{"protocolSection":{"identificationModule":{"nctId":"NCT02501161","orgStudyIdInfo":{"id":"NN9068-4228"},"secondaryIdInfos":[{"id":"2014-005639-15","type":"EUDRACT_NUMBER"},{"id":"U1111-1165-3914","type":"OTHER","domain":"WHO"},{"id":"2014","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2014"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"A 104 Week Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus","officialTitle":"A Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus","acronym":"DUAL™ VIII"},"statusModule":{"statusVerifiedDate":"2019-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2016-01-31","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2018-10-03","type":"ACTUAL"},"completionDateStruct":{"date":"2018-10-03","type":"ACTUAL"},"studyFirstSubmitDate":"2015-07-15","studyFirstSubmitQcDate":"2015-07-15","studyFirstPostDateStruct":{"date":"2015-07-17","type":"ESTIMATED"},"resultsFirstSubmitDate":"2019-10-03","resultsFirstSubmitQcDate":"2019-11-08","resultsFirstPostDateStruct":{"date":"2019-11-27","type":"ACTUAL"},"lastUpdateSubmitDate":"2019-11-08","lastUpdatePostDateStruct":{"date":"2019-11-27","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This trial is conducted in Africa, Asia, Europe, North America and South America. The purpose is to compare long-term glycaemic control of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) in insulin naïve subjects with type 2 diabetes mellitus inadequately controlled with oral anti diabetics."},"conditionsModule":{"conditions":["Diabetes","Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":1012,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Insulin degludec/liraglutide QD + OAD(s)","type":"EXPERIMENTAL","interventionNames":["Drug: insulin degludec/liraglutide"]},{"label":"insulin glargine QD + OAD(s)","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: insulin glargine"]}],"interventions":[{"type":"DRUG","name":"insulin degludec/liraglutide","description":"Injected subcutaneously (under the skin) once daily for 104 weeks. Dose individually adjusted.","armGroupLabels":["Insulin degludec/liraglutide QD + OAD(s)"]},{"type":"DRUG","name":"insulin glargine","description":"Injected subcutaneously (under the skin) once daily for 104 weeks. Dose individually adjusted.","armGroupLabels":["insulin glargine QD + OAD(s)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification","description":"Inadequate glycaemic control and need for treatment intensification was defined as a glycosylated haemoglobin (HbA1c) of 7.0% or greater at 2 consecutive visits from week 26, including week 26 if HbA1c was greater than or equal to 7% at week 12. Time from randomisation to inadequate glycaemic control and need for treatment intensification was analysed using a stratified log-rank test where treatment, baseline HbA1c group and previous OAD treatment were included as strata in the model. The variable \"baseline HbA1c group\" was a dichotomised baseline HbA1c variable with 2 categories: HbA1c \\< 8.5% or HbA1c ≥ 8.5% and the variable \"previous OAD treatment\" was a categorical variable with 2 categories: SU ± OAD(s) (SU users) or OAD(s) (Non-SU users). 25%, median (50%) and 75% percentiles for the cumulative distribution function were obtained from the Kaplan-Meier survival function.","timeFrame":"Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2"}],"secondaryOutcomes":[{"measure":"Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits","description":"Time to HbA1c \\> 6.5% at 2 consecutive visits is defined as time from randomization to HbA1c \\> 6.5% at 2 consecutive planned scheduled visits from week 26 (including week 26 if HbA1c was \\> 6.5% at week 12). Time from randomisation to HbA1c \\>6.5% at 2 consecutive visits was analysed using a stratified log-rank test where treatment, baseline HbA1c group and previous OAD treatment were included as strata in the model. The variable \"baseline HbA1c group\" was a dichotomised baseline HbA1c variable with 2 categories: HbA1c \\< 8.5% or HbA1c ≥ 8.5% and the variable \"previous OAD treatment\" was a categorical variable with 2 categories: SU ± OAD(s) (SU users) or OAD(s) (Non-SU users). 25%, median (50%) and 75% percentiles for the cumulative distribution function were obtained from the Kaplan-Meier survival function.","timeFrame":"Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2"},{"measure":"Change in HbA1c","description":"Change in HbA1c from baseline (week 0) to week 26 is presented.","timeFrame":"Week 0, week 26"},{"measure":"Change in Body Weight","description":"Change in body weight from baseline (week 0) to week 26 and week 104 is presented.","timeFrame":"Week 0, week 26, week 104"},{"measure":"Insulin Dose","description":"Insulin dose after 26 and 104 weeks of treatment is presented.","timeFrame":"Week 26, week 104"},{"measure":"Participants Who Achieved (Yes/no): HbA1c <7.0%","description":"Percentage of participants who achieved (yes/no) HbA1c \\<7.0% at week 26 and week 104 is presented.","timeFrame":"Week 26, week 104"},{"measure":"Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain","description":"Percentage of participants who achieved (yes/no) HbA1c \\<7.0% without weight gain at week 26 and week 104 is presented.","timeFrame":"Week 26, week 104"},{"measure":"Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes","description":"Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) 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. Percentage of participants who achieved (yes/no) HbA1c \\<7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes at week 26 and week 104 is presented.","timeFrame":"Week 26, week 104"},{"measure":"Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain","description":"Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the ADA classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) 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. Percentage of participants who achieved (yes/no) HbA1c \\<7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and without weight gain at week 26 and week 104 is presented.","timeFrame":"Week 26, week 104"},{"measure":"Participants Who Achieved (Yes/no): HbA1c ≤6.5%","description":"Percentage of participants who achieved (yes/no) HbA1c ≤6.5% at week 26 and week 104 is presented.","timeFrame":"Week 26, week 104"},{"measure":"Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain","description":"Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without weight gain at week 26 and week 104 is presented.","timeFrame":"Week 26, week 104"},{"measure":"Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes","description":"Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) 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. Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes at week 26 and week 104 is presented.","timeFrame":"Week 26, week 104"},{"measure":"Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain","description":"Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) 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. Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and without weight gain at week 26 and week 104 is presented.","timeFrame":"Week 26, week 104"},{"measure":"Change in FPG","description":"Change in fasting plasma glucose (FPG) from baseline (week 0) to week 26 and week 104 is presented.","timeFrame":"Week 0, week 26, week 104"},{"measure":"SMPG-9-point Profile (Individual Points in the Profile)","description":"Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Self-measured plasma glucose (SMPG)-9-point profile (individual points in the profile) at week 26 and week 104 is presented.","timeFrame":"Week 26, week 104"},{"measure":"Change in SMPG-mean 9-point Profile","description":"Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Change in SMPG-mean 9-point profile from baseline (week 0) to week 26 and week 104 is presented.","timeFrame":"Week 0, week 26, week 104"},{"measure":"Change in SMPG-mean Postprandial Increment Over All Meals","description":"Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Change in SMPG-mean postprandial increment over all meals from baseline (week 0) to week 26 and week 104 is presented.","timeFrame":"Week 0, week 26, week 104"},{"measure":"Change in Blood Pressure (Systolic and Diastolic)","description":"Change in blood pressure (systolic and diastolic) from baseline (week 0) to week 26 and week 104 is presented.","timeFrame":"Week 0, week 26, week 104"},{"measure":"Change in Fasting C-peptide","description":"Change in fasting C-peptide (measured in nanomoles per liter \\[nmol/L\\]) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.","timeFrame":"Week 0, week 26, week 104"},{"measure":"Change in Fasting Human Insulin","description":"Change in fasting human insulin (measured in picomoles per liter \\[pmol/L\\]) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.","timeFrame":"Week 0, week 26, week 104"},{"measure":"Change in Fasting Total Cholesterol","description":"Change in fasting total cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.","timeFrame":"Week 0, week 26, week 104"},{"measure":"Change in Fasting LDL-cholesterol","description":"Change in fasting low density lipoprotein (LDL)-cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.","timeFrame":"Week 0, week 26, week 104"},{"measure":"Change in Fasting HDL-cholesterol","description":"Change in fasting high density lipoprotein (HDL)- cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.","timeFrame":"Week 0, week 26, week 104"},{"measure":"Change in Fasting VLDL-cholesterol","description":"Change in fasting very low density lipoprotein (VLDL)-cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.","timeFrame":"Week 0, week 26, week 104"},{"measure":"Change in Fasting Triglycerides","description":"Change in fasting triglycerides (measured as mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.","timeFrame":"Week 0, week 26, week 104"},{"measure":"Change in Fasting Free Fatty Acids","description":"Change in fasting free fatty acids (measured as mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.","timeFrame":"Week 0, week 26, week 104"},{"measure":"Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment","description":"Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) 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. Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during 26 weeks of treatment is presented.","timeFrame":"Weeks 0-26"},{"measure":"Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment","description":"Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) 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. Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during 104 weeks of treatment is presented.","timeFrame":"Weeks 0-104"},{"measure":"Number of Treatment Emergent Hypoglycaemic Episodes During 26 Weeks of Treatment","description":"Hypoglycaemic episodes (SMPG value ≤3.9 mmol/L (70 mg/dL)) 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 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 treatment-emergent hypoglycaemic episodes according to ADA during 26 weeks of treatment is presented.","timeFrame":"Weeks 0-26"},{"measure":"Number of Treatment Emergent Hypoglycaemic Episodes During 104 Weeks of Treatment","description":"Hypoglycaemic episodes (SMPG value ≤3.9 mmol/L (70 mg/dL)) 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 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 treatment emergent hypoglycaemic episodes according to ADA during 104 weeks of treatment is presented.","timeFrame":"Weeks 0-104"},{"measure":"Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment","description":"Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 both inclusive. 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 treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes during 26 weeks of treatment is presented.","timeFrame":"Weeks 0-26"},{"measure":"Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment","description":"Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 both inclusive. 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 treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes during 104 weeks of treatment is presented.","timeFrame":"Weeks 0-104"},{"measure":"Number of TEAEs During 26 Weeks of Treatment","description":"An adverse event is any untoward medical occurrence in a participant administered a product, and which does not necessarily have a causal relationship with this treatment. A treatment emergent adverse event (TEAE) was defined as an adverse event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product. If the event had onset date before the first day of exposure on trial product and increased in severity during the treatment period and until 7 days after the last drug date, then this event was also considered as a TEAE. Number of TEAEs during 26 weeks of treatment is presented.","timeFrame":"Weeks 0-26"},{"measure":"Number of TEAEs During 104 Weeks of Treatment","description":"An adverse event is any untoward medical occurrence in a participant administered a product, and which does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product. If the event had onset date before the first day of exposure on trial product and increased in severity during the treatment period and until 7 days after the last drug date, then this event was also considered as a TEAE. Number of TEAEs during 104 weeks of treatment is presented.","timeFrame":"Week 0 to week 104"},{"measure":"Eye Examination Category","description":"Fundus photography or a dilated fundoscopy was performed at baseline (within 12 weeks prior to week 0) and week 104. The investigator interpreted each eye's (left and right) results and categorised them as: normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). Number of participants in each category at baseline and week 104 were presented.","timeFrame":"Baseline (within 12 weeks prior to week 0), week 104"},{"measure":"ECG Evaluation","description":"The electrocardiogram (ECG) was assessed at baseline (within 2 weeks prior to week 0) and week 104. The investigator interpreted the results and categorised them as: normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 104 are presented.","timeFrame":"Baseline (within 2 weeks prior to week 0), week 104"},{"measure":"Change in Urine Albumin/Creatinine Ratio","description":"Change in urine albumin/creatinine ratio from baseline (week 0) to week 104 is presented.","timeFrame":"Week 0, week 104"},{"measure":"Change in Pulse Rate","description":"Change in pulse rate from baseline (week 0) to week 26 and week 104 is presented.","timeFrame":"Week 0, week 26, week 104"},{"measure":"Change in Biochemistry Parameter- Creatinine, Total Bilirubin","description":"Change in biochemistry parameter- creatinine, total bilirubin from baseline (week 0) to week 26 and week 104 is presented.","timeFrame":"Week 0, week 26, week 104"},{"measure":"Change in Biochemistry Parameter- Albumin","description":"Change in biochemistry parameter- albumin from baseline (week 0) to week 26 and week 104 is presented.","timeFrame":"Week 0, week 26, week 104"},{"measure":"Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase","description":"Change in biochemistry parameters- alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lipase and amylase from baseline (week 0) to week 26 and week 104 is presented.","timeFrame":"Week 0, week 26, week 104"},{"measure":"Change in Biochemistry Parameter- Sodium, Potassium and Calcium","description":"Change in sodium, potassium and calcium from baseline (week 0) to week 26 and week 104 is presented.","timeFrame":"Week 0, week 26, week 104"},{"measure":"Change in Haematological Parameter- Haemoglobin","description":"Change in haemoglobin from baseline (week 0) to week 26 and week 104 is presented.","timeFrame":"Week 0, week 26, week 104"},{"measure":"Change in Haematological Parameter- Haematocrit","description":"Change in haematocrit from baseline (week 0) to week 26 and week 104 is presented.","timeFrame":"Week 0, week 26, week 104"},{"measure":"Change in Haematological Parameter- Erythrocytes","description":"Change in erythrocytes from baseline (week 0) to week 26 and week 104 is presented.","timeFrame":"Week 0, week 26, week 104"},{"measure":"Change in Haematological Parameter- Thrombocytes and Leukocytes","description":"Change in thrombocytes and leukocytes from baseline (week 0) to week 26 and week 104 is presented.","timeFrame":"Week 0, week 26, week 104"},{"measure":"Change in Haematological Parameter- Eosinophils","description":"Change in eosinophils from baseline (week 0) to week 26 and week 104 is presented.","timeFrame":"Week 0, week 26, week 104"},{"measure":"Change in Haematological Parameter- Neutrophils","description":"Change in neutrophils from baseline (week 0) to week 26 and week 104 is presented.","timeFrame":"Week 0, week 26, week 104"},{"measure":"Change in Haematological Parameter- Basophils","description":"Change in basophils from baseline (week 0) to week 26 and week 104 is presented.","timeFrame":"Week 0, week 26, week 104"},{"measure":"Change in Haematological Parameter- Monocytes","description":"Change in monocytes from baseline (week 0) to week 26 and week 104 is presented.","timeFrame":"Week 0, week 26, week 104"},{"measure":"Change in Haematological Parameter- Lymphocytes","description":"Change in lymphocytes from baseline (week 0) to week 26 and week 104 is presented.","timeFrame":"Week 0, week 26, week 104"},{"measure":"Change in Calcitonin","description":"The number of participants who reported low, normal and high levels of calcitonin in relation to reference ranges at baseline (week 0), week 26 and week 104 are presented.","timeFrame":"Week 0, week 26, week 104"},{"measure":"Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)","description":"SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in the sub-domain scores and component summary (PCS and MCS) scores are presented. A positive change score indicates an improvement since baseline.","timeFrame":"Week 0, week 26, week 104"},{"measure":"Change in TRIM-D","description":"Treatment related impact measures-diabetes (TRIM-D) was developed according to the FDA guidance from 2009 on development of new PRO measures. The questionnaire consists of 5 sub-domains, which are scored according to a 1-5 point scale with a higher score indicating a better health state (less negative impact). Sub-domain scores are calculated by summing across items in the same sub-domain, and the total score is calculated by summing scores from all the sub-domains. The highest possible summed score within a sub-domain ranges from 20 (compliance sub-domain) to 40 (psychological health sub-domain) points and the highest possible total score is 140 points. Change in TRIM-D total score from baseline (week 0) to week 26 and week 104 is presented. A positive change score indicates an improvement since baseline.","timeFrame":"Week 0, week 26, week 104"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female, age greater than or equal to 18 years at the time of signing informed consent\n* Subjects diagnosed with type 2 diabetes mellitus\n* HbA1c 7.0-11.0% (both inclusive) (53-97 mmol/mol) by central laboratory analysis\n* Body mass index greater than or equal to 20 kg/m\\^2\n* Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes\n* Stable daily dose(s) including any of the following antidiabetic drug(s)/regimens within 90 days prior to the day of screening: a) Biguanides (metformin greater than or equal to 1500 mg or maximum tolerated dose documented in the subject medical record), b) Other OAD(s) allowed: sulphonylurea, glinides, pioglitazone, and DPP4-inhibitors (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subjects medical record)\n\nExclusion Criteria:\n\n* Screening calcitonin greater than or equal to 50 ng/L\n* Renal impairment estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min/1.73 m2 as per CKD-EPI value to be defined as listed in the classification CKD-EPI using IDMS for serum creatinine measurement on the day of screening\n* Impaired liver function, defined as ALAT or ASAT greater than or equal to 2.5 times upper limit of normal\n* Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma\n* History of pancreatitis (acute or chronic)\n* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening\n* Anticipated initiation or change in concomitant medications for more than 14 consecutive days or on a frequent basis known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)","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":"Muscle Shoals","state":"Alabama","zip":"35662","country":"United States","geoPoint":{"lat":34.74481,"lon":-87.66753}},{"facility":"Novo Nordisk Investigational Site","city":"Tuscumbia","state":"Alabama","zip":"35674","country":"United States","geoPoint":{"lat":34.7312,"lon":-87.70253}},{"facility":"Novo Nordisk Investigational Site","city":"Glendale","state":"Arizona","zip":"85306-4652","country":"United States","geoPoint":{"lat":33.53865,"lon":-112.18599}},{"facility":"Novo Nordisk Investigational Site","city":"Glendale","state":"Arizona","zip":"85308","country":"United States","geoPoint":{"lat":33.53865,"lon":-112.18599}},{"facility":"Novo Nordisk Investigational Site","city":"Phoenix","state":"Arizona","zip":"85018","country":"United States","geoPoint":{"lat":33.44838,"lon":-112.07404}},{"facility":"Novo Nordisk Investigational Site","city":"Phoenix","state":"Arizona","zip":"85020","country":"United States","geoPoint":{"lat":33.44838,"lon":-112.07404}},{"facility":"Novo Nordisk Investigational Site","city":"Phoenix","state":"Arizona","zip":"85050","country":"United States","geoPoint":{"lat":33.44838,"lon":-112.07404}},{"facility":"Novo Nordisk Investigational Site","city":"Bermuda Dunes","state":"California","zip":"92203","country":"United States","geoPoint":{"lat":33.7428,"lon":-116.28918}},{"facility":"Novo Nordisk Investigational Site","city":"Fresno","state":"California","zip":"93720","country":"United States","geoPoint":{"lat":36.74773,"lon":-119.77237}},{"facility":"Novo Nordisk Investigational 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Durability of insulin degludec plus liraglutide versus insulin glargine U100 as initial injectable therapy in type 2 diabetes (DUAL VIII): a multicentre, open-label, phase 3b, randomised controlled trial. Lancet Diabetes Endocrinol. 2019 Aug;7(8):596-605. doi: 10.1016/S2213-8587(19)30184-6. Epub 2019 Jun 9."},{"pmid":"36710452","type":"DERIVED","citation":"Philis-Tsimikas A, Aroda VR, De Block C, Billings LK, Liebl A, Sivarathinasami R, D'Cruz JM, Lingvay I. Higher Derived Time in Range With IDegLira Versus Insulin Glargine U100 in People With Type 2 Diabetes. J Diabetes Sci Technol. 2024 May;18(3):653-659. doi: 10.1177/19322968221149041. Epub 2023 Jan 29."}],"seeAlsoLinks":[{"label":"Clinical Trials at Novo Nordisk","url":"http://novonordisk-trials.com"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants were randomised in a 1:1 manner to receive either IDegLira or IGlar as an adjunct to oral anti-diabetic drugs (OADs). OADs allowed were: biguanides, sulphonylurea (SU), glinides, pioglitazone, and dipeptidyl peptidase-4 inhibitors (DPP4-inhibitors), though glinides and DPP4-inhibitors were not allowed as monotherapy or in combination.","recruitmentDetails":"The trial was conducted at 130 sites in Argentina (4),Czech Republic (4), Hungary (5), India (11), Israel (8), Italy (7), Mexico (4), Norway (7), Poland (3), Russian Federation (8), Slovakia (5), South Africa (10), Turkey (8), United Kingdom (9) and United States (37).","groups":[{"id":"FG000","title":"Insulin Degludec/Liraglutide","description":"Participants received subcutaneous (s.c.) injection of Insulin degludec/liraglutide (IDegLira) once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 milligrams \\[mg\\] liraglutide) initially. The dose was then escalated twice weekly until the fasting plasma glucose (FPG) target between 4.0-5.0 millimoles per liter (mmol/L) (72-90 milligrams per deciliter \\[mg/dL\\]) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"FG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"506"},{"groupId":"FG001","numSubjects":"506"}]},{"type":"Exposed","achievements":[{"groupId":"FG000","numSubjects":"506"},{"groupId":"FG001","numSubjects":"504"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"484"},{"groupId":"FG001","numSubjects":"481"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"25"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"6"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"15"}]},{"type":"Other","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Full analysis set (FAS) included all randomised participants.","groups":[{"id":"BG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"BG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"506"},{"groupId":"BG001","value":"506"},{"groupId":"BG002","value":"1012"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"56.8","spread":"10.0"},{"groupId":"BG001","value":"56.4","spread":"10.1"},{"groupId":"BG002","value":"56.6","spread":"10.0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"226"},{"groupId":"BG001","value":"231"},{"groupId":"BG002","value":"457"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"280"},{"groupId":"BG001","value":"275"},{"groupId":"BG002","value":"555"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"115"},{"groupId":"BG001","value":"126"},{"groupId":"BG002","value":"241"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"391"},{"groupId":"BG001","value":"380"},{"groupId":"BG002","value":"771"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"White","categories":[{"measurements":[{"groupId":"BG000","value":"424"},{"groupId":"BG001","value":"414"},{"groupId":"BG002","value":"838"}]}]},{"title":"Black or African American","categories":[{"measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"28"},{"groupId":"BG002","value":"53"}]}]},{"title":"Asian","categories":[{"measurements":[{"groupId":"BG000","value":"54"},{"groupId":"BG001","value":"61"},{"groupId":"BG002","value":"115"}]}]},{"title":"Other","categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"6"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification","description":"Inadequate glycaemic control and need for treatment intensification was defined as a glycosylated haemoglobin (HbA1c) of 7.0% or greater at 2 consecutive visits from week 26, including week 26 if HbA1c was greater than or equal to 7% at week 12. Time from randomisation to inadequate glycaemic control and need for treatment intensification was analysed using a stratified log-rank test where treatment, baseline HbA1c group and previous OAD treatment were included as strata in the model. The variable \"baseline HbA1c group\" was a dichotomised baseline HbA1c variable with 2 categories: HbA1c \\< 8.5% or HbA1c ≥ 8.5% and the variable \"previous OAD treatment\" was a categorical variable with 2 categories: SU ± OAD(s) (SU users) or OAD(s) (Non-SU users). 25%, median (50%) and 75% percentiles for the cumulative distribution function were obtained from the Kaplan-Meier survival function.","populationDescription":"FAS included all randomised participants. Number analyzed=participants in the specified category.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"Weeks","timeFrame":"Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"506"}]}],"classes":[{"title":"Baseline HbA1c <8.5% + Non-SU users","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"112"},{"groupId":"OG001","value":"105"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"NA","lowerLimit":"104.0","upperLimit":"NA","comment":"The estimated median and 75 percentile data were not available as the proportions were not reached within study period."},{"groupId":"OG001","value":"104.3","lowerLimit":"38.1","upperLimit":"NA","comment":"The 75 percentile data was not available as the proportions was not reached within study period."}]}]},{"title":"Baseline HbA1c <8.5% + SU users","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"185"},{"groupId":"OG001","value":"135"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"106.7","lowerLimit":"89.9","upperLimit":"NA","comment":"The 75 percentile data was not available as the proportions was not reached within study period."},{"groupId":"OG001","value":"90.3","lowerLimit":"26.4","upperLimit":"105.1"}]}]},{"title":"Baseline HbA1c >=8.5% + Non-SU users","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"67"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"NA","lowerLimit":"39.7","upperLimit":"NA","comment":"The estimated median and 75 percentile data were not available as the proportions were not reached within study period."},{"groupId":"OG001","value":"64.6","lowerLimit":"26.1","upperLimit":"105.1"}]}]},{"title":"Baseline HbA1c >=8.5% + SU users","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"135"},{"groupId":"OG001","value":"199"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"104.0","lowerLimit":"26.4","upperLimit":"NA","comment":"The 75 percentile data was not available as the proportions was not reached within study period."},{"groupId":"OG001","value":"26.6","lowerLimit":"26.1","upperLimit":"91.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Test for no treatment difference was based on using a stratified log-rank test where treatment, baseline HbA1c group and pre-trial OAD treatment group were included as strata in the model.","nonInferiorityType":"OTHER","pValue":"<.0001","statisticalMethod":"Stratified log-rank test"}]},{"type":"SECONDARY","title":"Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits","description":"Time to HbA1c \\> 6.5% at 2 consecutive visits is defined as time from randomization to HbA1c \\> 6.5% at 2 consecutive planned scheduled visits from week 26 (including week 26 if HbA1c was \\> 6.5% at week 12). Time from randomisation to HbA1c \\>6.5% at 2 consecutive visits was analysed using a stratified log-rank test where treatment, baseline HbA1c group and previous OAD treatment were included as strata in the model. The variable \"baseline HbA1c group\" was a dichotomised baseline HbA1c variable with 2 categories: HbA1c \\< 8.5% or HbA1c ≥ 8.5% and the variable \"previous OAD treatment\" was a categorical variable with 2 categories: SU ± OAD(s) (SU users) or OAD(s) (Non-SU users). 25%, median (50%) and 75% percentiles for the cumulative distribution function were obtained from the Kaplan-Meier survival function.","populationDescription":"FAS included all randomised participants. Number analyzed=participants with event.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"Weeks","timeFrame":"Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"506"}]}],"classes":[{"title":"Baseline HbA1c <8.5% + Non-SU users","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"112"},{"groupId":"OG001","value":"105"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"NA","lowerLimit":"52.1","upperLimit":"NA","comment":"The estimated median and 75 percentile data were not available as the proportions were not reached within study period."},{"groupId":"OG001","value":"64.1","lowerLimit":"26.1","upperLimit":"104.3"}]}]},{"title":"Baseline HbA1c <8.5% + SU users","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"185"},{"groupId":"OG001","value":"135"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"90.1","lowerLimit":"27.0","upperLimit":"NA","comment":"The 75 percentile data was not available as the proportion was not reached within study period."},{"groupId":"OG001","value":"26.6","lowerLimit":"26.1","upperLimit":"89.9"}]}]},{"title":"Baseline HbA1c >=8.5% + Non-SU users","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"67"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"64.1","lowerLimit":"26.1","upperLimit":"NA","comment":"The 75 percentile data was not available as the proportion was not reached within study period."},{"groupId":"OG001","value":"26.6","lowerLimit":"26.1","upperLimit":"90.1"}]}]},{"title":"Baseline HbA1c >=8.5% + SU users","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"135"},{"groupId":"OG001","value":"199"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"52.1","lowerLimit":"26.1","upperLimit":"104.1"},{"groupId":"OG001","value":"26.1","lowerLimit":"26.1","upperLimit":"38.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Test for no treatment difference was based on using a stratified log-rank test where treatment, baseline HbA1c group and pre-trial OAD treatment group were included as strata in the model.","nonInferiorityType":"OTHER","pValue":"<.0001","statisticalMethod":"Stratified log-rank test"}]},{"type":"SECONDARY","title":"Change in HbA1c","description":"Change in HbA1c from baseline (week 0) to week 26 is presented.","populationDescription":"FAS included all randomised participants. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Week 0, week 26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"506"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.99","spread":"1.14"},{"groupId":"OG001","value":"-1.69","spread":"1.10"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight","description":"Change in body weight from baseline (week 0) to week 26 and week 104 is presented.","populationDescription":"FAS included all randomised participants. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilogram (kg)","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"506"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"481"},{"groupId":"OG001","value":"466"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.5","spread":"3.3"},{"groupId":"OG001","value":"2.2","spread":"3.6"}]}]},{"title":"Week 104","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"335"},{"groupId":"OG001","value":"190"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.2","spread":"4.9"},{"groupId":"OG001","value":"3.0","spread":"4.9"}]}]}]},{"type":"SECONDARY","title":"Insulin Dose","description":"Insulin dose after 26 and 104 weeks of treatment is presented.","populationDescription":"Safety analysis set (SAS) included all participants receiving at least 1 dose of the investigational product (IDegLira) or comparator (IGlar). 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units","timeFrame":"Week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"476"},{"groupId":"OG001","value":"449"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"34.6","spread":"13.4"},{"groupId":"OG001","value":"48.6","spread":"28.2"}]}]},{"title":"Week 104","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"329"},{"groupId":"OG001","value":"186"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"36.1","spread":"12.9"},{"groupId":"OG001","value":"50.6","spread":"31.5"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved (Yes/no): HbA1c <7.0%","description":"Percentage of participants who achieved (yes/no) HbA1c \\<7.0% at week 26 and week 104 is presented.","populationDescription":"FAS included all randomised participants. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"506"}]}],"classes":[{"title":"Week 26: Yes","categories":[{"measurements":[{"groupId":"OG000","value":"78.7"},{"groupId":"OG001","value":"55.7"}]}]},{"title":"Week 26: No","categories":[{"measurements":[{"groupId":"OG000","value":"21.3"},{"groupId":"OG001","value":"44.3"}]}]},{"title":"Week 104: Yes","categories":[{"measurements":[{"groupId":"OG000","value":"55.5"},{"groupId":"OG001","value":"28.5"}]}]},{"title":"Week 104: No","categories":[{"measurements":[{"groupId":"OG000","value":"44.5"},{"groupId":"OG001","value":"71.5"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain","description":"Percentage of participants who achieved (yes/no) HbA1c \\<7.0% without weight gain at week 26 and week 104 is presented.","populationDescription":"FAS included all randomised participants. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"506"}]}],"classes":[{"title":"Week 26: Yes","categories":[{"measurements":[{"groupId":"OG000","value":"38.5"},{"groupId":"OG001","value":"15.4"}]}]},{"title":"Week 26: No","categories":[{"measurements":[{"groupId":"OG000","value":"61.5"},{"groupId":"OG001","value":"84.6"}]}]},{"title":"Week 104: Yes","categories":[{"measurements":[{"groupId":"OG000","value":"20.9"},{"groupId":"OG001","value":"6.3"}]}]},{"title":"Week 104: No","categories":[{"measurements":[{"groupId":"OG000","value":"79.1"},{"groupId":"OG001","value":"93.7"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes","description":"Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) 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. Percentage of participants who achieved (yes/no) HbA1c \\<7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes at week 26 and week 104 is presented.","populationDescription":"FAS included all randomised participants. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"506"}]}],"classes":[{"title":"Week 26: Yes","categories":[{"measurements":[{"groupId":"OG000","value":"71.3"},{"groupId":"OG001","value":"44.9"}]}]},{"title":"Week 26: No","categories":[{"measurements":[{"groupId":"OG000","value":"28.7"},{"groupId":"OG001","value":"55.1"}]}]},{"title":"Week 104: Yes","categories":[{"measurements":[{"groupId":"OG000","value":"51.8"},{"groupId":"OG001","value":"25.5"}]}]},{"title":"Week 104: No","categories":[{"measurements":[{"groupId":"OG000","value":"48.2"},{"groupId":"OG001","value":"74.5"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain","description":"Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the ADA classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) 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. Percentage of participants who achieved (yes/no) HbA1c \\<7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and without weight gain at week 26 and week 104 is presented.","populationDescription":"FAS included all randomised participants. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"506"}]}],"classes":[{"title":"Week 26: Yes","categories":[{"measurements":[{"groupId":"OG000","value":"35.2"},{"groupId":"OG001","value":"13.6"}]}]},{"title":"Week 26: No","categories":[{"measurements":[{"groupId":"OG000","value":"64.8"},{"groupId":"OG001","value":"86.4"}]}]},{"title":"Week 104: Yes","categories":[{"measurements":[{"groupId":"OG000","value":"20.0"},{"groupId":"OG001","value":"6.1"}]}]},{"title":"Week 104: No","categories":[{"measurements":[{"groupId":"OG000","value":"80.0"},{"groupId":"OG001","value":"93.9"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved (Yes/no): HbA1c ≤6.5%","description":"Percentage of participants who achieved (yes/no) HbA1c ≤6.5% at week 26 and week 104 is presented.","populationDescription":"FAS included all randomised participants. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"506"}]}],"classes":[{"title":"Week 26: Yes","categories":[{"measurements":[{"groupId":"OG000","value":"63.6"},{"groupId":"OG001","value":"35.4"}]}]},{"title":"Week 26: No","categories":[{"measurements":[{"groupId":"OG000","value":"36.4"},{"groupId":"OG001","value":"64.6"}]}]},{"title":"Week 104: Yes","categories":[{"measurements":[{"groupId":"OG000","value":"43.3"},{"groupId":"OG001","value":"21.7"}]}]},{"title":"Week 104: No","categories":[{"measurements":[{"groupId":"OG000","value":"56.7"},{"groupId":"OG001","value":"78.3"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain","description":"Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without weight gain at week 26 and week 104 is presented.","populationDescription":"FAS included all randomised participants. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"506"}]}],"classes":[{"title":"Week 26: Yes","categories":[{"measurements":[{"groupId":"OG000","value":"33.2"},{"groupId":"OG001","value":"9.9"}]}]},{"title":"Week 26: No","categories":[{"measurements":[{"groupId":"OG000","value":"66.8"},{"groupId":"OG001","value":"90.1"}]}]},{"title":"Week 104: Yes","categories":[{"measurements":[{"groupId":"OG000","value":"17.6"},{"groupId":"OG001","value":"5.7"}]}]},{"title":"Week 104: No","categories":[{"measurements":[{"groupId":"OG000","value":"82.4"},{"groupId":"OG001","value":"94.3"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes","description":"Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) 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. Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes at week 26 and week 104 is presented.","populationDescription":"FAS included all randomised participants. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"506"}]}],"classes":[{"title":"Week 26: Yes","categories":[{"measurements":[{"groupId":"OG000","value":"57.9"},{"groupId":"OG001","value":"27.9"}]}]},{"title":"Week 26: No","categories":[{"measurements":[{"groupId":"OG000","value":"42.1"},{"groupId":"OG001","value":"72.1"}]}]},{"title":"Week 104: Yes","categories":[{"measurements":[{"groupId":"OG000","value":"40.1"},{"groupId":"OG001","value":"19.2"}]}]},{"title":"Week 104: No","categories":[{"measurements":[{"groupId":"OG000","value":"59.9"},{"groupId":"OG001","value":"80.8"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain","description":"Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) 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. Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and without weight gain at week 26 and week 104 is presented.","populationDescription":"FAS included all randomised participants. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"506"}]}],"classes":[{"title":"Week 26: Yes","categories":[{"measurements":[{"groupId":"OG000","value":"30.2"},{"groupId":"OG001","value":"8.7"}]}]},{"title":"Week 26: No","categories":[{"measurements":[{"groupId":"OG000","value":"69.8"},{"groupId":"OG001","value":"91.3"}]}]},{"title":"Week 104: Yes","categories":[{"measurements":[{"groupId":"OG000","value":"16.6"},{"groupId":"OG001","value":"5.5"}]}]},{"title":"Week 104: No","categories":[{"measurements":[{"groupId":"OG000","value":"83.4"},{"groupId":"OG001","value":"94.5"}]}]}]},{"type":"SECONDARY","title":"Change in FPG","description":"Change in fasting plasma glucose (FPG) from baseline (week 0) to week 26 and week 104 is presented.","populationDescription":"FAS included all randomised participants. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"506"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"475"},{"groupId":"OG001","value":"461"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-3.97","spread":"3.06"},{"groupId":"OG001","value":"-3.79","spread":"3.18"}]}]},{"title":"Week 104","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"328"},{"groupId":"OG001","value":"185"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-3.93","spread":"2.96"},{"groupId":"OG001","value":"-3.73","spread":"2.75"}]}]}]},{"type":"SECONDARY","title":"SMPG-9-point Profile (Individual Points in the Profile)","description":"Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Self-measured plasma glucose (SMPG)-9-point profile (individual points in the profile) at week 26 and week 104 is presented.","populationDescription":"FAS included all randomised participants. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"506"}]}],"classes":[{"title":"Week 26: Before breakfast","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"437"},{"groupId":"OG001","value":"413"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.59","spread":"1.57"},{"groupId":"OG001","value":"5.58","spread":"1.58"}]}]},{"title":"Week 26: 90 minutes after breakfast","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"425"},{"groupId":"OG001","value":"409"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"8.34","spread":"2.62"},{"groupId":"OG001","value":"8.76","spread":"2.68"}]}]},{"title":"Week 26: Before lunch","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"435"},{"groupId":"OG001","value":"407"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6.03","spread":"2.00"},{"groupId":"OG001","value":"6.43","spread":"2.24"}]}]},{"title":"Week 26: 90 minutes after lunch","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"433"},{"groupId":"OG001","value":"407"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"8.02","spread":"2.32"},{"groupId":"OG001","value":"8.79","spread":"2.64"}]}]},{"title":"Week 26: Before dinner","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"434"},{"groupId":"OG001","value":"408"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6.67","spread":"2.26"},{"groupId":"OG001","value":"6.91","spread":"2.35"}]}]},{"title":"Week 26: 90 minutes after dinner","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"428"},{"groupId":"OG001","value":"406"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"8.31","spread":"2.47"},{"groupId":"OG001","value":"9.10","spread":"2.70"}]}]},{"title":"Week 26: Bedtime","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"423"},{"groupId":"OG001","value":"398"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"7.48","spread":"2.42"},{"groupId":"OG001","value":"8.13","spread":"2.68"}]}]},{"title":"Week 26: At 4:00 a.m.","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"419"},{"groupId":"OG001","value":"398"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.72","spread":"1.55"},{"groupId":"OG001","value":"5.91","spread":"1.99"}]}]},{"title":"Week 26: Before breakfast the following day","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"433"},{"groupId":"OG001","value":"403"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.53","spread":"1.37"},{"groupId":"OG001","value":"5.56","spread":"1.56"}]}]},{"title":"Week 104: Before breakfast","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"296"},{"groupId":"OG001","value":"171"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.58","spread":"1.38"},{"groupId":"OG001","value":"5.57","spread":"1.27"}]}]},{"title":"Week 104: 90 minutes after breakfast","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"287"},{"groupId":"OG001","value":"166"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"7.99","spread":"2.50"},{"groupId":"OG001","value":"8.64","spread":"2.59"}]}]},{"title":"Week 104: Before lunch","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"290"},{"groupId":"OG001","value":"167"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6.06","spread":"1.91"},{"groupId":"OG001","value":"6.37","spread":"2.02"}]}]},{"title":"Week 104: 90 minutes after lunch","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"290"},{"groupId":"OG001","value":"167"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"7.80","spread":"2.16"},{"groupId":"OG001","value":"8.87","spread":"2.45"}]}]},{"title":"Week 104: Before dinner","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"292"},{"groupId":"OG001","value":"168"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6.58","spread":"1.97"},{"groupId":"OG001","value":"7.02","spread":"2.45"}]}]},{"title":"Week 104: 90 minutes after dinner","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"290"},{"groupId":"OG001","value":"167"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"8.20","spread":"2.20"},{"groupId":"OG001","value":"9.10","spread":"2.61"}]}]},{"title":"Week 104: Bedtime","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"286"},{"groupId":"OG001","value":"164"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"7.47","spread":"2.17"},{"groupId":"OG001","value":"7.90","spread":"2.41"}]}]},{"title":"Week 104: At 4:00 a.m.","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"284"},{"groupId":"OG001","value":"163"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.67","spread":"1.35"},{"groupId":"OG001","value":"5.96","spread":"1.73"}]}]},{"title":"Week 104: Before breakfast the following day","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"292"},{"groupId":"OG001","value":"169"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.44","spread":"1.23"},{"groupId":"OG001","value":"5.47","spread":"1.35"}]}]}]},{"type":"SECONDARY","title":"Change in SMPG-mean 9-point Profile","description":"Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Change in SMPG-mean 9-point profile from baseline (week 0) to week 26 and week 104 is presented.","populationDescription":"FAS included all randomised participants. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"506"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"422"},{"groupId":"OG001","value":"389"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-3.34","spread":"2.46"},{"groupId":"OG001","value":"-3.32","spread":"2.62"}]}]},{"title":"Week 104","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"161"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-3.27","spread":"2.36"},{"groupId":"OG001","value":"-2.76","spread":"2.41"}]}]}]},{"type":"SECONDARY","title":"Change in SMPG-mean Postprandial Increment Over All Meals","description":"Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Change in SMPG-mean postprandial increment over all meals from baseline (week 0) to week 26 and week 104 is presented.","populationDescription":"FAS included all randomised participants. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"506"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"428"},{"groupId":"OG001","value":"405"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.28","spread":"2.13"},{"groupId":"OG001","value":"0.20","spread":"2.17"}]}]},{"title":"Week 104","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"286"},{"groupId":"OG001","value":"164"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.47","spread":"1.99"},{"groupId":"OG001","value":"0.12","spread":"2.17"}]}]}]},{"type":"SECONDARY","title":"Change in Blood Pressure (Systolic and Diastolic)","description":"Change in blood pressure (systolic and diastolic) from baseline (week 0) to week 26 and week 104 is presented.","populationDescription":"FAS included all randomised participants. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimeters of mercury (mmHg)","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"506"}]}],"classes":[{"title":"Week 26: Systolic blood pressure","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"482"},{"groupId":"OG001","value":"466"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.2","spread":"14.0"},{"groupId":"OG001","value":"0.5","spread":"13.1"}]}]},{"title":"Week 26: Diastolic blood pressure","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"482"},{"groupId":"OG001","value":"466"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.1","spread":"8.8"},{"groupId":"OG001","value":"-0.3","spread":"8.4"}]}]},{"title":"Week 104: Systolic blood pressure","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"335"},{"groupId":"OG001","value":"190"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.5","spread":"14.3"},{"groupId":"OG001","value":"0.9","spread":"13.6"}]}]},{"title":"Week 104: Diastolic blood pressure","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"335"},{"groupId":"OG001","value":"190"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.1","spread":"8.8"},{"groupId":"OG001","value":"-0.2","spread":"8.6"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting C-peptide","description":"Change in fasting C-peptide (measured in nanomoles per liter \\[nmol/L\\]) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.","populationDescription":"FAS included all randomised participants. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of C-peptide","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"506"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"474"},{"groupId":"OG001","value":"458"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.63","spread":"60.79"},{"groupId":"OG001","value":"0.57","spread":"62.44"}]}]},{"title":"Week 104","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"333"},{"groupId":"OG001","value":"184"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.58","spread":"64.21"},{"groupId":"OG001","value":"0.54","spread":"70.45"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Human Insulin","description":"Change in fasting human insulin (measured in picomoles per liter \\[pmol/L\\]) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.","populationDescription":"FAS included all randomised participants. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of insulin","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"506"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"478"},{"groupId":"OG001","value":"456"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.67","spread":"90.68"},{"groupId":"OG001","value":"0.68","spread":"89.19"}]}]},{"title":"Week 104","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"330"},{"groupId":"OG001","value":"186"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.60","spread":"91.84"},{"groupId":"OG001","value":"0.62","spread":"92.55"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Total Cholesterol","description":"Change in fasting total cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.","populationDescription":"FAS included all randomised participants. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of total cholesterol","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"506"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"470"},{"groupId":"OG001","value":"455"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"17.38"},{"groupId":"OG001","value":"0.99","spread":"17.68"}]}]},{"title":"Week 104","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"319"},{"groupId":"OG001","value":"181"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.97","spread":"19.11"},{"groupId":"OG001","value":"0.97","spread":"20.40"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting LDL-cholesterol","description":"Change in fasting low density lipoprotein (LDL)-cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.","populationDescription":"FAS included all randomised participants. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of LDL-cholesterol","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"506"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"467"},{"groupId":"OG001","value":"452"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.05","spread":"35.97"},{"groupId":"OG001","value":"1.02","spread":"30.10"}]}]},{"title":"Week 104","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"178"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.96","spread":"38.83"},{"groupId":"OG001","value":"0.98","spread":"34.40"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting HDL-cholesterol","description":"Change in fasting high density lipoprotein (HDL)- cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.","populationDescription":"FAS included all randomised participants. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of HDL-cholesterol","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"506"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"467"},{"groupId":"OG001","value":"454"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.03","spread":"16.61"},{"groupId":"OG001","value":"1.02","spread":"15.57"}]}]},{"title":"Week 104","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"319"},{"groupId":"OG001","value":"180"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.02","spread":"16.93"},{"groupId":"OG001","value":"1.03","spread":"17.36"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting VLDL-cholesterol","description":"Change in fasting very low density lipoprotein (VLDL)-cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.","populationDescription":"FAS included all randomised participants. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of VLDL-cholesterol","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"506"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"468"},{"groupId":"OG001","value":"453"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.85","spread":"40.78"},{"groupId":"OG001","value":"0.85","spread":"42.01"}]}]},{"title":"Week 104","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"179"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.90","spread":"40.90"},{"groupId":"OG001","value":"0.88","spread":"35.98"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Triglycerides","description":"Change in fasting triglycerides (measured as mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.","populationDescription":"FAS included all randomised participants. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of triglycerides","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"506"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"469"},{"groupId":"OG001","value":"455"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.84","spread":"43.82"},{"groupId":"OG001","value":"0.85","spread":"45.75"}]}]},{"title":"Week 104","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"319"},{"groupId":"OG001","value":"181"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.89","spread":"42.20"},{"groupId":"OG001","value":"0.89","spread":"40.08"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Free Fatty Acids","description":"Change in fasting free fatty acids (measured as mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.","populationDescription":"FAS included all randomised participants. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of free fatty acids","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"506"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"474"},{"groupId":"OG001","value":"460"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.68","spread":"59.69"},{"groupId":"OG001","value":"0.75","spread":"60.25"}]}]},{"title":"Week 104","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"332"},{"groupId":"OG001","value":"186"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.70","spread":"57.71"},{"groupId":"OG001","value":"0.78","spread":"59.48"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment","description":"Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) 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. Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during 26 weeks of treatment is presented.","populationDescription":"SAS included all participants receiving at least 1 dose of the investigational product or comparator.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"Weeks 0-26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"143"},{"groupId":"OG001","value":"261"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment","description":"Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) 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. Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during 104 weeks of treatment is presented.","populationDescription":"SAS included all participants receiving at least 1 dose of the investigational product or comparator.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"Weeks 0-104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"319"},{"groupId":"OG001","value":"642"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment Emergent Hypoglycaemic Episodes During 26 Weeks of Treatment","description":"Hypoglycaemic episodes (SMPG value ≤3.9 mmol/L (70 mg/dL)) 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 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 treatment-emergent hypoglycaemic episodes according to ADA during 26 weeks of treatment is presented.","populationDescription":"SAS included all participants receiving at least 1 dose of the investigational product or comparator.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"Weeks 0-26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3190"},{"groupId":"OG001","value":"3806"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment Emergent Hypoglycaemic Episodes During 104 Weeks of Treatment","description":"Hypoglycaemic episodes (SMPG value ≤3.9 mmol/L (70 mg/dL)) 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 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 treatment emergent hypoglycaemic episodes according to ADA during 104 weeks of treatment is presented.","populationDescription":"SAS included all participants receiving at least 1 dose of the investigational product or comparator.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"Weeks 0-104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8934"},{"groupId":"OG001","value":"10658"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment","description":"Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 both inclusive. 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 treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes during 26 weeks of treatment is presented.","populationDescription":"SAS included all participants receiving at least 1 dose of the investigational product or comparator.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"Weeks 0-26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"60"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment","description":"Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 both inclusive. 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 treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes during 104 weeks of treatment is presented.","populationDescription":"SAS included all participants receiving at least 1 dose of the investigational product or comparator.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"Weeks 0-104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"164"}]}]}]},{"type":"SECONDARY","title":"Number of TEAEs During 26 Weeks of Treatment","description":"An adverse event is any untoward medical occurrence in a participant administered a product, and which does not necessarily have a causal relationship with this treatment. A treatment emergent adverse event (TEAE) was defined as an adverse event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product. If the event had onset date before the first day of exposure on trial product and increased in severity during the treatment period and until 7 days after the last drug date, then this event was also considered as a TEAE. Number of TEAEs during 26 weeks of treatment is presented.","populationDescription":"SAS included all participants receiving at least 1 dose of the investigational product or comparator.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Adverse events","timeFrame":"Weeks 0-26","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"718"},{"groupId":"OG001","value":"624"}]}]}]},{"type":"SECONDARY","title":"Number of TEAEs During 104 Weeks of Treatment","description":"An adverse event is any untoward medical occurrence in a participant administered a product, and which does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product. If the event had onset date before the first day of exposure on trial product and increased in severity during the treatment period and until 7 days after the last drug date, then this event was also considered as a TEAE. Number of TEAEs during 104 weeks of treatment is presented.","populationDescription":"SAS included all participants receiving at least 1 dose of the investigational product or comparator.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Adverse events","timeFrame":"Week 0 to week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1788"},{"groupId":"OG001","value":"1368"}]}]}]},{"type":"SECONDARY","title":"Eye Examination Category","description":"Fundus photography or a dilated fundoscopy was performed at baseline (within 12 weeks prior to week 0) and week 104. The investigator interpreted each eye's (left and right) results and categorised them as: normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). Number of participants in each category at baseline and week 104 were presented.","populationDescription":"SAS included all participants receiving at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Baseline (within 12 weeks prior to week 0), week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"classes":[{"title":"Left eye: Normal (baseline)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"345"},{"groupId":"OG001","value":"341"}]}]},{"title":"Left eye: Abnormal NCS (baseline)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"151"},{"groupId":"OG001","value":"155"}]}]},{"title":"Left eye: Abnormal CS (baseline)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"8"}]}]},{"title":"Left eye: Normal (week 104)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"185"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"204"},{"groupId":"OG001","value":"129"}]}]},{"title":"Left eye: Abnormal NCS (week 104)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"185"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"50"}]}]},{"title":"Left eye: Abnormal CS (week 104)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"185"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"6"}]}]},{"title":"Right eye: Normal (baseline)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"344"},{"groupId":"OG001","value":"355"}]}]},{"title":"Right eye: Abnormal NCS (baseline)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"151"},{"groupId":"OG001","value":"143"}]}]},{"title":"Right eye: Abnormal CS (baseline)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"6"}]}]},{"title":"Right eye: Normal (week 104)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"185"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"200"},{"groupId":"OG001","value":"132"}]}]},{"title":"Right eye: Abnormal NCS (week 104)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"185"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"99"},{"groupId":"OG001","value":"48"}]}]},{"title":"Right eye: Abnormal CS (week 104)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"185"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"5"}]}]}]},{"type":"SECONDARY","title":"ECG Evaluation","description":"The electrocardiogram (ECG) was assessed at baseline (within 2 weeks prior to week 0) and week 104. The investigator interpreted the results and categorised them as: normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 104 are presented.","populationDescription":"SAS included all participants receiving at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Baseline (within 2 weeks prior to week 0), week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"classes":[{"title":"Normal (Baseline)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"335"},{"groupId":"OG001","value":"335"}]}]},{"title":"Abnormal NCS (Baseline)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"162"},{"groupId":"OG001","value":"165"}]}]},{"title":"Abnormal CS (Baseline)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"4"}]}]},{"title":"Normal (week 104)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"331"},{"groupId":"OG001","value":"189"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"227"},{"groupId":"OG001","value":"122"}]}]},{"title":"Abnormal NCS (week 104)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"331"},{"groupId":"OG001","value":"189"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"65"}]}]},{"title":"Abnormal CS (week 104)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"331"},{"groupId":"OG001","value":"189"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"2"}]}]}]},{"type":"SECONDARY","title":"Change in Urine Albumin/Creatinine Ratio","description":"Change in urine albumin/creatinine ratio from baseline (week 0) to week 104 is presented.","populationDescription":"SAS included all participants receiving at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Milligrams per millimole (mg/mmol)","timeFrame":"Week 0, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.09","spread":"7.43"},{"groupId":"OG001","value":"-0.74","spread":"15.58"}]}]}]},{"type":"SECONDARY","title":"Change in Pulse Rate","description":"Change in pulse rate from baseline (week 0) to week 26 and week 104 is presented.","populationDescription":"SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Beats per minute","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"482"},{"groupId":"OG001","value":"466"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.0","spread":"8.8"},{"groupId":"OG001","value":"-0.4","spread":"8.7"}]}]},{"title":"Week 104","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"335"},{"groupId":"OG001","value":"189"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.7","spread":"9.3"},{"groupId":"OG001","value":"-0.5","spread":"9.7"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry Parameter- Creatinine, Total Bilirubin","description":"Change in biochemistry parameter- creatinine, total bilirubin from baseline (week 0) to week 26 and week 104 is presented.","populationDescription":"SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Micromoles per liter (umol/L)","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"classes":[{"title":"Week 26: creatinine","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"476"},{"groupId":"OG001","value":"462"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.50","spread":"10.08"},{"groupId":"OG001","value":"0.25","spread":"8.78"}]}]},{"title":"Week 104: creatinine","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"325"},{"groupId":"OG001","value":"184"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.75","spread":"10.85"},{"groupId":"OG001","value":"2.20","spread":"11.86"}]}]},{"title":"Week 26: total bilirubin","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"476"},{"groupId":"OG001","value":"462"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.30","spread":"3.35"},{"groupId":"OG001","value":"-0.32","spread":"2.80"}]}]},{"title":"Week 104: total bilirubin","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"324"},{"groupId":"OG001","value":"182"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.33","spread":"3.42"},{"groupId":"OG001","value":"-0.59","spread":"3.01"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry Parameter- Albumin","description":"Change in biochemistry parameter- albumin from baseline (week 0) to week 26 and week 104 is presented.","populationDescription":"SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Grams per deciliter (g/dL)","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"477"},{"groupId":"OG001","value":"462"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.03","spread":"0.24"},{"groupId":"OG001","value":"-0.03","spread":"0.21"}]}]},{"title":"Week 104","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"324"},{"groupId":"OG001","value":"184"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.01","spread":"0.24"},{"groupId":"OG001","value":"0.03","spread":"0.27"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase","description":"Change in biochemistry parameters- alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lipase and amylase from baseline (week 0) to week 26 and week 104 is presented.","populationDescription":"SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units per liter (U/L)","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"classes":[{"title":"Week 26: ALP","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"476"},{"groupId":"OG001","value":"462"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-4.16","spread":"14.16"},{"groupId":"OG001","value":"-4.33","spread":"12.84"}]}]},{"title":"Week 104: ALP","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"324"},{"groupId":"OG001","value":"183"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.35","spread":"15.71"},{"groupId":"OG001","value":"-1.34","spread":"14.22"}]}]},{"title":"Week 26: ALT","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"476"},{"groupId":"OG001","value":"462"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-5.45","spread":"18.50"},{"groupId":"OG001","value":"-3.33","spread":"13.24"}]}]},{"title":"Week 104: ALT","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"323"},{"groupId":"OG001","value":"184"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-5.39","spread":"14.16"},{"groupId":"OG001","value":"-3.45","spread":"14.46"}]}]},{"title":"Week 26: AST","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"476"},{"groupId":"OG001","value":"462"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.62","spread":"9.78"},{"groupId":"OG001","value":"-0.39","spread":"9.51"}]}]},{"title":"Week 104: AST","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"323"},{"groupId":"OG001","value":"182"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.84","spread":"9.86"},{"groupId":"OG001","value":"-0.67","spread":"10.78"}]}]},{"title":"Week 26: lipase","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"476"},{"groupId":"OG001","value":"462"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"9.26","spread":"42.92"},{"groupId":"OG001","value":"-7.97","spread":"34.28"}]}]},{"title":"Week 104: lipase","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"325"},{"groupId":"OG001","value":"184"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.41","spread":"48.35"},{"groupId":"OG001","value":"-13.33","spread":"42.27"}]}]},{"title":"Week 26: amylase","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"477"},{"groupId":"OG001","value":"462"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"9.72","spread":"23.28"},{"groupId":"OG001","value":"2.79","spread":"20.92"}]}]},{"title":"Week 104: amylase","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"325"},{"groupId":"OG001","value":"184"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"7.23","spread":"25.42"},{"groupId":"OG001","value":"-0.13","spread":"25.94"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry Parameter- Sodium, Potassium and Calcium","description":"Change in sodium, potassium and calcium from baseline (week 0) to week 26 and week 104 is presented.","populationDescription":"SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"classes":[{"title":"Week 26: sodium","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"477"},{"groupId":"OG001","value":"462"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.89","spread":"2.74"},{"groupId":"OG001","value":"1.03","spread":"2.61"}]}]},{"title":"Week 104: sodium","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"325"},{"groupId":"OG001","value":"184"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.22","spread":"2.54"},{"groupId":"OG001","value":"1.47","spread":"2.39"}]}]},{"title":"Week 26: potassium","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"477"},{"groupId":"OG001","value":"461"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.05","spread":"0.40"},{"groupId":"OG001","value":"-0.08","spread":"0.42"}]}]},{"title":"Week 104: potassium","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"324"},{"groupId":"OG001","value":"184"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.06","spread":"0.42"},{"groupId":"OG001","value":"-0.07","spread":"0.43"}]}]},{"title":"Week 26: calcium","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"475"},{"groupId":"OG001","value":"462"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.01","spread":"0.11"},{"groupId":"OG001","value":"-0.00","spread":"0.11"}]}]},{"title":"Week 104: calcium","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"323"},{"groupId":"OG001","value":"184"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.07","spread":"0.10"},{"groupId":"OG001","value":"-0.06","spread":"0.11"}]}]}]},{"type":"SECONDARY","title":"Change in Haematological Parameter- Haemoglobin","description":"Change in haemoglobin from baseline (week 0) to week 26 and week 104 is presented.","populationDescription":"SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"g/dL","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"480"},{"groupId":"OG001","value":"463"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.08","spread":"0.72"},{"groupId":"OG001","value":"0.08","spread":"0.74"}]}]},{"title":"Week 104","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"331"},{"groupId":"OG001","value":"185"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.00","spread":"0.89"},{"groupId":"OG001","value":"-0.03","spread":"0.92"}]}]}]},{"type":"SECONDARY","title":"Change in Haematological Parameter- Haematocrit","description":"Change in haematocrit from baseline (week 0) to week 26 and week 104 is presented.","populationDescription":"SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of red blood cells","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"478"},{"groupId":"OG001","value":"462"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.33","spread":"2.45"},{"groupId":"OG001","value":"-0.36","spread":"2.43"}]}]},{"title":"Week 104","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"329"},{"groupId":"OG001","value":"184"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.71","spread":"2.83"},{"groupId":"OG001","value":"-0.95","spread":"3.02"}]}]}]},{"type":"SECONDARY","title":"Change in Haematological Parameter- Erythrocytes","description":"Change in erythrocytes from baseline (week 0) to week 26 and week 104 is presented.","populationDescription":"SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"10^12 cells/L","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"480"},{"groupId":"OG001","value":"464"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.02","spread":"0.28"},{"groupId":"OG001","value":"-0.03","spread":"0.27"}]}]},{"title":"Week 104","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"331"},{"groupId":"OG001","value":"185"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.12","spread":"0.30"},{"groupId":"OG001","value":"-0.11","spread":"0.32"}]}]}]},{"type":"SECONDARY","title":"Change in Haematological Parameter- Thrombocytes and Leukocytes","description":"Change in thrombocytes and leukocytes from baseline (week 0) to week 26 and week 104 is presented.","populationDescription":"SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"10^9 cells/L","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"classes":[{"title":"Week 26: Thrombocytes","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"476"},{"groupId":"OG001","value":"463"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"8.77","spread":"35.82"},{"groupId":"OG001","value":"7.05","spread":"41.71"}]}]},{"title":"Week 104: Thrombocytes","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"184"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"16.87","spread":"39.27"},{"groupId":"OG001","value":"18.73","spread":"53.76"}]}]},{"title":"Week 26: Leukocytes","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"480"},{"groupId":"OG001","value":"464"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.49","spread":"1.45"},{"groupId":"OG001","value":"0.39","spread":"1.43"}]}]},{"title":"Week 104: Leukocytes","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"329"},{"groupId":"OG001","value":"185"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.07","spread":"1.50"},{"groupId":"OG001","value":"0.32","spread":"1.55"}]}]}]},{"type":"SECONDARY","title":"Change in Haematological Parameter- Eosinophils","description":"Change in eosinophils from baseline (week 0) to week 26 and week 104 is presented.","populationDescription":"SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of eosinophils","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"478"},{"groupId":"OG001","value":"464"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.10","spread":"1.88"},{"groupId":"OG001","value":"0.06","spread":"2.09"}]}]},{"title":"Week 104","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"183"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.32","spread":"2.08"},{"groupId":"OG001","value":"0.43","spread":"1.56"}]}]}]},{"type":"SECONDARY","title":"Change in Haematological Parameter- Neutrophils","description":"Change in neutrophils from baseline (week 0) to week 26 and week 104 is presented.","populationDescription":"SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of neutrophils","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"478"},{"groupId":"OG001","value":"464"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.86","spread":"7.20"},{"groupId":"OG001","value":"0.78","spread":"7.68"}]}]},{"title":"Week 104","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"183"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.25","spread":"7.94"},{"groupId":"OG001","value":"1.21","spread":"8.02"}]}]}]},{"type":"SECONDARY","title":"Change in Haematological Parameter- Basophils","description":"Change in basophils from baseline (week 0) to week 26 and week 104 is presented.","populationDescription":"SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of basophils","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"478"},{"groupId":"OG001","value":"464"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.00","spread":"0.28"},{"groupId":"OG001","value":"-0.00","spread":"0.29"}]}]},{"title":"Week 104","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"183"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.20","spread":"0.38"},{"groupId":"OG001","value":"0.16","spread":"0.35"}]}]}]},{"type":"SECONDARY","title":"Change in Haematological Parameter- Monocytes","description":"Change in monocytes from baseline (week 0) to week 26 and week 104 is presented.","populationDescription":"SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of monocytes","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"478"},{"groupId":"OG001","value":"464"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.10","spread":"2.04"},{"groupId":"OG001","value":"0.01","spread":"1.91"}]}]},{"title":"Week 104","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"183"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.49","spread":"2.02"},{"groupId":"OG001","value":"0.59","spread":"1.88"}]}]}]},{"type":"SECONDARY","title":"Change in Haematological Parameter- Lymphocytes","description":"Change in lymphocytes from baseline (week 0) to week 26 and week 104 is presented.","populationDescription":"SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of lymphocytes","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"478"},{"groupId":"OG001","value":"464"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.87","spread":"6.29"},{"groupId":"OG001","value":"-0.84","spread":"6.73"}]}]},{"title":"Week 104","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"183"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2.25","spread":"6.76"},{"groupId":"OG001","value":"-2.38","spread":"7.29"}]}]}]},{"type":"SECONDARY","title":"Change in Calcitonin","description":"The number of participants who reported low, normal and high levels of calcitonin in relation to reference ranges at baseline (week 0), week 26 and week 104 are presented.","populationDescription":"SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"classes":[{"title":"Week 0: Low","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Week 0: Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"481"},{"groupId":"OG001","value":"472"}]}]},{"title":"Week 0: High","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"504"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"32"}]}]},{"title":"Week 26: Low","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"477"},{"groupId":"OG001","value":"461"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Week 26: Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"477"},{"groupId":"OG001","value":"461"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"437"},{"groupId":"OG001","value":"431"}]}]},{"title":"Week 26: High","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"477"},{"groupId":"OG001","value":"461"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"30"}]}]},{"title":"Week 104: Low","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"332"},{"groupId":"OG001","value":"186"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Week 104: Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"332"},{"groupId":"OG001","value":"186"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"301"},{"groupId":"OG001","value":"169"}]}]},{"title":"Week 104: High","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"332"},{"groupId":"OG001","value":"186"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"17"}]}]}]},{"type":"SECONDARY","title":"Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)","description":"SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in the sub-domain scores and component summary (PCS and MCS) scores are presented. A positive change score indicates an improvement since baseline.","populationDescription":"FAS included all randomised participants. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"506"}]}],"classes":[{"title":"Week 26: Physical functioning","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"482"},{"groupId":"OG001","value":"465"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.2","spread":"6.8"},{"groupId":"OG001","value":"1.1","spread":"7.0"}]}]},{"title":"Week 104: Physical functioning","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"335"},{"groupId":"OG001","value":"190"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.7","spread":"7.5"},{"groupId":"OG001","value":"0.6","spread":"7.9"}]}]},{"title":"Week 26: Role-physical","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"482"},{"groupId":"OG001","value":"465"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.4","spread":"7.7"},{"groupId":"OG001","value":"0.5","spread":"7.4"}]}]},{"title":"Week 104: Role-physical","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"335"},{"groupId":"OG001","value":"190"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.4","spread":"8.7"},{"groupId":"OG001","value":"0.7","spread":"7.5"}]}]},{"title":"Week 26: Bodily pain","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"482"},{"groupId":"OG001","value":"465"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.5","spread":"9.7"},{"groupId":"OG001","value":"0.4","spread":"10.0"}]}]},{"title":"Week 104: Bodily pain","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"335"},{"groupId":"OG001","value":"190"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.6","spread":"11.2"},{"groupId":"OG001","value":"0.1","spread":"8.5"}]}]},{"title":"Week 26: General health","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"482"},{"groupId":"OG001","value":"465"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.5","spread":"8.2"},{"groupId":"OG001","value":"2.1","spread":"7.6"}]}]},{"title":"Week 104: General health","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"335"},{"groupId":"OG001","value":"190"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.3","spread":"8.7"},{"groupId":"OG001","value":"2.1","spread":"8.3"}]}]},{"title":"Week 26: Vitality","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"482"},{"groupId":"OG001","value":"465"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.4","spread":"8.1"},{"groupId":"OG001","value":"1.4","spread":"8.0"}]}]},{"title":"Week 104: Vitality","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"335"},{"groupId":"OG001","value":"190"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.5","spread":"8.4"},{"groupId":"OG001","value":"1.5","spread":"8.0"}]}]},{"title":"Week 26: Social functioning","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"482"},{"groupId":"OG001","value":"465"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.8","spread":"8.1"},{"groupId":"OG001","value":"0.9","spread":"8.8"}]}]},{"title":"Week 104: Social functioning","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"335"},{"groupId":"OG001","value":"190"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.9","spread":"8.9"},{"groupId":"OG001","value":"1.1","spread":"7.6"}]}]},{"title":"Week 26: Role-emotional","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"482"},{"groupId":"OG001","value":"465"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.6","spread":"8.9"},{"groupId":"OG001","value":"0.7","spread":"8.8"}]}]},{"title":"Week 104: Role-emotional","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"335"},{"groupId":"OG001","value":"190"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.6","spread":"10.1"},{"groupId":"OG001","value":"1.2","spread":"8.2"}]}]},{"title":"Week 26: Mental health","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"482"},{"groupId":"OG001","value":"465"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.7","spread":"8.7"},{"groupId":"OG001","value":"1.3","spread":"8.4"}]}]},{"title":"Week 104: Mental health","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"335"},{"groupId":"OG001","value":"190"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.5","spread":"9.4"},{"groupId":"OG001","value":"0.3","spread":"8.9"}]}]},{"title":"Week 26: PCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"482"},{"groupId":"OG001","value":"465"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.6","spread":"6.3"},{"groupId":"OG001","value":"0.9","spread":"6.3"}]}]},{"title":"Week 104: PCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"335"},{"groupId":"OG001","value":"190"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.0","spread":"7.2"},{"groupId":"OG001","value":"0.8","spread":"6.0"}]}]},{"title":"Week 26: MCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"482"},{"groupId":"OG001","value":"465"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.3","spread":"8.2"},{"groupId":"OG001","value":"1.2","spread":"8.0"}]}]},{"title":"Week 104: MCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"335"},{"groupId":"OG001","value":"190"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.0","spread":"9.0"},{"groupId":"OG001","value":"1.0","spread":"7.8"}]}]}]},{"type":"SECONDARY","title":"Change in TRIM-D","description":"Treatment related impact measures-diabetes (TRIM-D) was developed according to the FDA guidance from 2009 on development of new PRO measures. The questionnaire consists of 5 sub-domains, which are scored according to a 1-5 point scale with a higher score indicating a better health state (less negative impact). Sub-domain scores are calculated by summing across items in the same sub-domain, and the total score is calculated by summing scores from all the sub-domains. The highest possible summed score within a sub-domain ranges from 20 (compliance sub-domain) to 40 (psychological health sub-domain) points and the highest possible total score is 140 points. Change in TRIM-D total score from baseline (week 0) to week 26 and week 104 is presented. A positive change score indicates an improvement since baseline.","populationDescription":"FAS included all randomised participants. 'Number analyzed'=participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Week 0, week 26, week 104","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide)."},{"id":"OG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"506"},{"groupId":"OG001","value":"506"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"477"},{"groupId":"OG001","value":"456"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"9.6","spread":"12.4"},{"groupId":"OG001","value":"7.3","spread":"13.1"}]}]},{"title":"Week 104","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"332"},{"groupId":"OG001","value":"183"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"11.4","spread":"13.7"},{"groupId":"OG001","value":"9.5","spread":"12.8"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2","description":"All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of trial product.","eventGroups":[{"id":"EG000","title":"Insulin Degludec/Liraglutide","description":"Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).","deathsNumAffected":2,"deathsNumAtRisk":506,"seriousNumAffected":60,"seriousNumAtRisk":506,"otherNumAffected":206,"otherNumAtRisk":506},{"id":"EG001","title":"Insulin Glargine","description":"Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.","deathsNumAffected":5,"deathsNumAtRisk":504,"seriousNumAffected":43,"seriousNumAtRisk":504,"otherNumAffected":156,"otherNumAtRisk":504}],"seriousEvents":[{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":506},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":504}]},{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 21","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":506},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":504}]},{"term":"Angina unstable","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 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