread":"4.4"},{"groupId":"OG002","value":"0.0","spread":"2.6"},{"groupId":"OG003","value":"0.3","spread":"5.8"}]}]},{"title":"Week 80: Physical Functioning","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.5","spread":"2.9"},{"groupId":"OG001","value":"1.1","spread":"4.6"},{"groupId":"OG002","value":"-0.1","spread":"2.4"},{"groupId":"OG003","value":"0.1","spread":"6.4"}]}]},{"title":"Week 54:Lim Emotion Prob","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"73"},{"groupId":"OG003","value":"72"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.3","spread":"10.7"},{"groupId":"OG001","value":"0.5","spread":"8.9"},{"groupId":"OG002","value":"-1.4","spread":"9.0"},{"groupId":"OG003","value":"-0.1","spread":"8.5"}]}]},{"title":"Week 80: Lim Emotion Prob","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.2","spread":"10.8"},{"groupId":"OG001","value":"-0.1","spread":"9.8"},{"groupId":"OG002","value":"-2.2","spread":"9.4"},{"groupId":"OG003","value":"0.0","spread":"8.3"}]}]},{"title":"Week 54: Lim. Phy Health","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"73"},{"groupId":"OG003","value":"72"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.3","spread":"5.8"},{"groupId":"OG001","value":"0.7","spread":"6.9"},{"groupId":"OG002","value":"-0.6","spread":"5.7"},{"groupId":"OG003","value":"-0.2","spread":"6.9"}]}]},{"title":"Week 80: Lim. Phy Health","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.8","spread":"6.4"},{"groupId":"OG001","value":"0.9","spread":"7.0"},{"groupId":"OG002","value":"-0.2","spread":"5.2"},{"groupId":"OG003","value":"0.0","spread":"7.3"}]}]},{"title":"Week 54: Social Functioning","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"73"},{"groupId":"OG003","value":"72"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.8","spread":"10.3"},{"groupId":"OG001","value":"0.1","spread":"10.0"},{"groupId":"OG002","value":"-1.4","spread":"7.4"},{"groupId":"OG003","value":"0.0","spread":"8.5"}]}]},{"title":"Week 80: Social Functioning","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.3","spread":"9.9"},{"groupId":"OG001","value":"1.0","spread":"8.3"},{"groupId":"OG002","value":"-1.2","spread":"7.3"},{"groupId":"OG003","value":"-0.4","spread":"8.4"}]}]},{"title":"Week 54: Vitality","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"73"},{"groupId":"OG003","value":"72"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.5","spread":"8.2"},{"groupId":"OG001","value":"0.5","spread":"7.9"},{"groupId":"OG002","value":"-2.2","spread":"5.9"},{"groupId":"OG003","value":"-2.3","spread":"6.9"}]}]},{"title":"Week 80: Vitality","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.5","spread":"7.9"},{"groupId":"OG001","value":"-1.4","spread":"6.9"},{"groupId":"OG002","value":"-2.2","spread":"7.1"},{"groupId":"OG003","value":"-0.7","spread":"6.9"}]}]}]},{"type":"SECONDARY","title":"Change in Experience of Treatment Benefits and Barriers (ETBB)","description":"Treatment Benefits and Barriers (ETBB) questionnaire measured diabetes-specific health beliefs on 2 categories: Total Score for Perceived Barriers and Perceived Benefits. The measurement of perceived benefits of, and barriers to, treatment was achieved by creating a pool 28 statements each with a 7-point scale ranging from strongly agree (6) to strongly disagree (0). ETBB benefits score was calculated using the responses from questions 1, 4, 7, 8, 10, and 12 and ETBB barriers score was calculated using the responses from questions 2, 3, 5, 6, 9, and 11. Both was calculated as the sum of responses divided by number of responses received multiplied by the maximum number of responses. Based on the responses used the maximum responses available was 6. The higher score indicates more perceived benefits or more perceived barrier.","populationDescription":"The FAS included all randomised participants. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Week 54: Total Score for Perceived Barriers","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"73"},{"groupId":"OG003","value":"72"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.2","spread":"8.3"},{"groupId":"OG001","value":"-1.8","spread":"7.7"},{"groupId":"OG002","value":"-0.2","spread":"8.2"},{"groupId":"OG003","value":"-0.3","spread":"6.3"}]}]},{"title":"Week 80: Total Score for Perceived Barriers","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2.0","spread":"7.8"},{"groupId":"OG001","value":"-2.0","spread":"7.5"},{"groupId":"OG002","value":"-0.1","spread":"6.7"},{"groupId":"OG003","value":"0.1","spread":"8.3"}]}]},{"title":"Week 54: Total Score for Perceived Benefits","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"73"},{"groupId":"OG003","value":"72"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.6","spread":"5.6"},{"groupId":"OG001","value":"1.1","spread":"4.2"},{"groupId":"OG002","value":"0.2","spread":"5.7"},{"groupId":"OG003","value":"-0.5","spread":"6.3"}]}]},{"title":"Week 80: Total Score for Perceived Benefits","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.1","spread":"5.8"},{"groupId":"OG001","value":"1.1","spread":"4.8"},{"groupId":"OG002","value":"1.3","spread":"6.2"},{"groupId":"OG003","value":"-0.4","spread":"5.1"}]}]}]},{"type":"SECONDARY","title":"Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ)","description":"Change from baseline (week 0) in DTSQ is evaluated at week 54 and 80. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher score indicates a higher level of glycaemia/treatment satisfaction.","populationDescription":"The FAS included all randomised participants. Number analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"(Week 0, week 54) and (week 0, week 80)","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"77"}]}],"classes":[{"title":"Week 54: Perceived frequency of hyperglycaemia","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"73"},{"groupId":"OG003","value":"72"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.6","spread":"1.9"},{"groupId":"OG001","value":"0.0","spread":"1.5"},{"groupId":"OG002","value":"0.0","spread":"1.9"},{"groupId":"OG003","value":"0.5","spread":"1.7"}]}]},{"title":"Week 80: Perceived frequency of hyperglycaemia","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.9","spread":"1.8"},{"groupId":"OG001","value":"0.5","spread":"1.8"},{"groupId":"OG002","value":"0.6","spread":"2.0"},{"groupId":"OG003","value":"0.7","spread":"1.9"}]}]},{"title":"Week 54: Perceived frequency of hypoglycaemia","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"73"},{"groupId":"OG003","value":"72"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.7","spread":"2.1"},{"groupId":"OG001","value":"-0.6","spread":"1.6"},{"groupId":"OG002","value":"-0.4","spread":"2.1"},{"groupId":"OG003","value":"-0.2","spread":"1.5"}]}]},{"title":"Week 80: Perceived frequency of hypoglycaemia","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.9","spread":"1.8"},{"groupId":"OG001","value":"-0.3","spread":"1.7"},{"groupId":"OG002","value":"-0.4","spread":"1.8"},{"groupId":"OG003","value":"-0.1","spread":"1.5"}]}]},{"title":"Week 54: Treatment satisfaction","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"73"},{"groupId":"OG003","value":"72"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.5","spread":"4.8"},{"groupId":"OG001","value":"0.9","spread":"5.2"},{"groupId":"OG002","value":"1.3","spread":"4.8"},{"groupId":"OG003","value":"0.2","spread":"5.5"}]}]},{"title":"Week 80: Treatment satisfaction","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"62"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.3","spread":"6.1"},{"groupId":"OG001","value":"1.2","spread":"5.7"},{"groupId":"OG002","value":"0.0","spread":"5.1"},{"groupId":"OG003","value":"0.2","spread":"6.2"}]}]}]},{"type":"SECONDARY","title":"Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 80 Relative to Baseline","description":"Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a mixed meal tolerance test (MMTT) stimulated C-peptide at week 80 is presented as ratio to baseline. AUC of C-peptide was measured as Nano moles\\*hour per liter (nmol\\*h/L).","populationDescription":"The FAS included all randomised participants. Overall number of participants analysed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of AUC","timeFrame":"0 - 4 hours post-dose on week 0 and week 80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"62"},{"groupId":"OG003","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.566","spread":"71.3"},{"groupId":"OG001","value":"0.598","spread":"70.2"},{"groupId":"OG002","value":"0.373","spread":"115.8"},{"groupId":"OG003","value":"0.571","spread":"100.9"}]}]}]},{"type":"SECONDARY","title":"AUC0-2h of C-peptide at Week 80 Relative to Baseline","description":"Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated C-peptide at week 80 is presented as ratio to baseline. AUC of C-peptide was measured as 'nmol\\*h/L'.","populationDescription":"The FAS included all randomised participants. Overall number of participants analysed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of AUC","timeFrame":"0-2 hours post-dose on week 0 and week 80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"62"},{"groupId":"OG003","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.590","spread":"74.5"},{"groupId":"OG001","value":"0.619","spread":"71.2"},{"groupId":"OG002","value":"0.370","spread":"111.5"},{"groupId":"OG003","value":"0.540","spread":"120.6"}]}]}]},{"type":"SECONDARY","title":"Cmax of C-peptide at Week 80 Relative to Baseline","description":"Maximum observed concentration (Cmax) of a MMTT stimulated C-peptide at week 80 is presented as ratio to baseline. Cmax of C-peptide was measured as nanomoles per liter (nmol/L).","populationDescription":"The FAS included all randomised participants. Overall number of participants analysed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of Cmax","timeFrame":"0-4 hours post-dose on week 0 and week 80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"62"},{"groupId":"OG003","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.580","spread":"74.8"},{"groupId":"OG001","value":"0.592","spread":"76.8"},{"groupId":"OG002","value":"0.389","spread":"109.0"},{"groupId":"OG003","value":"0.568","spread":"97.7"}]}]}]},{"type":"SECONDARY","title":"AUC0-4h of Glucose at Week 80 Relative to Baseline","description":"Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. AUC of glucose was measured as Milli moles\\*hour per liter (mmol\\*h/L).","populationDescription":"The FAS included all randomised participants. Overall number of participants analysed = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of AUC","timeFrame":"0 - 4 hours post-dose on week 0 and week 80","groups":[{"id":"OG000","title":"NNC0114-0006 + Liraglutide (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG001","title":"NNC0114-0006 (Experimental)","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG002","title":"Liraglutide (Experimental)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"63"},{"groupId":"OG003","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.129","spread":"33.3"},{"groupId":"OG001","value":"1.115","spread":"32.6"},{"groupId":"OG002","value":"1.136","spread":"39.0"},{"groupId":"OG003","value":"1.221","spread":"26.6"}]}]}]},{"type":"SECONDARY","title":"AUC0-2h of Glucose at Week 80 Relative to Baseline","description":"Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. AUC of glucose was measured as 'mmol\\*h/L'.","populationDescription":"The FAS included all randomised participants. 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Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"63"},{"groupId":"OG003","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.119","spread":"28.6"},{"groupId":"OG001","value":"1.086","spread":"28.1"},{"groupId":"OG002","value":"1.070","spread":"35.5"},{"groupId":"OG003","value":"1.166","spread":"21.7"}]}]}]},{"type":"SECONDARY","title":"Cmax of Glucose at Week 80 Relative to Baseline","description":"Maximum observed concentration (Cmax) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. Cmax of C-peptide was measured as 'mmol/L'.","populationDescription":"The FAS included all randomised participants. 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Participants continued their pre-trial insulin treatment throughout the trial."},{"id":"OG003","title":"Placebo (Placebo)","description":"Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"63"},{"groupId":"OG003","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.114","spread":"25.6"},{"groupId":"OG001","value":"1.074","spread":"28.7"},{"groupId":"OG002","value":"1.104","spread":"31.0"},{"groupId":"OG003","value":"1.155","spread":"21.5"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Weeks 0-80","description":"All reported adverse events are treatment-emergent. Results are based on the safety analysis set (SAS) which included all participants who received at least one dose of randomised treatment.","eventGroups":[{"id":"EG000","title":"NNC0114-0006 + Liraglutide","description":"Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. 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