{"protocolSection":{"identificationModule":{"nctId":"NCT03172494","orgStudyIdInfo":{"id":"NN9068-4148"},"secondaryIdInfos":[{"id":"U1111-1154-6671","type":"OTHER","domain":"World Health Organization (WHO)"},{"id":"CTR20170004","type":"REGISTRY","domain":"China Drug Trials (China)"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"A Trial Comparing Insulin Degludec/Liraglutide, Insulin Degludec, and Liraglutide in Chinese Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs)","officialTitle":"A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec, and Liraglutide in Chinese Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs)","acronym":"DUAL™ I China"},"statusModule":{"statusVerifiedDate":"2022-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2017-05-26","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2019-06-14","type":"ACTUAL"},"completionDateStruct":{"date":"2019-07-13","type":"ACTUAL"},"studyFirstSubmitDate":"2017-05-24","studyFirstSubmitQcDate":"2017-05-29","studyFirstPostDateStruct":{"date":"2017-06-01","type":"ACTUAL"},"resultsFirstSubmitDate":"2020-06-11","resultsFirstSubmitQcDate":"2020-06-11","resultsFirstPostDateStruct":{"date":"2020-07-07","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-11-18","lastUpdatePostDateStruct":{"date":"2022-12-14","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":true},"descriptionModule":{"briefSummary":"This trial is conducted in Asia. The aim of this trial is to confirm the efficacy of insulin degludec/liraglutide in controlling glycaemia in Chinese subjects with type 2 diabetes mellitus inadequately controlled on oral antidiabetic agents"},"conditionsModule":{"conditions":["Diabetes","Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":720,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Insulin degludec/liraglutide","type":"EXPERIMENTAL","interventionNames":["Drug: Insulin degludec/liraglutide"]},{"label":"Insulin degludec","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: Insulin degludec"]},{"label":"Liraglutide","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: Liraglutide"]}],"interventions":[{"type":"DRUG","name":"Insulin degludec/liraglutide","description":"Subcutaneously (s.c., under the skin)administration once daily in combination with metformin.\n\nFor 26 weeks.","armGroupLabels":["Insulin degludec/liraglutide"]},{"type":"DRUG","name":"Insulin degludec","description":"Subcutaneously (s.c., under the skin)administration once daily in combination with metformin.\n\nFor 26 weeks.","armGroupLabels":["Insulin degludec"]},{"type":"DRUG","name":"Liraglutide","description":"Subcutaneously (s.c., under the skin)administration once daily in combination with metformin.\n\nFor 26 weeks.","armGroupLabels":["Liraglutide"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in HbA1c","description":"Change in HbA1c from baseline (week 0) after 26 weeks of treatment is presented.","timeFrame":"Week 0, week 26"}],"secondaryOutcomes":[{"measure":"Change in Body Weight","description":"Change in body weight from baseline (week 0) after 26 weeks of treatment is presented.","timeFrame":"Week 0, week 26"},{"measure":"Number of Treatment Emergent Severe or BG Confirmed Hypoglycaemic Episodes","description":"Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or blood glucose (BG) confirmed by a plasma glucose (PG) value \\< 3.1 millimoles per liter (mmol/L) with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. The number of episodes are represented as rates. The observed rates of treatment-emergent severe or BG confirmed hypoglycaemic episodes per patient years of exposure (PYE) (number of episodes divided by PYE multiplied by 100) during 26 weeks of treatment are presented.","timeFrame":"Weeks 0-26"},{"measure":"Insulin Dose","description":"The actual daily total insulin dose after 26 weeks of treatment is presented. This outcome measure is only applicable for Insulin degludec/liraglutide and Insulin degludec treatment arms.","timeFrame":"Week 26"},{"measure":"Participants Who Achieved HbA1c < 7.0%, American Diabetes Association (ADA) Target (Yes/no)","description":"Number of participants who achieved ADA HbA1c target (HbA1c \\< 7.0%) (yes/no) after 26 weeks of treatment are presented.","timeFrame":"Week 26"},{"measure":"Participants Who Achieved HbA1c ≤ 6.5%, International Diabetes Federation (IDF) Target (Yes/no)","description":"Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) after 26 weeks of treatment are presented.","timeFrame":"Week 26"},{"measure":"Participants Who Achieved HbA1c <7.0% and Change in Body Weight From Baseline Below or Equal to Zero","description":"Number of participants who achieved ADA HbA1c target (HbA1c \\< 7.0%) (yes/no) and change from baseline in body weight below or equal to zero after 26 weeks are presented. Missing values are imputed by LOCF.","timeFrame":"Week 26"},{"measure":"Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero","description":"Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) and change from baseline in body weight below or equal to zero after 26 weeks are presented. Missing values are imputed by LOCF.","timeFrame":"Week 26"},{"measure":"Participants Who Achieved HbA1c < 7.0% Without Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes","description":"Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Number of participants who achieved ADA HbA1c target (HbA1c \\<7.0%) (yes/no) after 26 weeks of treatment and without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment are presented. Missing values are imputed by LOCF.","timeFrame":"Week 26"},{"measure":"Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Hypoglycaemic Episodes","description":"Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \\< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) after 26 weeks of treatment and without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment are presented. Missing values are imputed by LOCF.","timeFrame":"Week 26"},{"measure":"Participants Who Achieved HbA1c < 7.0% Without Severe or BG Confirmed Episodes, and Change From Baseline in Body Weight Below or Equal to Zero.","description":"Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \\< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Number of participants who achieved ADA HbA1c target (HbA1c \\< 7.0%) (yes/no) after 26 weeks of treatment without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment and with change from baseline in body weight below or equal to zero are presented. Missing values are imputed by LOCF.","timeFrame":"Week 26"},{"measure":"Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Episodes and Change From Baseline in Body Weight Below or Equal to Zero.","description":"Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \\< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) after 26 weeks of treatment without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment and with change from baseline in body weight below or equal to zero are presented. Missing values are imputed by LOCF.","timeFrame":"Week 26"},{"measure":"Change in Fasting Plasma Glucose (FPG)","description":"Change from baseline (week 0) in FPG after 26 weeks of treatment is presented.","timeFrame":"Week 0, week 26"},{"measure":"Change in Waist Circumferance","description":"Change from baseline (week 0) in waist circumferance after 26 weeks of treatment is presented.","timeFrame":"Week 0, week 26"},{"measure":"9-point SMPG Profile","description":"Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). 9-point SMPG values at 26 weeks of treatment are presented.","timeFrame":"Week 26"},{"measure":"Change in Mean of 9-point SMPG Profile","description":"Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). The mean of profile is defined as the area under the profile divided by measurement time and is calculated using the trapezoidal method. Change in mean of the 9-point SMPG profile from baseline (week 0) to week 26 is presented.","timeFrame":"Week 0, week 26"},{"measure":"Change in Mean Post-prandial Plasma Glucose (PG) Increments","description":"Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). Post-prandial SMPG increments from before meal to 90 minutes after for breakfast, lunch and dinner were calculated. The mean increment over all meals was derived as the mean of all available meal increments. Change from baseline (week 0) in post-prandial SMPG increments for all meals after 26 weeks of treatment is presented.","timeFrame":"Week 0, week 26"},{"measure":"Change in Fasting C-peptide - Ratio to Baseline","description":"Change in fasting C-peptide (measured in nanomoles per liter \\[nmol/L\\]) from baseline (week 0) to week 26 is presented as ratio to baseline.","timeFrame":"Week 0, week 26"},{"measure":"Change in Fasting Human Insulin - Ratio to Baseline","description":"Change in fasting human insulin (measured in picomoles per liter \\[pmol/L\\]) from baseline (week 0) to week 26 is presented as ratio to baseline.","timeFrame":"Week 0, week 26"},{"measure":"Change in Fasting Glucagon - Ratio to Baseline","description":"Change in fasting glucagon (measured in picograms per milliliter \\[pg/mL\\]) from baseline (week 0) to week 26 is presented as ratio to baseline.","timeFrame":"Week 0, week 26"},{"measure":"Change in HOMA-B (Beta Cell Function)- Ratio to Baseline","description":"Change in HOMA-B (measured in %) from baseline (week 0) to week 26 is presented as ratio to baseline.","timeFrame":"Week 0, week 26"},{"measure":"Change in Fasting Total Cholesterol - Ratio to Baseline","description":"Change in fasting total cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.","timeFrame":"Week 0, week 26"},{"measure":"Change in Fasting High Density Lipoprotein (HDL) Cholesterol- Ratio to Baseline","description":"Change in fasting HDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline","timeFrame":"Week 0, week 26"},{"measure":"Change in Fasting Low Density Lipoprotein (LDL) Cholesterol- Ratio to Baseline","description":"Change in fasting LDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.","timeFrame":"Week 0, week 26"},{"measure":"Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline","description":"Change in fasting VLDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline","timeFrame":"Week 0, week 26"},{"measure":"Change in Fasting Triglycerides - Ratio to Baseline.","description":"Change in fasting triglycerides (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.","timeFrame":"Week 0, week 26"},{"measure":"Change in Fasting Free Fatty Acid - Ratio to Baseline","description":"Change in fasting free fatty acid (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.","timeFrame":"Week 0, week 26"},{"measure":"Number of Treatment-emergent Adverse Events (TEAE)","description":"A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. The observed rates of adverse events (AEs) per patient years of exposure (PYE) (number of AEs divided by PYE multiplied by 100) after 26 weeks are presented.","timeFrame":"Weeks 0-26"},{"measure":"Number of Treatment Emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes.","description":"Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \\< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as nocturnal if the time of the onset was between 00:01 and 05.59 both inclusive. The number of episodes are represented as rates. The observed rates of episodes per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented.","timeFrame":"Weeks 0-26"},{"measure":"Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes.","description":"Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \\<3.1 mmol/L with symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. The number of episodes are represented as rates. The observed rates of episodes per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented.","timeFrame":"Weeks 0-26"},{"measure":"Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes","description":"Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \\<3.1 mmol/L with symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as nocturnal if the time of the onset was between 00:01 and 05.59 both inclusive. The number of episodes are represented as rates. The observed rates of episodes per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented.","timeFrame":"Weeks 0-26"},{"measure":"Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition","description":"A hypoglycaemic episode was 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 7 days after the last day on trial product. The number of episodes are represented as rates. The observed rates of episodes (according to the ADA definition) per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented.","timeFrame":"Weeks 0-26"},{"measure":"Change in Physical Examination","description":"Physical examination parameters are categorised as cardiovascular system; central and peripheral nervous system; gastrointestinal system including mouth; general appearance; head, ears, eyes, nose, throat, neck; lymph node palpation; musculoskeletal system; respiratory system; skin and thyroid gland. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at screening (week -2) and week 26 per each category is presented.","timeFrame":"Week -2, week 26"},{"measure":"Eye Examination","description":"Dilated fundoscopy or fundus photography was performed by the investigator at screening (week -2) and week 26. The results of the examination were interpreted for each eye (left and right) and are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at screening (week -2) and week 26 is presented.","timeFrame":"Week -2, Week 26"},{"measure":"Change in Electrocardiogram (ECG)","description":"Electrocardiogram was assessed by the investigator as normal, abnormal NCS and abnormal CS. Number of participants at screening (week -2) and at week 26 is presented.","timeFrame":"Week -2, week 26"},{"measure":"Change in Pulse","description":"Change in pulse from baseline (week 0) after 26 weeks of treatment is presented","timeFrame":"Week 0, week 26"},{"measure":"Change in Blood Pressure (Systolic and Diastolic Blood Pressure)","description":"Change in blood pressure (systolic and diastolic blood pressure) from baseline (week 0) after 26 weeks of treatment is presented","timeFrame":"Week 0, week 26"},{"measure":"Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum","description":"Change in alkaline phosphatase, ALT, AST, creatine kinase, amylase, lipase, creatine kinase serum from baseline (week 0) after 26 weeks of treatment is presented.","timeFrame":"Week 0, week 26"},{"measure":"Change in Biochemistry Parameters (Albumin Serum, Total Protein)","description":"Change in total protein, albumin serum from baseline (week 0) after 26 weeks of treatment is presented.","timeFrame":"Week 0, week 26"},{"measure":"Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum","description":"Change in calcium serum (total), calcium corrected serum, potassium serum, sodium serum, urea serum from baseline (week 0) after 26 weeks of treatment is presented.","timeFrame":"Week 0, week 26"},{"measure":"Change in Biochemistry Parameters: Total Bilirubin Serum, Creatinine Serum","description":"Change in total bilirubin serum, creatinine serum from baseline (week 0) after 26 weeks of treatment is presented.","timeFrame":"Week 0, week 26"},{"measure":"Change in Haematological Parameter: Erythrocytes Blood","description":"Change in erythrocyte blood from baseline (week 0) after 26 weeks of treatment is presented.","timeFrame":"Week 0, week 26"},{"measure":"Change in Haematological Parameter: Haematocrits","description":"Change in haematocrits from baseline (week 0) after 26 weeks of treatment is presented.","timeFrame":"Week 0, week 26"},{"measure":"Change in Haemotological Parameter- Eosinophils","description":"Change in eosinophils from baseline after 26 weeks of treatment is presented.","timeFrame":"Week 0, week 26"},{"measure":"Change in Haematological Parameter - Neutrophils","description":"Change in neutrophils from baseline (week 0) after 26 weeks of treatment is presented.","timeFrame":"Week 0, week 26"},{"measure":"Change in Haematological Parameter: Basophils","description":"Change in basophils from baseline (week 0) after 26 weeks of treatment is presented.","timeFrame":"Week 0, week 26"},{"measure":"Change in Haemotological Parameter- Monocytes","description":"Change in monocytes from baseline (week 0) after 26 weeks of treatment is presented","timeFrame":"Week 0, week 26"},{"measure":"Change in Haematological Parameter - Lymphocytes","description":"Change in lymphocytes from baseline (week 0) after 26 weeks of treatment is presented","timeFrame":"Week 0, week 26"},{"measure":"Change in Haematology: Haemoglobin Blood","description":"Change in haemoglobin from baseline (week 0) after 26 weeks of treatment is presented.","timeFrame":"Week 0, week 26"},{"measure":"Change in Haematologcal Parameter: Leukocytes","description":"Change in leukocytes from baseline (week 0) after 26 weeks of treatment","timeFrame":"Week 0, week 26"},{"measure":"Change in Haematological Parameter: Thrombocytes","description":"Change in thrombocytes from baseline (week 0) after 26 weeks of treatment","timeFrame":"Week 0, week 26"},{"measure":"Change in Calcitonin","description":"Calcitonin levels were measured and were categorised as low, normal or high in relation to reference range (8.31- 14.3 picogram/milliliter \\[pg/mL\\]). Number of participants in each category at baseline (week 0) and week 26 are presented.","timeFrame":"Week 0, week 26"},{"measure":"Urinalysis (Protein, Glucose, Erythrocytes and Ketones)","description":"The urinalysis assessment was the measurements of protein, glucose, erythrocytes and ketones in urine at baseline (week 0) and week 26 and categorised as negative, trace and positive. Number of participants in each category at week 0 and week 26 is presented.","timeFrame":"Week 0, week 26"},{"measure":"Occurence of Anti-insulin Degludec Specific Antibodies","description":"This outcome measure is only applicable for the insulin degludec/liraglutide arm and insulin degludec arm. Serum samples were analysed for the presence of anti-insulin degludec specific antibodies. Results at week 27 are presented as percentage of bound radioactive-labelled insulin (B) /total radioactive-labelled insulin added to the samples (T).","timeFrame":"Week 27"},{"measure":"Occurence of Antibodies Cross-reacting to Human Insulin","description":"This outcome measure is only applicable for the insulin degludec/liraglutide arm and insulin degludec arm. Serum samples were analysed for the presence of cross-reacting antibodies to human insulin. Results at week 27 are presented as percentage of bound radioactive-labelled insulin (B) /total radioactive-labelled insulin added to the samples (T).","timeFrame":"Week 27"},{"measure":"Occurence of Total Insulin Antibodies","description":"This outcome measure is only applicable for the Insulin degludec/liraglutide arm and Insulin degludec arm. Serum samples were analysed for the presence of antobodies to human insulin. Results at week 27 are presented as percentage of bound radioactive-labelled insulin (B) /total radioactive-labelled insulin added to the samples (T).","timeFrame":"Week 27"},{"measure":"Occurence of Anti-liraglutide Antibodies","description":"This outcome measure is applicable for the Insulin degludec/liraglutide arm and the liraglutide arm. Serum samples were analysed for the presence of anti-liraglutide antibodies. Number of participants who were assessed for anti-liraglutide antibodies at week 27 are presented.","timeFrame":"Week 27"},{"measure":"Occurence of Antibodies Cross-reacting to Native Glucagon-like Peptide (GLP-1)","description":"This outcome measure is applicable to the Insulin degludec/liraglutide arm and the liraglutide arm. Serum samples were analysed for the presence of cross-reacting antibodies to native GLP-1. Number of participants who measured with anti-liraglutide antibodies cross reacting native GLP-1 at week 27 are presented.","timeFrame":"Week 27"},{"measure":"Occurence of Neutralising Liraglutide Antibodies","description":"This outcome measure is only applicable for the Insulin degludec/liraglutide arm and liraglutide arm. Neutralising antibodies were assessed when the corresponding anti-Liraglutide antibody were positive at week 27. Number of participants who measured with neutralising liraglutide antibodies at week 27 are presented.","timeFrame":"Week 27"},{"measure":"Occurence of Neutralising Antibodies Cross-reacting to Native GLP-1","description":"This outcome measure is only applicable for the Insulin degludec/liraglutide arm and liraglutide arm. Cross reacting antibodies were assessed when anti-liraglutide antibody was positive. Number of participants who measured with neutralising liraglutide antibodies cross-reacting to native GLP-1 at week 27 are presented.","timeFrame":"Week 27"},{"measure":"Serum Concentrations of Insulin Degludec","description":"This outcome measure is applicable for Insulin degludec and Insulin degludec/liraglutide arms. Serum samples from the Insulin degludec/liraglutide and Insulin degludec arms were assayed using population PK analysis. The maximum serum concentrations (Cmax) are summarised for the two arms.","timeFrame":"Week 0, week 26"},{"measure":"Plasma Concentration of Liraglutide","description":"This outcome measure is for Insulin degludec/liraglutide and liraglutide arms. Serum samples from the Insulin degludec/liraglutide and liraglutide arms were assayed using population PK analysis. The Cmax are summarised for the two arms.","timeFrame":"Week 0, week 26"}]},"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* Type 2 diabetes mellitus (clinically diagnosed)\n* Male or female, age at least 18 years at the time of signing informed consent\n* HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis, with the aim of a median of8.3%. When approximately 50% of the randomised subjects have an HbA1c above 8.3%, the remaining subjects randomised must have an HbA1c below or equal to 8.3%; or when approximately 50% of the randomised subjects have an HbA1c below or equal to 8.3%, the remaining subjects randomised must have an HbA1c above 8.3%\n* Current treatment for at least 90 calendar days prior to screening with metformin plus/minus one other OAD: α-glucosidase inhibitors, sulphonylureas, glinides or thiazolidinediones. For above or equal to 60 calendar days prior to screening subjects should be on a stable dose of:\n* Metformin (above or equal to 1500 mg or max tolerated dose) or\n* Metformin (above or equal to 1500 mg or max tolerated dose) and sulphonylureas (above or equal to half of the max approved dose according to local label) or\n* Metformin (above or equal to 1500 mg or max tolerated dose) and glinides (above or equal to half of the max approved dose according to local label) or\n* Metformin (above or equal to 1500 mg or max tolerated dose) and α-glucosidase inhibitors (above or equal to half of the max approved dose according to local label) or\n* Metformin (above or equal to 1500 mg or max tolerated dose) and thiazolidinediones (above or equal to half of the max approved dose according to local label)\n\nExclusion Criteria:\n\n* Treatment with insulin (except for short-term treatment at the discretion of the investigator)\n* Treatment with glucagon-like-peptide-1 receptor agonists or dipeptidyl-peptidase-4 inhibitors within 90 days prior to screening\n* Impaired liver function, defined as alanine aminotransferase above or equal to 2.5 times upper normal range\n* Impaired renal function defined as serum-creatinine above or equal to 133 μmol/L for males and above or equal to 125 μmol/L for females, or as defined according to local contraindications for metformin\n* Screening calcitonin above or equal to 50 ng/L\n* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)\n* Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 12 months prior to screening and/or planned coronary, carotid or peripheral artery revascularisation procedures\n* Severe uncontrolled treated or untreated hypertension (systolic blood pressure above or equal to 180 mmHg or diastolic blood pressure above or equal to 100 mmHg\n* Proliferative retinopathy or maculopathy (macular oedema), requiring acute treatment\n* History of pancreatitis (acute or chronic)","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Global Clinical Registry (GCR,1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Novo Nordisk Investigational Site","city":"Hefei","state":"Anhui","zip":"230061","country":"China","geoPoint":{"lat":31.86389,"lon":117.28083}},{"facility":"Novo Nordisk Investigational Site","city":"Beijing","state":"Beijing Municipality","zip":"100071","country":"China","geoPoint":{"lat":39.9075,"lon":116.39723}},{"facility":"Novo Nordisk Investigational Site","city":"Beijing","state":"Beijing Municipality","zip":"101200","country":"China","geoPoint":{"lat":39.9075,"lon":116.39723}},{"facility":"Novo Nordisk Investigational Site","city":"Chongqing","state":"Chongqing Municipality","zip":"404000","country":"China","geoPoint":{"lat":29.56026,"lon":106.55771}},{"facility":"Novo Nordisk Investigational Site","city":"Fuzhou","state":"Fujian","zip":"350001","country":"China","geoPoint":{"lat":26.06139,"lon":119.30611}},{"facility":"Novo Nordisk Investigational Site","city":"Fuzhou","state":"Fujian","zip":"350025","country":"China","geoPoint":{"lat":26.06139,"lon":119.30611}},{"facility":"Novo Nordisk Investigational Site","city":"Guangzhou","state":"Guangdong","zip":"510080","country":"China","geoPoint":{"lat":23.11667,"lon":113.25}},{"facility":"Novo Nordisk Investigational Site","city":"Guangzhou","state":"Guangdong","zip":"510120","country":"China","geoPoint":{"lat":23.11667,"lon":113.25}},{"facility":"Novo Nordisk Investigational Site","city":"Guangzhou","state":"Guangdong","zip":"510515","country":"China","geoPoint":{"lat":23.11667,"lon":113.25}},{"facility":"Novo Nordisk Investigational 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DUAL I China: Improved glycemic control with IDegLira versus its individual components in a randomized trial with Chinese participants with type 2 diabetes uncontrolled on oral antidiabetic drugs. J Diabetes. 2022 Jun;14(6):401-413. doi: 10.1111/1753-0407.13286."}]},"ipdSharingStatementModule":{"ipdSharing":"YES"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants were randomised in a 2:1:1 manner to receive insulin degludec/liraglutide, insulin degludec or liraglutide in combination with metformin.","recruitmentDetails":"The trial was conducted at 38 sites in China mainland.","groups":[{"id":"FG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 milligrams (mg) liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 millimoles/litre (mmol/L). The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"FG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"FG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg per day (mg/day) was continued for the remaining period of treatment.\""}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"361"},{"groupId":"FG001","numSubjects":"179"},{"groupId":"FG002","numSubjects":"180"}]},{"type":"Full Analysis Set (FAS)","achievements":[{"groupId":"FG000","numSubjects":"361"},{"groupId":"FG001","numSubjects":"179"},{"groupId":"FG002","numSubjects":"180"}]},{"type":"Safety Analysis Set (SAS)","achievements":[{"groupId":"FG000","numSubjects":"358"},{"groupId":"FG001","numSubjects":"175"},{"groupId":"FG002","numSubjects":"180"}]},{"type":"Exposed","achievements":[{"groupId":"FG000","numSubjects":"358"},{"groupId":"FG001","numSubjects":"175"},{"groupId":"FG002","numSubjects":"180"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"341"},{"groupId":"FG001","numSubjects":"167"},{"groupId":"FG002","numSubjects":"151"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"12"},{"groupId":"FG002","numSubjects":"29"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"15"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"4"}]},{"type":"Pregnancy","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"8"}]},{"type":"Severe hypoglycaemic episode","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Non-compliance towards treatment","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"FAS included all randomised participants.","groups":[{"id":"BG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"BG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"BG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"361"},{"groupId":"BG001","value":"179"},{"groupId":"BG002","value":"180"},{"groupId":"BG003","value":"720"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"54.5","spread":"10.3"},{"groupId":"BG001","value":"55.7","spread":"10.2"},{"groupId":"BG002","value":"54.1","spread":"10.2"},{"groupId":"BG003","value":"54.7","spread":"10.3"}]}]}]},{"title":"Sex/Gender, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"142"},{"groupId":"BG001","value":"79"},{"groupId":"BG002","value":"72"},{"groupId":"BG003","value":"293"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"219"},{"groupId":"BG001","value":"100"},{"groupId":"BG002","value":"108"},{"groupId":"BG003","value":"427"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"361"},{"groupId":"BG001","value":"179"},{"groupId":"BG002","value":"180"},{"groupId":"BG003","value":"720"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","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"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"361"},{"groupId":"BG001","value":"179"},{"groupId":"BG002","value":"180"},{"groupId":"BG003","value":"720"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Glycosylated haemoglobin (HbA1c)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Percentage points of HbA1c","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.20","spread":"0.83"},{"groupId":"BG001","value":"8.31","spread":"0.84"},{"groupId":"BG002","value":"8.21","spread":"0.77"},{"groupId":"BG003","value":"8.23","spread":"0.82"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in HbA1c","description":"Change in HbA1c from baseline (week 0) after 26 weeks of treatment is presented.","populationDescription":"FAS included all randomised participants. Overall number of participants analysed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage points of HbA1c","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.71","spread":"0.88"},{"groupId":"OG001","value":"-1.20","spread":"0.99"},{"groupId":"OG002","value":"-1.16","spread":"0.89"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The change from baseline in HbA1c after 26 weeks of treatment was analysed using an analysis of covariance (ANCOVA) model with treatment and previous oral anti-diabetic (OAD) treatment as fixed factors and baseline HbA1c as covariate. Missing values were imputed by last observation carried forward (LOCF).","nonInferiorityType":"NON_INFERIORITY","nonInferiorityComment":"Non-inferiority of insulin degludec/liraglutide versus insulin degludec was considered as confirmed if the 95% confidence interval (CI) for the mean treatment difference lied entirely below 0.4%. Non-inferiority was investigated on the FAS.","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"Mean treatment difference","paramValue":"-0.59","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.73","ciUpperLimit":"-0.46"},{"groupIds":["OG000","OG002"],"groupDescription":"The change from baseline in HbA1c after 26 weeks of treatment was analysed using an ANCOVA model with treatment and previous OAD treatment as fixed factors and baseline HbA1c as covariate. Missing values were imputed by LOCF.","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"Mean treatment difference","paramValue":"-0.63","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.76","ciUpperLimit":"-0.49"}]},{"type":"SECONDARY","title":"Change in Body Weight","description":"Change in body weight from baseline (week 0) after 26 weeks of treatment is presented.","populationDescription":"FAS included all randomised participants. Overall number of participants analysed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilogram (Kg)","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.2","spread":"2.7"},{"groupId":"OG001","value":"1.3","spread":"2.7"},{"groupId":"OG002","value":"-2.5","spread":"2.7"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment Emergent Severe or BG Confirmed Hypoglycaemic Episodes","description":"Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or blood glucose (BG) confirmed by a plasma glucose (PG) value \\< 3.1 millimoles per liter (mmol/L) with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. The number of episodes are represented as rates. The observed rates of treatment-emergent severe or BG confirmed hypoglycaemic episodes per patient years of exposure (PYE) (number of episodes divided by PYE multiplied by 100) during 26 weeks of treatment are presented.","populationDescription":"Safety analysis set (SAS) included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"(Number of episodes/PYE)*100","timeFrame":"Weeks 0-26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"3"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"23.94"},{"groupId":"OG001","value":"17.01"},{"groupId":"OG002","value":"3.60"}]}]}]},{"type":"SECONDARY","title":"Insulin Dose","description":"The actual daily total insulin dose after 26 weeks of treatment is presented. This outcome measure is only applicable for Insulin degludec/liraglutide and Insulin degludec treatment arms.","populationDescription":"SAS included all participants receiving at least one dose of the insulin degludec/liraglutide or insulin degludec. Overall number of participants analysed = participants with available data","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units of insulin (U)","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"340"},{"groupId":"OG001","value":"167"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"24.8","spread":"11.9"},{"groupId":"OG001","value":"30.1","spread":"14.4"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved HbA1c < 7.0%, American Diabetes Association (ADA) Target (Yes/no)","description":"Number of participants who achieved ADA HbA1c target (HbA1c \\< 7.0%) (yes/no) after 26 weeks of treatment are presented.","populationDescription":"FAS included all randomised participants. Overall number of participants analysied = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"272"},{"groupId":"OG001","value":"83"},{"groupId":"OG002","value":"80"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"69"},{"groupId":"OG001","value":"84"},{"groupId":"OG002","value":"71"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved HbA1c ≤ 6.5%, International Diabetes Federation (IDF) Target (Yes/no)","description":"Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) after 26 weeks of treatment are presented.","populationDescription":"FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"201"},{"groupId":"OG001","value":"48"},{"groupId":"OG002","value":"41"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"140"},{"groupId":"OG001","value":"119"},{"groupId":"OG002","value":"110"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved HbA1c <7.0% and Change in Body Weight From Baseline Below or Equal to Zero","description":"Number of participants who achieved ADA HbA1c target (HbA1c \\< 7.0%) (yes/no) and change from baseline in body weight below or equal to zero after 26 weeks are presented. Missing values are imputed by LOCF.","populationDescription":"FAS included all randomised participants.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"361"},{"groupId":"OG001","value":"179"},{"groupId":"OG002","value":"180"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"147"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"74"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"214"},{"groupId":"OG001","value":"145"},{"groupId":"OG002","value":"106"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero","description":"Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) and change from baseline in body weight below or equal to zero after 26 weeks are presented. Missing values are imputed by LOCF.","populationDescription":"FAS included all randomised participants.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"361"},{"groupId":"OG001","value":"179"},{"groupId":"OG002","value":"180"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"111"},{"groupId":"OG001","value":"21"},{"groupId":"OG002","value":"37"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"250"},{"groupId":"OG001","value":"158"},{"groupId":"OG002","value":"143"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved HbA1c < 7.0% Without Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes","description":"Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Number of participants who achieved ADA HbA1c target (HbA1c \\<7.0%) (yes/no) after 26 weeks of treatment and without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment are presented. Missing values are imputed by LOCF.","populationDescription":"FAS included all randomised participants.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"361"},{"groupId":"OG001","value":"179"},{"groupId":"OG002","value":"180"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"265"},{"groupId":"OG001","value":"80"},{"groupId":"OG002","value":"84"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"96"},{"groupId":"OG001","value":"99"},{"groupId":"OG002","value":"96"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Hypoglycaemic Episodes","description":"Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \\< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) after 26 weeks of treatment and without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment are presented. Missing values are imputed by LOCF.","populationDescription":"FAS included all randomised participants.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"361"},{"groupId":"OG001","value":"179"},{"groupId":"OG002","value":"180"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"195"},{"groupId":"OG001","value":"46"},{"groupId":"OG002","value":"43"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"166"},{"groupId":"OG001","value":"133"},{"groupId":"OG002","value":"137"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved HbA1c < 7.0% Without Severe or BG Confirmed Episodes, and Change From Baseline in Body Weight Below or Equal to Zero.","description":"Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \\< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Number of participants who achieved ADA HbA1c target (HbA1c \\< 7.0%) (yes/no) after 26 weeks of treatment without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment and with change from baseline in body weight below or equal to zero are presented. Missing values are imputed by LOCF.","populationDescription":"FAS included all randomised participants.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"361"},{"groupId":"OG001","value":"179"},{"groupId":"OG002","value":"180"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"136"},{"groupId":"OG001","value":"33"},{"groupId":"OG002","value":"72"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"225"},{"groupId":"OG001","value":"146"},{"groupId":"OG002","value":"108"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Episodes and Change From Baseline in Body Weight Below or Equal to Zero.","description":"Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \\< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) after 26 weeks of treatment without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment and with change from baseline in body weight below or equal to zero are presented. Missing values are imputed by LOCF.","populationDescription":"FAS included all randomised participants.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"361"},{"groupId":"OG001","value":"179"},{"groupId":"OG002","value":"180"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"103"},{"groupId":"OG001","value":"21"},{"groupId":"OG002","value":"36"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"258"},{"groupId":"OG001","value":"158"},{"groupId":"OG002","value":"144"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose (FPG)","description":"Change from baseline (week 0) in FPG after 26 weeks of treatment is presented.","populationDescription":"FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"150"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.64","spread":"2.27"},{"groupId":"OG001","value":"-3.45","spread":"2.34"},{"groupId":"OG002","value":"-1.86","spread":"2.11"}]}]}]},{"type":"SECONDARY","title":"Change in Waist Circumferance","description":"Change from baseline (week 0) in waist circumferance after 26 weeks of treatment is presented.","populationDescription":"FAS included all randomised participants. Overall number of participants analysed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Centimeters (cm)","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"166"},{"groupId":"OG002","value":"151"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.3","spread":"3.4"},{"groupId":"OG001","value":"1.2","spread":"4.2"},{"groupId":"OG002","value":"-2.6","spread":"3.8"}]}]}]},{"type":"SECONDARY","title":"9-point SMPG Profile","description":"Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). 9-point SMPG values at 26 weeks of treatment are presented.","populationDescription":"FAS included all randomised participants. Number analysed= number of participants with available data","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"361"},{"groupId":"OG001","value":"179"},{"groupId":"OG002","value":"180"}]}],"classes":[{"title":"Before breakfast","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"337"},{"groupId":"OG001","value":"165"},{"groupId":"OG002","value":"151"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.41","spread":"1.07"},{"groupId":"OG001","value":"5.66","spread":"1.20"},{"groupId":"OG002","value":"6.89","spread":"1.37"}]}]},{"title":"90 minutes after the start of breakfast","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"336"},{"groupId":"OG001","value":"161"},{"groupId":"OG002","value":"151"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"8.97","spread":"2.48"},{"groupId":"OG001","value":"9.85","spread":"2.73"},{"groupId":"OG002","value":"10.04","spread":"2.81"}]}]},{"title":"Before lunch","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"334"},{"groupId":"OG001","value":"162"},{"groupId":"OG002","value":"151"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6.31","spread":"1.80"},{"groupId":"OG001","value":"7.10","spread":"2.35"},{"groupId":"OG002","value":"7.48","spread":"2.14"}]}]},{"title":"90 minutes after the start of the lunch","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"334"},{"groupId":"OG001","value":"161"},{"groupId":"OG002","value":"151"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"8.87","spread":"2.15"},{"groupId":"OG001","value":"10.18","spread":"2.81"},{"groupId":"OG002","value":"9.54","spread":"2.43"}]}]},{"title":"Before dinner","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"335"},{"groupId":"OG001","value":"164"},{"groupId":"OG002","value":"151"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6.52","spread":"1.77"},{"groupId":"OG001","value":"7.39","spread":"2.23"},{"groupId":"OG002","value":"7.50","spread":"2.11"}]}]},{"title":"90 minutes after start of the dinner","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"332"},{"groupId":"OG001","value":"164"},{"groupId":"OG002","value":"151"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"9.33","spread":"2.40"},{"groupId":"OG001","value":"10.27","spread":"2.68"},{"groupId":"OG002","value":"9.45","spread":"2.13"}]}]},{"title":"At bedtime","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"330"},{"groupId":"OG001","value":"160"},{"groupId":"OG002","value":"150"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"7.99","spread":"2.28"},{"groupId":"OG001","value":"8.86","spread":"2.38"},{"groupId":"OG002","value":"8.49","spread":"2.26"}]}]},{"title":"At 4:00 am","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"158"},{"groupId":"OG002","value":"148"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.60","spread":"1.26"},{"groupId":"OG001","value":"6.12","spread":"1.75"},{"groupId":"OG002","value":"6.86","spread":"1.60"}]}]},{"title":"Before breakfast the following day","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"336"},{"groupId":"OG001","value":"165"},{"groupId":"OG002","value":"150"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.35","spread":"0.96"},{"groupId":"OG001","value":"5.47","spread":"1.07"},{"groupId":"OG002","value":"6.81","spread":"1.47"}]}]}]},{"type":"SECONDARY","title":"Change in Mean of 9-point SMPG Profile","description":"Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). The mean of profile is defined as the area under the profile divided by measurement time and is calculated using the trapezoidal method. Change in mean of the 9-point SMPG profile from baseline (week 0) to week 26 is presented.","populationDescription":"FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"331"},{"groupId":"OG001","value":"162"},{"groupId":"OG002","value":"146"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.17","spread":"2.16"},{"groupId":"OG001","value":"-2.47","spread":"2.14"},{"groupId":"OG002","value":"-2.13","spread":"2.02"}]}]}]},{"type":"SECONDARY","title":"Change in Mean Post-prandial Plasma Glucose (PG) Increments","description":"Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). Post-prandial SMPG increments from before meal to 90 minutes after for breakfast, lunch and dinner were calculated. The mean increment over all meals was derived as the mean of all available meal increments. Change from baseline (week 0) in post-prandial SMPG increments for all meals after 26 weeks of treatment is presented.","populationDescription":"FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"335"},{"groupId":"OG001","value":"164"},{"groupId":"OG002","value":"150"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.20","spread":"2.40"},{"groupId":"OG001","value":"0.09","spread":"2.40"},{"groupId":"OG002","value":"-0.54","spread":"2.57"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting C-peptide - Ratio to Baseline","description":"Change in fasting C-peptide (measured in nanomoles per liter \\[nmol/L\\]) from baseline (week 0) to week 26 is presented as ratio to baseline.","populationDescription":"FAS included all randomised participants. Overall, number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of fasting C-peptide","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"339"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"150"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.54","spread":"52.8"},{"groupId":"OG001","value":"0.38","spread":"68.5"},{"groupId":"OG002","value":"0.98","spread":"37.6"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Human Insulin - Ratio to Baseline","description":"Change in fasting human insulin (measured in picomoles per liter \\[pmol/L\\]) from baseline (week 0) to week 26 is presented as ratio to baseline.","populationDescription":"FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of fasting human insulin","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"328"},{"groupId":"OG001","value":"162"},{"groupId":"OG002","value":"142"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.53","spread":"71.7"},{"groupId":"OG001","value":"0.38","spread":"77.6"},{"groupId":"OG002","value":"1.04","spread":"53.3"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Glucagon - Ratio to Baseline","description":"Change in fasting glucagon (measured in picograms per milliliter \\[pg/mL\\]) from baseline (week 0) to week 26 is presented as ratio to baseline.","populationDescription":"FAS included all randomised participants. Overall number of particiapants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of fasting glucagon","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"338"},{"groupId":"OG001","value":"165"},{"groupId":"OG002","value":"150"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.90","spread":"76.6"},{"groupId":"OG001","value":"0.95","spread":"56.4"},{"groupId":"OG002","value":"0.98","spread":"75.9"}]}]}]},{"type":"SECONDARY","title":"Change in HOMA-B (Beta Cell Function)- Ratio to Baseline","description":"Change in HOMA-B (measured in %) from baseline (week 0) to week 26 is presented as ratio to baseline.","populationDescription":"FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of HOMA-B (beta cell function)","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"328"},{"groupId":"OG001","value":"162"},{"groupId":"OG002","value":"141"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.38","spread":"77.3"},{"groupId":"OG001","value":"0.94","spread":"77.4"},{"groupId":"OG002","value":"1.53","spread":"63.8"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Total Cholesterol - Ratio to Baseline","description":"Change in fasting total cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.","populationDescription":"FAS included all randomised participants. Overall number of participants analysed = number of participants with available data","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of fasting total cholesterol","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.94","spread":"19.1"},{"groupId":"OG001","value":"0.99","spread":"16.8"},{"groupId":"OG002","value":"0.97","spread":"17.7"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting High Density Lipoprotein (HDL) Cholesterol- Ratio to Baseline","description":"Change in fasting HDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline","populationDescription":"FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of fasting HDL cholesterol","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.01","spread":"14.7"},{"groupId":"OG001","value":"1.02","spread":"15.7"},{"groupId":"OG002","value":"1.03","spread":"14.8"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Low Density Lipoprotein (LDL) Cholesterol- Ratio to Baseline","description":"Change in fasting LDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.","populationDescription":"FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of fasting LDL cholesterol","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"340"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.92","spread":"34.2"},{"groupId":"OG001","value":"1.01","spread":"36.2"},{"groupId":"OG002","value":"0.96","spread":"34.4"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline","description":"Change in fasting VLDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline","populationDescription":"FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of fasting VLDL cholesterol","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.90","spread":"49.9"},{"groupId":"OG001","value":"0.84","spread":"47.2"},{"groupId":"OG002","value":"0.92","spread":"38.6"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Triglycerides - Ratio to Baseline.","description":"Change in fasting triglycerides (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.","populationDescription":"FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of fasting triglycerides","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.88","spread":"54.4"},{"groupId":"OG001","value":"0.82","spread":"50.5"},{"groupId":"OG002","value":"0.90","spread":"45.2"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Free Fatty Acid - Ratio to Baseline","description":"Change in fasting free fatty acid (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.","populationDescription":"FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of fasting free fatty acid","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"340"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"150"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.55","spread":"69.9"},{"groupId":"OG001","value":"0.48","spread":"76.5"},{"groupId":"OG002","value":"0.80","spread":"69.3"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment-emergent Adverse Events (TEAE)","description":"A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. The observed rates of adverse events (AEs) per patient years of exposure (PYE) (number of AEs divided by PYE multiplied by 100) after 26 weeks are presented.","populationDescription":"SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"(Number of AEs/PYE)*100","timeFrame":"Weeks 0-26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"267"},{"groupId":"OG001","value":"117"},{"groupId":"OG002","value":"143"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"410.82"},{"groupId":"OG001","value":"306.19"},{"groupId":"OG002","value":"541.00"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment Emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes.","description":"Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \\< 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as nocturnal if the time of the onset was between 00:01 and 05.59 both inclusive. The number of episodes are represented as rates. The observed rates of episodes per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented.","populationDescription":"SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"(Number of episodes/PYE)*100","timeFrame":"Weeks 0-26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4.45"},{"groupId":"OG001","value":"4.54"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes.","description":"Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \\<3.1 mmol/L with symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. The number of episodes are represented as rates. The observed rates of episodes per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented.","populationDescription":"SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"(Number of episodes/PYE)*100","timeFrame":"Weeks 0-26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"1"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"15.03"},{"groupId":"OG001","value":"9.07"},{"groupId":"OG002","value":"1.20"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes","description":"Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \\<3.1 mmol/L with symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as nocturnal if the time of the onset was between 00:01 and 05.59 both inclusive. The number of episodes are represented as rates. The observed rates of episodes per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented.","populationDescription":"SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"(Number of episodes/PYE)*100","timeFrame":"Weeks 0-26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.78"},{"groupId":"OG001","value":"3.40"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition","description":"A hypoglycaemic episode was 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 7 days after the last day on trial product. The number of episodes are represented as rates. The observed rates of episodes (according to the ADA definition) per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented.","populationDescription":"SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"(Number of episodes/PYE)*100","timeFrame":"Weeks 0-26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"236"},{"groupId":"OG001","value":"123"},{"groupId":"OG002","value":"19"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"668.55"},{"groupId":"OG001","value":"746.20"},{"groupId":"OG002","value":"37.19"}]}]}]},{"type":"SECONDARY","title":"Change in Physical Examination","description":"Physical examination parameters are categorised as cardiovascular system; central and peripheral nervous system; gastrointestinal system including mouth; general appearance; head, ears, eyes, nose, throat, neck; lymph node palpation; musculoskeletal system; respiratory system; skin and thyroid gland. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at screening (week -2) and week 26 per each category is presented.","populationDescription":"SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analyzed=participants with available data","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week -2, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"358"},{"groupId":"OG001","value":"175"},{"groupId":"OG002","value":"180"}]}],"classes":[{"title":"Week -2: Cardiovascular system","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"358"},{"groupId":"OG001","value":"175"},{"groupId":"OG002","value":"180"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"353"},{"groupId":"OG001","value":"173"},{"groupId":"OG002","value":"180"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"}]},{"title":"Abnormal CS","measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Week 26: Cardiovascular system","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"336"},{"groupId":"OG001","value":"166"},{"groupId":"OG002","value":"151"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]},{"title":"Abnormal CS","measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Week -2: Central and peripheral nervous system","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"358"},{"groupId":"OG001","value":"175"},{"groupId":"OG002","value":"180"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"355"},{"groupId":"OG001","value":"172"},{"groupId":"OG002","value":"179"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]},{"title":"Abnormal CS","measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"1"}]}]},{"title":"Week 26: Central and peripheral nervous system","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"338"},{"groupId":"OG001","value":"164"},{"groupId":"OG002","value":"150"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]},{"title":"Abnormal CS","measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"1"}]}]},{"title":"Week -2: Gastrointestinal system including mouth","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"358"},{"groupId":"OG001","value":"175"},{"groupId":"OG002","value":"180"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"355"},{"groupId":"OG001","value":"174"},{"groupId":"OG002","value":"179"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"}]},{"title":"Abnormal CS","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Week 26: Gastrointestinal system including mouth","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"339"},{"groupId":"OG001","value":"166"},{"groupId":"OG002","value":"150"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"}]},{"title":"Abnormal CS","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Week -2: General appearance","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"358"},{"groupId":"OG001","value":"175"},{"groupId":"OG002","value":"180"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"351"},{"groupId":"OG001","value":"169"},{"groupId":"OG002","value":"177"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"}]},{"title":"Abnormal CS","measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"2"}]}]},{"title":"Week 26: General appearance","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"336"},{"groupId":"OG001","value":"161"},{"groupId":"OG002","value":"150"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"}]},{"title":"Abnormal CS","measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"1"}]}]},{"title":"Week -2: Head, ears, eyes, nose, throat, neck","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"358"},{"groupId":"OG001","value":"175"},{"groupId":"OG002","value":"180"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"348"},{"groupId":"OG001","value":"170"},{"groupId":"OG002","value":"175"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"3"}]},{"title":"Abnormal CS","measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"}]}]},{"title":"Week 26: Head, ears, eyes, nose, throat, neck","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"332"},{"groupId":"OG001","value":"164"},{"groupId":"OG002","value":"150"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"1"}]},{"title":"Abnormal CS","measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Week -2: Lymph node palpation","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"358"},{"groupId":"OG001","value":"175"},{"groupId":"OG002","value":"180"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"357"},{"groupId":"OG001","value":"174"},{"groupId":"OG002","value":"180"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]},{"title":"Abnormal CS","measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]},{"title":"Week 26: Lymph node palpation","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"340"},{"groupId":"OG001","value":"166"},{"groupId":"OG002","value":"151"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]},{"title":"Abnormal CS","measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]},{"title":"Week -2: Musculoskeletal system","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"358"},{"groupId":"OG001","value":"175"},{"groupId":"OG002","value":"180"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"353"},{"groupId":"OG001","value":"172"},{"groupId":"OG002","value":"177"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"}]},{"title":"Abnormal CS","measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"3"}]}]},{"title":"Week 26: Musculoskeletal system","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"332"},{"groupId":"OG001","value":"165"},{"groupId":"OG002","value":"149"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]},{"title":"Abnormal CS","measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"}]}]},{"title":"Week-2: Respiratory system","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"358"},{"groupId":"OG001","value":"175"},{"groupId":"OG002","value":"180"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"358"},{"groupId":"OG001","value":"175"},{"groupId":"OG002","value":"180"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]},{"title":"Abnormal CS","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Week 26: Respiratory system","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]},{"title":"Abnormal CS","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"week -2: Skin","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"358"},{"groupId":"OG001","value":"175"},{"groupId":"OG002","value":"180"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"312"},{"groupId":"OG001","value":"152"},{"groupId":"OG002","value":"156"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"20"}]},{"title":"Abnormal CS","measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"4"}]}]},{"title":"Week 26: Skin","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"297"},{"groupId":"OG001","value":"146"},{"groupId":"OG002","value":"134"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"19"},{"groupId":"OG002","value":"15"}]},{"title":"Abnormal CS","measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"2"}]}]},{"title":"Week -2: Thyroid gland","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"358"},{"groupId":"OG001","value":"175"},{"groupId":"OG002","value":"180"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"348"},{"groupId":"OG001","value":"171"},{"groupId":"OG002","value":"179"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"}]},{"title":"Abnormal CS","measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"}]}]},{"title":"Week 26: Thyroid gland","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"334"},{"groupId":"OG001","value":"163"},{"groupId":"OG002","value":"151"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"}]},{"title":"Abnormal CS","measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"}]}]}]},{"type":"SECONDARY","title":"Eye Examination","description":"Dilated fundoscopy or fundus photography was performed by the investigator at screening (week -2) and week 26. The results of the examination were interpreted for each eye (left and right) and are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at screening (week -2) and week 26 is presented.","populationDescription":"SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week -2, Week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"358"},{"groupId":"OG001","value":"175"},{"groupId":"OG002","value":"180"}]}],"classes":[{"title":"Week -2: Left eye","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"358"},{"groupId":"OG001","value":"175"},{"groupId":"OG002","value":"180"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"222"},{"groupId":"OG001","value":"109"},{"groupId":"OG002","value":"110"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"20"}]},{"title":"Abnormal, CS","measurements":[{"groupId":"OG000","value":"91"},{"groupId":"OG001","value":"52"},{"groupId":"OG002","value":"50"}]}]},{"title":"Week 26: Left eye","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"217"},{"groupId":"OG001","value":"99"},{"groupId":"OG002","value":"100"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"13"}]},{"title":"Abnormal, CS","measurements":[{"groupId":"OG000","value":"85"},{"groupId":"OG001","value":"48"},{"groupId":"OG002","value":"38"}]}]},{"title":"Week -2: Right eye","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"358"},{"groupId":"OG001","value":"175"},{"groupId":"OG002","value":"180"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"230"},{"groupId":"OG001","value":"112"},{"groupId":"OG002","value":"111"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"22"}]},{"title":"Abnormal, CS","measurements":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"47"},{"groupId":"OG002","value":"47"}]}]},{"title":"Week 26: Right eye","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"217"},{"groupId":"OG001","value":"103"},{"groupId":"OG002","value":"96"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"23"},{"groupId":"OG002","value":"15"}]},{"title":"Abnormal, CS","measurements":[{"groupId":"OG000","value":"84"},{"groupId":"OG001","value":"41"},{"groupId":"OG002","value":"40"}]}]}]},{"type":"SECONDARY","title":"Change in Electrocardiogram (ECG)","description":"Electrocardiogram was assessed by the investigator as normal, abnormal NCS and abnormal CS. Number of participants at screening (week -2) and at week 26 is presented.","populationDescription":"SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week -2, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"358"},{"groupId":"OG001","value":"175"},{"groupId":"OG002","value":"180"}]}],"classes":[{"title":"Week -2","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"358"},{"groupId":"OG001","value":"175"},{"groupId":"OG002","value":"180"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"223"},{"groupId":"OG001","value":"109"},{"groupId":"OG002","value":"108"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"94"},{"groupId":"OG001","value":"46"},{"groupId":"OG002","value":"52"}]},{"title":"Abnormal CS","measurements":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"20"}]}]},{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"categories":[{"title":"Normal","measurements":[{"groupId":"OG000","value":"227"},{"groupId":"OG001","value":"108"},{"groupId":"OG002","value":"87"}]},{"title":"Abnormal, NCS","measurements":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"47"},{"groupId":"OG002","value":"40"}]},{"title":"Abnormal CS","measurements":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"24"}]}]}]},{"type":"SECONDARY","title":"Change in Pulse","description":"Change in pulse from baseline (week 0) after 26 weeks of treatment is presented","populationDescription":"SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Beats per minuts (beats/min)","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4.6","spread":"8.6"},{"groupId":"OG001","value":"-0.1","spread":"8.6"},{"groupId":"OG002","value":"4.9","spread":"9.7"}]}]}]},{"type":"SECONDARY","title":"Change in Blood Pressure (Systolic and Diastolic Blood Pressure)","description":"Change in blood pressure (systolic and diastolic blood pressure) from baseline (week 0) after 26 weeks of treatment is presented","populationDescription":"SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimeters of mercury (mmHg)","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"classes":[{"title":"Systolic blood pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-3.5","spread":"12.7"},{"groupId":"OG001","value":"-1.2","spread":"11.7"},{"groupId":"OG002","value":"-3.3","spread":"13.8"}]}]},{"title":"Distolic blood pressure","categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"8.3"},{"groupId":"OG001","value":"-0.7","spread":"8.1"},{"groupId":"OG002","value":"0.0","spread":"8.4"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum","description":"Change in alkaline phosphatase, ALT, AST, creatine kinase, amylase, lipase, creatine kinase serum from baseline (week 0) after 26 weeks of treatment is presented.","populationDescription":"SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units per liter (U/L)","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"classes":[{"title":"Alkaline phosphatase","categories":[{"measurements":[{"groupId":"OG000","value":"-2.0","spread":"14.85"},{"groupId":"OG001","value":"-2.29","spread":"11.49"},{"groupId":"OG002","value":"-0.48","spread":"14.11"}]}]},{"title":"ALT","categories":[{"measurements":[{"groupId":"OG000","value":"-4.63","spread":"13.06"},{"groupId":"OG001","value":"-6.17","spread":"13.54"},{"groupId":"OG002","value":"-2.81","spread":"16.97"}]}]},{"title":"AST","categories":[{"measurements":[{"groupId":"OG000","value":"-1.31","spread":"7.94"},{"groupId":"OG001","value":"-2.65","spread":"8.40"},{"groupId":"OG002","value":"-0.99","spread":"9.64"}]}]},{"title":"Creatine kinase","categories":[{"measurements":[{"groupId":"OG000","value":"10.67","spread":"100.87"},{"groupId":"OG001","value":"15.37","spread":"52.99"},{"groupId":"OG002","value":"0.52","spread":"56.20"}]}]},{"title":"Amylase","categories":[{"measurements":[{"groupId":"OG000","value":"9.84","spread":"36.73"},{"groupId":"OG001","value":"5.09","spread":"14.68"},{"groupId":"OG002","value":"5.68","spread":"13.70"}]}]},{"title":"Lipase","categories":[{"measurements":[{"groupId":"OG000","value":"16.13","spread":"101.19"},{"groupId":"OG001","value":"-1.87","spread":"15.64"},{"groupId":"OG002","value":"14.11","spread":"19.76"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry Parameters (Albumin Serum, Total Protein)","description":"Change in total protein, albumin serum from baseline (week 0) after 26 weeks of treatment is presented.","populationDescription":"SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"grams per decileter (g/dL)","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"classes":[{"title":"Albumin serum","categories":[{"measurements":[{"groupId":"OG000","value":"-0.05","spread":"0.28"},{"groupId":"OG001","value":"-0.09","spread":"0.26"},{"groupId":"OG002","value":"0.04","spread":"0.26"}]}]},{"title":"Total protein","categories":[{"measurements":[{"groupId":"OG000","value":"-0.08","spread":"0.42"},{"groupId":"OG001","value":"-0.08","spread":"0.39"},{"groupId":"OG002","value":"-0.01","spread":"0.39"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum","description":"Change in calcium serum (total), calcium corrected serum, potassium serum, sodium serum, urea serum from baseline (week 0) after 26 weeks of treatment is presented.","populationDescription":"SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"classes":[{"title":"Calcium serum (total)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.01","spread":"0.10"},{"groupId":"OG001","value":"-0.02","spread":"0.10"},{"groupId":"OG002","value":"-0.00","spread":"0.09"}]}]},{"title":"Calcium corrected serum","categories":[{"measurements":[{"groupId":"OG000","value":"-0.00","spread":"0.08"},{"groupId":"OG001","value":"-0.00","spread":"0.08"},{"groupId":"OG002","value":"-0.01","spread":"0.07"}]}]},{"title":"Sodium serum","categories":[{"measurements":[{"groupId":"OG000","value":"1.21","spread":"2.09"},{"groupId":"OG001","value":"0.98","spread":"2.37"},{"groupId":"OG002","value":"0.32","spread":"2.12"}]}]},{"title":"Urea serum","categories":[{"measurements":[{"groupId":"OG000","value":"0.05","spread":"0.57"},{"groupId":"OG001","value":"0.03","spread":"0.53"},{"groupId":"OG002","value":"0.16","spread":"0.67"}]}]},{"title":"Potassium serum","categories":[{"measurements":[{"groupId":"OG000","value":"-0.04","spread":"0.34"},{"groupId":"OG001","value":"-0.09","spread":"0.39"},{"groupId":"OG002","value":"-0.04","spread":"0.34"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry Parameters: Total Bilirubin Serum, Creatinine Serum","description":"Change in total bilirubin serum, creatinine serum from baseline (week 0) after 26 weeks of treatment is presented.","populationDescription":"SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"micromoles per liter (umol/L)","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"classes":[{"title":"Total bilirubin","categories":[{"measurements":[{"groupId":"OG000","value":"-0.78","spread":"3.35"},{"groupId":"OG001","value":"-0.55","spread":"4.52"},{"groupId":"OG002","value":"-1.16","spread":"3.92"}]}]},{"title":"creatinine serum","categories":[{"measurements":[{"groupId":"OG000","value":"1.02","spread":"8.41"},{"groupId":"OG001","value":"1.36","spread":"7.92"},{"groupId":"OG002","value":"-0.60","spread":"7.89"}]}]}]},{"type":"SECONDARY","title":"Change in Haematological Parameter: Erythrocytes Blood","description":"Change in erythrocyte blood from baseline (week 0) after 26 weeks of treatment is presented.","populationDescription":"SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"10^12 cells per liter (10^12/L)","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"150"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.05","spread":"0.27"},{"groupId":"OG001","value":"-0.00","spread":"0.27"},{"groupId":"OG002","value":"-0.05","spread":"0.25"}]}]}]},{"type":"SECONDARY","title":"Change in Haematological Parameter: Haematocrits","description":"Change in haematocrits from baseline (week 0) after 26 weeks of treatment is presented.","populationDescription":"SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage points (%) of red blood cells","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"150"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.56","spread":"2.65"},{"groupId":"OG001","value":"-0.49","spread":"2.69"},{"groupId":"OG002","value":"-0.42","spread":"2.57"}]}]}]},{"type":"SECONDARY","title":"Change in Haemotological Parameter- Eosinophils","description":"Change in eosinophils from baseline after 26 weeks of treatment is presented.","populationDescription":"SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"% of eosinophils","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"150"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.06","spread":"1.90"},{"groupId":"OG001","value":"0.19","spread":"1.73"},{"groupId":"OG002","value":"0.11","spread":"1.94"}]}]}]},{"type":"SECONDARY","title":"Change in Haematological Parameter - Neutrophils","description":"Change in neutrophils from baseline (week 0) after 26 weeks of treatment is presented.","populationDescription":"SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"% of neutrophils","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"150"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.57","spread":"6.46"},{"groupId":"OG001","value":"0.18","spread":"7.70"},{"groupId":"OG002","value":"-0.53","spread":"7.05"}]}]}]},{"type":"SECONDARY","title":"Change in Haematological Parameter: Basophils","description":"Change in basophils from baseline (week 0) after 26 weeks of treatment is presented.","populationDescription":"SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"% of basophils","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"150"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.02","spread":"0.29"},{"groupId":"OG001","value":"-0.01","spread":"0.28"},{"groupId":"OG002","value":"-0.03","spread":"0.26"}]}]}]},{"type":"SECONDARY","title":"Change in Haemotological Parameter- Monocytes","description":"Change in monocytes from baseline (week 0) after 26 weeks of treatment is presented","populationDescription":"SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"% of monocytes","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"150"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.03","spread":"1.92"},{"groupId":"OG001","value":"0.01","spread":"1.85"},{"groupId":"OG002","value":"0.05","spread":"2.13"}]}]}]},{"type":"SECONDARY","title":"Change in Haematological Parameter - Lymphocytes","description":"Change in lymphocytes from baseline (week 0) after 26 weeks of treatment is presented","populationDescription":"SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"% of lymphocytes","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"150"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.46","spread":"6.04"},{"groupId":"OG001","value":"-0.38","spread":"7.12"},{"groupId":"OG002","value":"0.40","spread":"6.11"}]}]}]},{"type":"SECONDARY","title":"Change in Haematology: Haemoglobin Blood","description":"Change in haemoglobin from baseline (week 0) after 26 weeks of treatment is presented.","populationDescription":"SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"150"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.10","spread":"0.53"},{"groupId":"OG001","value":"-0.06","spread":"0.48"},{"groupId":"OG002","value":"-0.05","spread":"0.47"}]}]}]},{"type":"SECONDARY","title":"Change in Haematologcal Parameter: Leukocytes","description":"Change in leukocytes from baseline (week 0) after 26 weeks of treatment","populationDescription":"SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"10^9 cells per liter (10^9/L)","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"150"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.25","spread":"1.18"},{"groupId":"OG001","value":"0.23","spread":"1.41"},{"groupId":"OG002","value":"-0.01","spread":"1.14"}]}]}]},{"type":"SECONDARY","title":"Change in Haematological Parameter: Thrombocytes","description":"Change in thrombocytes from baseline (week 0) after 26 weeks of treatment","populationDescription":"SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"10^9 cells per liter (10^9/L)","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"340"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"149"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8.19","spread":"28.02"},{"groupId":"OG001","value":"8.32","spread":"34.48"},{"groupId":"OG002","value":"4.32","spread":"33.39"}]}]}]},{"type":"SECONDARY","title":"Change in Calcitonin","description":"Calcitonin levels were measured and were categorised as low, normal or high in relation to reference range (8.31- 14.3 picogram/milliliter \\[pg/mL\\]). Number of participants in each category at baseline (week 0) and week 26 are presented.","populationDescription":"SAS included all participants who received at least one dose of Insulin degludec/liraglutide, insulin degludec or liraglutide. Number analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"358"},{"groupId":"OG001","value":"175"},{"groupId":"OG002","value":"180"}]}],"classes":[{"title":"Week 0","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"358"},{"groupId":"OG001","value":"175"},{"groupId":"OG002","value":"180"}]}],"categories":[{"title":"Low","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]},{"title":"Normal","measurements":[{"groupId":"OG000","value":"351"},{"groupId":"OG001","value":"172"},{"groupId":"OG002","value":"178"}]},{"title":"High","measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"}]}]},{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"340"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"150"}]}],"categories":[{"title":"Low","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]},{"title":"Normal","measurements":[{"groupId":"OG000","value":"334"},{"groupId":"OG001","value":"165"},{"groupId":"OG002","value":"147"}]},{"title":"High","measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"3"}]}]}]},{"type":"SECONDARY","title":"Urinalysis (Protein, Glucose, Erythrocytes and Ketones)","description":"The urinalysis assessment was the measurements of protein, glucose, erythrocytes and ketones in urine at baseline (week 0) and week 26 and categorised as negative, trace and positive. Number of participants in each category at week 0 and week 26 is presented.","populationDescription":"SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."},{"id":"OG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"357"},{"groupId":"OG001","value":"175"},{"groupId":"OG002","value":"180"}]}],"classes":[{"title":"Week 0: Erythrocytes","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"357"},{"groupId":"OG001","value":"175"},{"groupId":"OG002","value":"180"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"299"},{"groupId":"OG001","value":"153"},{"groupId":"OG002","value":"156"}]},{"title":"Trace","measurements":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"16"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"8"}]}]},{"title":"Week 26: Erythrocytes","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"339"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"297"},{"groupId":"OG001","value":"146"},{"groupId":"OG002","value":"136"}]},{"title":"Trace","measurements":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"11"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"4"}]}]},{"title":"Week 0: Glucose","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"357"},{"groupId":"OG001","value":"175"},{"groupId":"OG002","value":"180"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"253"},{"groupId":"OG001","value":"119"},{"groupId":"OG002","value":"123"}]},{"title":"Trace","measurements":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"19"},{"groupId":"OG002","value":"18"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"69"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"39"}]}]},{"title":"Week 26: Glucose","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"339"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"322"},{"groupId":"OG001","value":"157"},{"groupId":"OG002","value":"131"}]},{"title":"Trace","measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"5"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"15"}]}]},{"title":"Week 0: Ketones","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"357"},{"groupId":"OG001","value":"175"},{"groupId":"OG002","value":"180"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"325"},{"groupId":"OG001","value":"152"},{"groupId":"OG002","value":"167"}]},{"title":"Trace","measurements":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"11"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"}]}]},{"title":"Week 26: Ketones","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"339"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"334"},{"groupId":"OG001","value":"163"},{"groupId":"OG002","value":"141"}]},{"title":"Trace","measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"10"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]},{"title":"Week 0: Protein","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"357"},{"groupId":"OG001","value":"175"},{"groupId":"OG002","value":"180"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"216"},{"groupId":"OG001","value":"104"},{"groupId":"OG002","value":"116"}]},{"title":"Trace","measurements":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"37"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"55"},{"groupId":"OG001","value":"31"},{"groupId":"OG002","value":"27"}]}]},{"title":"Week 26: Protein","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"339"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"151"}]}],"categories":[{"title":"Negative","measurements":[{"groupId":"OG000","value":"254"},{"groupId":"OG001","value":"120"},{"groupId":"OG002","value":"105"}]},{"title":"Trace","measurements":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"26"},{"groupId":"OG002","value":"28"}]},{"title":"Positive","measurements":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"21"},{"groupId":"OG002","value":"18"}]}]}]},{"type":"SECONDARY","title":"Occurence of Anti-insulin Degludec Specific Antibodies","description":"This outcome measure is only applicable for the insulin degludec/liraglutide arm and insulin degludec arm. Serum samples were analysed for the presence of anti-insulin degludec specific antibodies. Results at week 27 are presented as percentage of bound radioactive-labelled insulin (B) /total radioactive-labelled insulin added to the samples (T).","populationDescription":"SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"%B/T","timeFrame":"Week 27","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"332"},{"groupId":"OG001","value":"166"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.22","spread":"1.02"},{"groupId":"OG001","value":"0.12","spread":"0.79"}]}]}]},{"type":"SECONDARY","title":"Occurence of Antibodies Cross-reacting to Human Insulin","description":"This outcome measure is only applicable for the insulin degludec/liraglutide arm and insulin degludec arm. Serum samples were analysed for the presence of cross-reacting antibodies to human insulin. Results at week 27 are presented as percentage of bound radioactive-labelled insulin (B) /total radioactive-labelled insulin added to the samples (T).","populationDescription":"SAS included all participants who received at least one dose of insulin degludec/liraglutide or insulin degludec. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"%B/T","timeFrame":"Week 27","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"332"},{"groupId":"OG001","value":"166"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.61","spread":"15.00"},{"groupId":"OG001","value":"2.99","spread":"10.89"}]}]}]},{"type":"SECONDARY","title":"Occurence of Total Insulin Antibodies","description":"This outcome measure is only applicable for the Insulin degludec/liraglutide arm and Insulin degludec arm. Serum samples were analysed for the presence of antobodies to human insulin. Results at week 27 are presented as percentage of bound radioactive-labelled insulin (B) /total radioactive-labelled insulin added to the samples (T).","populationDescription":"SAS included all participants who received at least one dose of insulin degludec/liraglutide or insulin degludec. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"%B/T","timeFrame":"Week 27","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"332"},{"groupId":"OG001","value":"166"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.83","spread":"15.78"},{"groupId":"OG001","value":"3.11","spread":"11.42"}]}]}]},{"type":"SECONDARY","title":"Occurence of Anti-liraglutide Antibodies","description":"This outcome measure is applicable for the Insulin degludec/liraglutide arm and the liraglutide arm. Serum samples were analysed for the presence of anti-liraglutide antibodies. Number of participants who were assessed for anti-liraglutide antibodies at week 27 are presented.","populationDescription":"SAS included all participants who received at least one dose of insulin degludec/liraglutide or insulin degludec. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 27","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"332"},{"groupId":"OG001","value":"160"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"40"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"287"},{"groupId":"OG001","value":"120"}]}]}]},{"type":"SECONDARY","title":"Occurence of Antibodies Cross-reacting to Native Glucagon-like Peptide (GLP-1)","description":"This outcome measure is applicable to the Insulin degludec/liraglutide arm and the liraglutide arm. Serum samples were analysed for the presence of cross-reacting antibodies to native GLP-1. Number of participants who measured with anti-liraglutide antibodies cross reacting native GLP-1 at week 27 are presented.","populationDescription":"SAS included all participants who received at least one dose of insulin degludec/liraglutide or insulin degludec. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 27","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"332"},{"groupId":"OG001","value":"160"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"3"}]}]}]},{"type":"SECONDARY","title":"Occurence of Neutralising Liraglutide Antibodies","description":"This outcome measure is only applicable for the Insulin degludec/liraglutide arm and liraglutide arm. Neutralising antibodies were assessed when the corresponding anti-Liraglutide antibody were positive at week 27. Number of participants who measured with neutralising liraglutide antibodies at week 27 are presented.","populationDescription":"SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 27","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"332"},{"groupId":"OG001","value":"160"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"8"}]}]}]},{"type":"SECONDARY","title":"Occurence of Neutralising Antibodies Cross-reacting to Native GLP-1","description":"This outcome measure is only applicable for the Insulin degludec/liraglutide arm and liraglutide arm. Cross reacting antibodies were assessed when anti-liraglutide antibody was positive. Number of participants who measured with neutralising liraglutide antibodies cross-reacting to native GLP-1 at week 27 are presented.","populationDescription":"SAS included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 27","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"332"},{"groupId":"OG001","value":"160"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},{"type":"SECONDARY","title":"Serum Concentrations of Insulin Degludec","description":"This outcome measure is applicable for Insulin degludec and Insulin degludec/liraglutide arms. Serum samples from the Insulin degludec/liraglutide and Insulin degludec arms were assayed using population PK analysis. The maximum serum concentrations (Cmax) are summarised for the two arms.","populationDescription":"FAS included all randomised participants. Overall the number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"pmol/L","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"339"},{"groupId":"OG001","value":"168"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3583","spread":"55.9"},{"groupId":"OG001","value":"4133","spread":"52.8"}]}]}]},{"type":"SECONDARY","title":"Plasma Concentration of Liraglutide","description":"This outcome measure is for Insulin degludec/liraglutide and liraglutide arms. Serum samples from the Insulin degludec/liraglutide and liraglutide arms were assayed using population PK analysis. The Cmax are summarised for the two arms.","populationDescription":"FAS included all randomised participants. Overall number of participants analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"pmol/L","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide."},{"id":"OG001","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\""}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"339"},{"groupId":"OG001","value":"165"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9963","spread":"50.4"},{"groupId":"OG001","value":"21602","spread":"37"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Weeks 0-30","description":"A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Results are based on SAS which included all participants who received at least one dose of insulin degludec/liraglutide, insulin degludec or liraglutide","eventGroups":[{"id":"EG000","title":"Insulin Degludec/Liraglutide","description":"Participants were to receive Insulin degludec/liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.","deathsNumAffected":0,"deathsNumAtRisk":358,"seriousNumAffected":14,"seriousNumAtRisk":358,"otherNumAffected":161,"otherNumAtRisk":358},{"id":"EG001","title":"Insulin Degludec","description":"Participants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.","deathsNumAffected":0,"deathsNumAtRisk":175,"seriousNumAffected":7,"seriousNumAtRisk":175,"otherNumAffected":55,"otherNumAtRisk":175},{"id":"EG002","title":"Liraglutide","description":"Participants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment.\"","deathsNumAffected":0,"deathsNumAtRisk":180,"seriousNumAffected":14,"seriousNumAtRisk":180,"otherNumAffected":98,"otherNumAtRisk":180}],"seriousEvents":[{"term":"Abdominal pain upper","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":358},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":175},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":180}]},{"term":"Angina unstable","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":358},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":175},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":180}]},{"term":"Ankle fracture","organSystem":"Injury, poisoning and 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