{"protocolSection":{"identificationModule":{"nctId":"NCT02607306","orgStudyIdInfo":{"id":"NN9068-4183"},"secondaryIdInfos":[{"id":"U1111-1170-1332","type":"OTHER","domain":"WHO"},{"id":"JapicCTI-153089","type":"OTHER","domain":"JAPIC"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese Subjects With Type 2 Diabetes Mellitus.","officialTitle":"A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese Subjects With Type 2 Diabetes Mellitus","acronym":"DUAL™ I Japan"},"statusModule":{"statusVerifiedDate":"2021-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2015-11-18","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2017-12-15","type":"ACTUAL"},"completionDateStruct":{"date":"2017-12-22","type":"ACTUAL"},"studyFirstSubmitDate":"2015-11-16","studyFirstSubmitQcDate":"2015-11-16","studyFirstPostDateStruct":{"date":"2015-11-18","type":"ESTIMATED"},"resultsFirstSubmitDate":"2018-12-07","resultsFirstSubmitQcDate":"2019-07-17","resultsFirstPostDateStruct":{"date":"2019-07-29","type":"ACTUAL"},"lastUpdateSubmitDate":"2021-03-10","lastUpdatePostDateStruct":{"date":"2021-04-09","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This trial is conducted in Asia. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide, insulin degludec and liraglutide in Japanese subjects with type 2 diabetes mellitus."},"conditionsModule":{"conditions":["Diabetes","Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":819,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Insulin degludec/liraglutide OD","type":"EXPERIMENTAL","interventionNames":["Drug: insulin degludec/liraglutide"]},{"label":"Insulin degludec OD","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: insulin degludec"]},{"label":"Liraglutide OD","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: liraglutide"]}],"interventions":[{"type":"DRUG","name":"insulin degludec/liraglutide","description":"Injected s.c. / subcutaneously (under the skin) once daily (OD) , in combination with pre-trial OAD (oral antidiabetic drug)kept in unchanged dose.","armGroupLabels":["Insulin degludec/liraglutide OD"]},{"type":"DRUG","name":"insulin degludec","description":"Injected s.c. / subcutaneously (under the skin) once daily (OD) , in combination with pre-trial OAD (oral antidiabetic drug)kept in unchanged dose.","armGroupLabels":["Insulin degludec OD"]},{"type":"DRUG","name":"liraglutide","description":"Injected s.c. / subcutaneously (under the skin) once daily (OD) , in combination with pre-trial OAD (oral antidiabetic drug)kept in unchanged dose.","armGroupLabels":["Liraglutide OD"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Non-inferiority of IDegLira vs IDeg and Superiority of IDegLira vs Lira","description":"Change from baseline (week 0) in HbA1c after 52 weeks of treatment was measured. Statistical analyses were performed to test the hypotheses: non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Liraglutide (Lira).","timeFrame":"Week 0, Week 52"}],"secondaryOutcomes":[{"measure":"Change From Baseline in Body Weight (kg)","description":"Change from baseline (week 0) in body weight after 52 weeks of treatment.","timeFrame":"Week 0, Week 52"},{"measure":"Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes","description":"Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.\n\nSevere or BG confirmed hypoglycaemic episodes were defined as episodes that were 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 or without symptoms consistent with hypoglycaemia.\n\nSevere hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.","timeFrame":"Weeks 0-52"},{"measure":"Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Superiority of IDegLira vs IDeg","description":"Change from baseline (week 0) in HbA1c after 52 weeks of treatment was measured. Statistical analysis was performed to test the hypothesis: superiority of IDegLira vs. IDeg.","timeFrame":"Week 0, Week 52"},{"measure":"Change From Baseline in Fasting Plasma Glucose (FPG)","description":"Change from baseline (week 0) in FPG after 52 weeks","timeFrame":"Week 0, Week 52"},{"measure":"Insulin Dose","description":"Actual daily total insulin dose after 52 weeks of treatment.","timeFrame":"After 52 weeks of treatment"},{"measure":"Responder (Yes/no): HbA1c Less Than 7.0%","description":"Number of subjects with HbA1c less than 7.0% after 52 weeks of treatment.","timeFrame":"After 52 weeks of treatment"},{"measure":"Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to Zero","description":"Number of subjects with HbA1c less than 7.0% and without weight gain after 52 weeks of treatment.","timeFrame":"After 52 weeks of treatment"},{"measure":"Responder (Yes/no): HbA1c Less Than 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.","description":"Number of subjects with HbA1c less than 7.0% after 52 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.\n\nTreatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.\n\nSevere or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were 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.","timeFrame":"After 52 weeks of treatment"},{"measure":"Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to Zero and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment","description":"Number of subjects with HbA1c less than 7.0% and without weight gain, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.\n\nTreatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.\n\nSevere or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were 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.","timeFrame":"After 52 weeks of treatment"},{"measure":"Responder (Yes/no): HbA1c Less Than 6.5%","description":"Number of subjects with HbA1c less than 6.5% after 52 weeks of treatment.","timeFrame":"After 52 weeks of treatment"},{"measure":"Responder (Yes/no): HbA1c Less Than 6.5% and Change in Body Weight From Baseline Below or Equal to Zero","description":"Number of subjects with HbA1c less than 6.5% and without weight gain after 52 weeks of treatment.","timeFrame":"After 52 weeks of treatment"},{"measure":"Responder (Yes/no): HbA1c Less Than 6.5% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.","description":"Number of subjects with HbA1c less than 6.5% after 52 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.\n\nTreatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.\n\nSevere or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were 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.","timeFrame":"After 52 weeks of treatment"},{"measure":"Responder (Yes/no): HbA1c Less Than 6.5% and Change in Body Weight From Baseline Below or Equal to Zero and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment","description":"Number of subjects with HbA1c less than 6.5% with no weight gain, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.\n\nTreatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.\n\nSevere or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were 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.","timeFrame":"After 52 weeks of treatment"},{"measure":"Change in Waist Circumference","description":"Change from baseline (week 0) in waist circumference after 52 weeks of treatment.","timeFrame":"Week 0, Week 52"},{"measure":"Change in Blood Pressure (Systolic and Diastolic)","description":"Change from baseline in blood pressure (systolic and diastolic) after 52 weeks of treatment.","timeFrame":"Week 0, Week 52"},{"measure":"Self-Measured Blood Glucose (SMBG) 9-point Profile: 9-point Profile (Individual Points in the Profile)","description":"Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day.","timeFrame":"After 52 weeks of the treatment"},{"measure":"Change in SMBG 9-point Profile - Mean of the 9-point Profile","description":"Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day. Mean of the 9-point profile was defined as the area under the profile (calculated using the trapezoidal method) divided by the measurement time.","timeFrame":"Week 0, week 52"},{"measure":"Change in SMBG 9-point Profile - Mean of Postprandial Increments (From Before Meal to 90 Min After for Breakfast, Lunch and Dinner)","description":"Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day. The mean increment over all meals was derived as the mean of all available meal increments.","timeFrame":"Week 0, week 52"},{"measure":"Total Cholesterol as a Ratio to Baseline at 52 Weeks","description":"Total cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values.","timeFrame":"After 52 weeks of treatment"},{"measure":"Low Density Lipoprotein (LDL) Cholesterol as a Ratio to Baseline at 52 Weeks","description":"Low density lipoprotein (LDL) cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values.","timeFrame":"After 52 weeks of treatment"},{"measure":"High Density Lipoprotein (HDL) Cholesterol as a Ratio to Baseline at 52 Weeks","description":"High density lipoprotein (HDL) cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values.","timeFrame":"After 52 weeks of treatment"},{"measure":"Very Low Density Lipoprotein (VLDL) Cholesterol as a Ratio to Baseline at 52 Weeks","description":"Very low density lipoprotein (VLDL) cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values.","timeFrame":"After 52 weeks of treatment"},{"measure":"Triglycerides as a Ratio to Baseline at 52 Weeks","description":"Triglycerides after 52 weeks of treatment was represented as ratio to baseline (week 0) values.","timeFrame":"After 52 weeks of treatment"},{"measure":"Free Fatty Acids as a Ratio to Baseline at 52 Weeks","description":"Free fatty acids after 52 weeks of treatment was represented as ratio to baseline (week 0) values.","timeFrame":"After 52 weeks of treatment"},{"measure":"Fasting C-peptide as a Ratio to Baseline at 52 Weeks","description":"Fasting C-peptide after 52 weeks of treatment was represented as ratio to baseline (week 0) values.","timeFrame":"After 52 weeks of treatment"},{"measure":"Fasting Human Insulin as a Ratio to Baseline at 52 Weeks","description":"Fasting human insulin after 52 weeks of treatment was represented as ratio to baseline (week 0) values.","timeFrame":"After 52 weeks of treatment"},{"measure":"Fasting Glucagon as a Ratio to Baseline at 52 Weeks","description":"Fasting glucagon after 52 weeks of treatment was represented as ratio to baseline (week 0) values.","timeFrame":"After 52 weeks of treatment"},{"measure":"Proinsulin as a Ratio to Baseline at 52 Weeks","description":"Proinsulin after 52 weeks of treatment was represented as ratio to baseline (week 0) values.","timeFrame":"After 52 weeks of treatment"},{"measure":"Number of Treatment Emergent Adverse Events (TEAEs)","description":"Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.","timeFrame":"0-52 weeks"},{"measure":"Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes","description":"Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.\n\nSevere or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were 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.\n\nSevere hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.","timeFrame":"0-52 weeks"},{"measure":"Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes","description":"Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. Nocturnal period: The period between 00:01 and 05:59 a.m. (both inclusive).\n\nSevere or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were 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.\n\nSevere hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.","timeFrame":"0-52 weeks"},{"measure":"Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA) Definition","description":"Results represent total number of treatment emergent hypoglycaemic episodes that fall under ADA's definition of hypoglycaemia. ADA's definition of hypoglycaemia includes following categories:\n\n1. Severe hypoglycaemia\n2. Documented symptomatic hypoglycaemia\n3. Asymptomatic hypoglycaemia\n4. Probable symptomatic hypoglycaemia\n5. Pseudo-hypoglycaemia. Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.","timeFrame":"0-52 weeks"},{"measure":"Anti-drug Antibodies: Anti-insulin Degludec Antibodies","description":"Insulin degludec (IDeg)-specific antibodies were measured at week 52, as %B/T (percentage of bound \\& precipitated radioactive drug/total added drug to the sample). A sample is measured in 2 different series. In series 1, the radioactive IDeg (tracer) and surplus unlabeled IDeg are added to the sample. In series 2, the tracer and surplus unlabeled human insulin are added to the sample. Series 1 represents unspecific background binding. Series 2 represents IDeg specific antibodies including unspecific background binding. The reported %B/T is calculated by subtracting the background %B/T in series 1 from the %B/T result in series 2. If the background result has higher values than the %B/T in series 2, the resulting value is negative %B/T. Here, a negative %B/T value means that the test samples do not have IDeg-specific antibodies. The reason for getting a negative value for %B/T is due to variation in the analytical background. Thus, the results presented are not a change from baseline.","timeFrame":"at week 52"},{"measure":"Anti-drug Antibodies: Number of Participants Positive or Negative for Anti-liraglutide Antibodies","description":"Anti-liraglutide antibodies were measured at week 52. Number of participants positive or negative for anti-liraglutide antibodies at week 52 were reported.","timeFrame":"at week 52"},{"measure":"Change in Clinical Evaluation: Fundoscopy or Fundus Photography","description":"The result of the fundus photography/dilated fundoscopy was interpreted by the investigator into following categories: Normal; Abnormal (Abn), Not Clinically significant (NCS); Abnormal, Clinically significant (CS). Reported results are number of subjects with 'normal'; 'Abn, NCS' and 'Abn, CS' fundoscopy/fundus photography results at screening (week -2 to week 0) and week 52.","timeFrame":"at screening (week -2 to week 0), at week 52"},{"measure":"Change in Clinical Evaluation: Electrocardiogram (ECG)","description":"The result of the ECG was interpreted by the investigator into following categories: Normal; Abnormal (Abn), Not Clinically significant (NCS); Abnormal, Clinically significant (CS). Reported results are number of subjects with 'normal'; 'Abn, NCS' and 'Abn, CS' ECG results at screening (week -2 to week 0) and week 52.","timeFrame":"at screening (week -2 to week 0), at week 52"},{"measure":"Change in Clinical Evaluation: Pulse","description":"Change in pulse after 52 weeks of treatment.","timeFrame":"Week 0, week 52"},{"measure":"Serum Concentrations of Insulin Degludec","description":"Samples from the IDegLira and IDeg arms were analysed for serum concentrations of insulin degludec using validated ELISA assays.","timeFrame":"Weeks 2, 8, 16, 26, 44, 52"},{"measure":"Plasma Concentrations of Liraglutide","description":"Samples from the IDegLira and liraglutide arms were assayed for plasma concentrations of liraglutide using validated ELISA assays.","timeFrame":"Weeks 2, 8, 16, 26, 44, 52"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female Japanese subjects, age at least 20 years at the time of signing informed consent\n* Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening\n* HbA1c (glycosylated haemoglobin) 7.0-11.0 % (both inclusive) by central laboratory analysis, with the aim of a median of 8.3%. When approximately 50% of the randomised subjects have a HbA1c above 8.3%, the remaining subjects randomised must have a HbA1c below or equal to 8.3%; or when approximately 50% of the randomised subjects have a HbA1c below or equal to 8.3%, the remaining subjects randomised must have a HbA1c above 8.3%\n* Body-mass index (BMI) above or equal to 20 kg/m\\^2\n* Subjects on stable therapy with one OAD (defined as unchanged medication and unchanged dose) for at least 60 days (metformin, a-GI, TZD, SU, SGLT2i or glinide) prior to screening according to approved Japanese labelling\n\nExclusion Criteria:\n\n* Previous treatment with insulin (except for short-term treatment in connection with intercurrent illness including gestational diabetes)\n* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 60 days before screening\n* Anticipated initiation or change in concomitant medications in excess of 14 days known to affect weight or glucose metabolism\n* Impaired liver function, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) equal to or above 2.5 times upper limit of normal\n* Renal impairment estimated Glomerular Filtration Rate (eGFR) below 60mL/min/1.73m\\^2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)\n* Screening calcitonin equal to or above 50 ng/L\n* History of pancreatitis (acute or chronic)\n* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)\n* Subjects presently classified as being in New York Heart Association (NYHA) Class IV","healthyVolunteers":false,"sex":"ALL","minimumAge":"20 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"Novo Nordisk Investigational Site","city":"Adachi-ku, Tokyo","zip":"123-0845","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}},{"facility":"Novo Nordisk Investigational Site","city":"Akita-shi, Akita","zip":"010-8543","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Annaka-shi, Gunma","zip":"379-0116","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Asahikawa-shi, Hokkaido","zip":"070-0002","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Chiba-shi, Chiba","zip":"260-0804","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Chitose, Hokkaido","zip":"066-0032","country":"Japan","geoPoint":{"lat":42.81944,"lon":141.65222}},{"facility":"Novo Nordisk Investigational Site","city":"Chuo-ku, Tokyo","zip":"103-0002","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Chuo-ku,Tokyo","zip":"103-0025","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Chūōku","zip":"104 0061","country":"Japan","geoPoint":{"lat":33.63867,"lon":130.67068}},{"facility":"Novo Nordisk Investigational Site","city":"Edogawa-ku, Tokyo","zip":"134-0084","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}},{"facility":"Novo Nordisk Investigational Site","city":"Fujisawa-shi, Kanagawa","zip":"251-0041","country":"Japan","geoPoint":{"lat":37.58333,"lon":139.91667}},{"facility":"Novo Nordisk Investigational Site","city":"Fukuoka-shi, Fukuoka","zip":"819-0168","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Fukushima","zip":"963-8851","country":"Japan","geoPoint":{"lat":37.75,"lon":140.46667}},{"facility":"Novo Nordisk Investigational Site","city":"Gunma","zip":"373-0036","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Hachioji-shi, Tokyo","zip":"192-0917","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}},{"facility":"Novo Nordisk Investigational Site","city":"Hokkaido","zip":"060-0062","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Hokkaido","zip":"078-8236","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Ibaraki","zip":"311-0113","country":"Japan","geoPoint":{"lat":34.81641,"lon":135.56828}},{"facility":"Novo Nordisk Investigational Site","city":"Ichihara-shi, Chiba","zip":"290-0003","country":"Japan","geoPoint":{"lat":35.6,"lon":140.11667}},{"facility":"Novo Nordisk Investigational Site","city":"Iruma-shi, Saitama","zip":"358-0011","country":"Japan","geoPoint":{"lat":35.90807,"lon":139.65657}},{"facility":"Novo Nordisk Investigational Site","city":"Itabashi-ku, Tokyo","zip":"173-0004","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}},{"facility":"Novo Nordisk Investigational Site","city":"Itabashi-ku, Tokyo","zip":"175-0093","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}},{"facility":"Novo Nordisk Investigational Site","city":"Izumisano","zip":"598 0048","country":"Japan","geoPoint":{"lat":34.41667,"lon":135.31667}},{"facility":"Novo Nordisk Investigational Site","city":"Izumisano-shi,Osaka","zip":"598-8577","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Kagoshima-shi, Kagoshima","zip":"890-0061","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Kamakura-shi","zip":"247 0056","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Kanagawa","zip":"235-0045","country":"Japan","geoPoint":{"lat":37.58333,"lon":139.91667}},{"facility":"Novo Nordisk Investigational Site","city":"Kanra-gun, Gunma","zip":"370-2214","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Kashiwara-shi, Osaka","zip":"582-0005","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"Novo Nordisk Investigational Site","city":"Kawagoe-shi, Saitama","zip":"350-0851","country":"Japan","geoPoint":{"lat":35.90807,"lon":139.65657}},{"facility":"Novo Nordisk Investigational Site","city":"Kawaguchi-shi, Saitama","zip":"332-0012","country":"Japan","geoPoint":{"lat":35.90807,"lon":139.65657}},{"facility":"Novo Nordisk Investigational Site","city":"Kawasaki-shi,Kanagawa","zip":"215-0026","country":"Japan","geoPoint":{"lat":37.58333,"lon":139.91667}},{"facility":"Novo Nordisk Investigational Site","city":"Kisarazu-shi, Chiba","zip":"292-0038","country":"Japan","geoPoint":{"lat":35.6,"lon":140.11667}},{"facility":"Novo Nordisk Investigational Site","city":"Kobe-shi, Hyogo","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Kuki-shi, Saitama","zip":"346-8530","country":"Japan","geoPoint":{"lat":35.90807,"lon":139.65657}},{"facility":"Novo Nordisk Investigational Site","city":"Kumamoto","zip":"862-0976","country":"Japan","geoPoint":{"lat":32.80589,"lon":130.69181}},{"facility":"Novo Nordisk Investigational Site","city":"Kumamoto-shi, Kumamoto","zip":"860-0811","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Kumamoto-shi, Kumamoto","zip":"861-8039","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Kushiro-shi, Hokkaido","zip":"085-0032","country":"Japan","geoPoint":{"lat":42.975,"lon":144.37472}},{"facility":"Novo Nordisk Investigational Site","city":"Kyoto-shi, Kyoto","zip":"606-8507","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Minato-ku, Tokyo","zip":"108-0075","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Mito-shi, Ibaraki","zip":"310-0826","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Mito-shi, Ibaraki","zip":"311-4153","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Miura-shi, Kanagawa","zip":"238-0101","country":"Japan","geoPoint":{"lat":37.58333,"lon":139.91667}},{"facility":"Novo Nordisk Investigational Site","city":"Miyazaki","zip":"880-0034","country":"Japan","geoPoint":{"lat":31.91667,"lon":131.41667}},{"facility":"Novo Nordisk Investigational Site","city":"Nagoya-shi, Aichi","zip":"455-8530","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Nagoya-shi, Aichi","zip":"456-0058","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Nishinomiya-shi, Hygo","zip":"662 0971","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Obihiro-shi, Hokkaido","zip":"080 0016","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Obihiro-shi, Hokkaido","zip":"080 0848","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Okawa-shi, Fukuoka","zip":"831-0016","country":"Japan","geoPoint":{"lat":33.6,"lon":130.41667}},{"facility":"Novo Nordisk Investigational Site","city":"Onga-gun, Fukuoka","zip":"811-4342","country":"Japan","geoPoint":{"lat":33.6,"lon":130.41667}},{"facility":"Novo Nordisk Investigational Site","city":"Osaka","zip":"569-1045","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"Novo Nordisk Investigational Site","city":"Osaka-shi, Osaka","zip":"530-0013","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Osaka-shi, Osaka","zip":"533-0024","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Osaka-shi, Osaka","zip":"536-0001","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Ota-ku, Tokyo","zip":"1430015","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Ōita","zip":"870 0039","country":"Japan","geoPoint":{"lat":33.23333,"lon":131.6}},{"facility":"Novo Nordisk Investigational Site","city":"Saijo-shi, Ehime","zip":"793-0027","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Sapporo-shi, Hokkaido","zip":"004-0004","country":"Japan","geoPoint":{"lat":43.06667,"lon":141.35}},{"facility":"Novo Nordisk Investigational Site","city":"Sapporo-shi, Hokkaido","zip":"060-0001","country":"Japan","geoPoint":{"lat":43.06667,"lon":141.35}},{"facility":"Novo Nordisk 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Kanagawa","zip":"242-0004","country":"Japan","geoPoint":{"lat":37.58333,"lon":139.91667}}]},"referencesModule":{"references":[{"pmid":"31407845","type":"RESULT","citation":"Kaku K, Araki E, Tanizawa Y, Ross Agner B, Nishida T, Ranthe M, Inagaki N. Superior efficacy with a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with insulin degludec and liraglutide in insulin-naive Japanese patients with type 2 diabetes in a phase 3, open-label, randomized trial. Diabetes Obes Metab. 2019 Dec;21(12):2674-2683. doi: 10.1111/dom.13856. Epub 2019 Aug 28."},{"pmid":"33595901","type":"RESULT","citation":"Komatsu M, Watada H, Kaneko S, Ross Agner BF, Nishida T, Kaku K. Efficacy and safety of the fixed-ratio combination of insulin degludec and liraglutide by baseline glycated hemoglobin, body mass index and age in Japanese individuals with type 2 diabetes: A subgroup analysis of two phase III trials. J Diabetes Investig. 2021 Sep;12(9):1610-1618. doi: 10.1111/jdi.13525. Epub 2021 Mar 24."}],"seeAlsoLinks":[{"label":"Clinical Trials at Novo Nordisk","url":"http://novonordisk-trials.com"}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"The trial was conducted at 71 sites in Japan. 71 sites screened and randomised subjects.","groups":[{"id":"FG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"FG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"FG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"275"},{"groupId":"FG001","numSubjects":"271"},{"groupId":"FG002","numSubjects":"273"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"254"},{"groupId":"FG001","numSubjects":"248"},{"groupId":"FG002","numSubjects":"263"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"23"},{"groupId":"FG002","numSubjects":"10"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"6"}]},{"type":"Unclassified","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"BG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"BG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"275"},{"groupId":"BG001","value":"271"},{"groupId":"BG002","value":"273"},{"groupId":"BG003","value":"819"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"56.9","spread":"10.2"},{"groupId":"BG001","value":"57.8","spread":"9.9"},{"groupId":"BG002","value":"56.8","spread":"10.1"},{"groupId":"BG003","value":"57.2","spread":"10.1"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"81"},{"groupId":"BG001","value":"76"},{"groupId":"BG002","value":"81"},{"groupId":"BG003","value":"238"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"194"},{"groupId":"BG001","value":"195"},{"groupId":"BG002","value":"192"},{"groupId":"BG003","value":"581"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"275"},{"groupId":"BG001","value":"271"},{"groupId":"BG002","value":"273"},{"groupId":"BG003","value":"819"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"275"},{"groupId":"BG001","value":"271"},{"groupId":"BG002","value":"273"},{"groupId":"BG003","value":"819"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Glycosylated Haemoglobin (HbA1c)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Percentage of HbA1c","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.52","spread":"1.12"},{"groupId":"BG001","value":"8.53","spread":"1.05"},{"groupId":"BG002","value":"8.32","spread":"0.99"},{"groupId":"BG003","value":"8.45","spread":"1.06"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Non-inferiority of IDegLira vs IDeg and Superiority of IDegLira vs Lira","description":"Change from baseline (week 0) in HbA1c after 52 weeks of treatment was measured. Statistical analyses were performed to test the hypotheses: non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Liraglutide (Lira).","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". Missing data were imputed using last observation carried forward (LOCF) method.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.42","spread":"1.04"},{"groupId":"OG001","value":"-1.80","spread":"1.02"},{"groupId":"OG002","value":"-1.80","spread":"0.92"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The change from baseline in response after 52 weeks are analysed using an ANCOVA model with treatment and pre-trial OAD as fixed factors and baseline HbA1c value as covariate.","nonInferiorityType":"NON_INFERIORITY","nonInferiorityComment":"Non-inferiority of IDegLira vs. IDeg was confirmed if the 95% confidence interval for the mean treatment difference lies entirely below 0.3%.","pValue":"<0.0001","pValueComment":"p-value for non-inferiority of IDegLira vs IDeg is presented","statisticalMethod":"ANCOVA","paramType":"Treatment contrast","paramValue":"-0.63","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.75","ciUpperLimit":"-0.52"},{"groupIds":["OG000","OG002"],"groupDescription":"The change from baseline in response after 52 weeks are analysed using an ANCOVA model with treatment and pre-trial OAD as fixed factors and baseline HbA1c value as covariate.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Superiority of IDegLira vs. Lira was confirmed if the 95% confidence interval for the mean treatment difference for change from baseline in HbA1c lies entirely below 0.0%.","pValue":"<0.0001","pValueComment":"p-value for superiority of IDegLira vs Lira is presented","statisticalMethod":"ANCOVA","paramType":"Treatment contrast","paramValue":"-0.48","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.60","ciUpperLimit":"-0.37"}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight (kg)","description":"Change from baseline (week 0) in body weight after 52 weeks of treatment.","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". Missing data were imputed using last observation carried forward (LOCF) method.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kg","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.9","spread":"3.2"},{"groupId":"OG001","value":"4.1","spread":"4.3"},{"groupId":"OG002","value":"-1.0","spread":"3.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The change from baseline in response after 52 weeks were analysed using an ANCOVA method with treatment and pre-trial OAD treatment as fixed factors and baseline body weight as covariate.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"A hierarchical testing procedure is used to control the overall type I error on a two sided 5% level. If and only if non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Lira are confirmed in the primary analysis (change in HbA1c), the three secondary confirmatory tests are performed for superiority of IDegLira versus IDeg with a fixed sequence (1. change in body weight, 2. number of treatment emergent severe or BG confirmed hypoglycaemic episodes and 3. change in HbA1c).","pValue":"0.0001","pValueComment":"p-value for superiority of IDegLira vs IDeg is presented","statisticalMethod":"ANCOVA","paramType":"Treatment contrast","paramValue":"-1.19","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.80","ciUpperLimit":"-0.59"}]},{"type":"SECONDARY","title":"Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes","description":"Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.\n\nSevere or BG confirmed hypoglycaemic episodes were defined as episodes that were 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 or without symptoms consistent with hypoglycaemia.\n\nSevere hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.","populationDescription":"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation \"as treated\".","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"Weeks 0-52","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"467"},{"groupId":"OG001","value":"869"},{"groupId":"OG002","value":"13"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The number of events is analysed using a negative binomial regression model (log link) with the logarithm of the treatment emergent exposure time (100 years) as offset. The model includes treatment and pre-trial OAD treatment as fixed factors.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"A hierarchical testing procedure is used to control the overall type I error on a two sided 5% level. If and only if non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Lira are confirmed in the primary analysis (change in HbA1c), the three secondary confirmatory tests are performed for superiority of IDegLira versus IDeg with a fixed sequence (1. change in body weight, 2. number of treatment emergent severe or BG confirmed hypoglycaemic episodes and 3. change in HbA1c).","pValue":"<0.0001","pValueComment":"p-value for superiority of IDegLira vs IDeg is presented","statisticalMethod":"Negative binomial regression","paramType":"Treatment contrast","paramValue":"0.48","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.35","ciUpperLimit":"0.68"}]},{"type":"SECONDARY","title":"Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Superiority of IDegLira vs IDeg","description":"Change from baseline (week 0) in HbA1c after 52 weeks of treatment was measured. Statistical analysis was performed to test the hypothesis: superiority of IDegLira vs. IDeg.","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". Missing data were imputed using last observation carried forward (LOCF) method.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.42","spread":"1.04"},{"groupId":"OG001","value":"-1.80","spread":"1.02"},{"groupId":"OG002","value":"-1.80","spread":"0.92"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The change from baseline in response after 52 weeks are analysed using an ANCOVA model with treatment, pre-trial OAD as fixed factors and corresponding baseline HbA1c value as covariate.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"A hierarchical testing procedure is used to control the overall type I error on a two sided 5% level. If and only if non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Lira are confirmed in the primary analysis (change in HbA1c), the three secondary confirmatory tests are performed for superiority of IDegLira versus IDeg with a fixed sequence (1. change in body weight, 2. number of treatment emergent severe or BG confirmed hypoglycaemic episodes and 3. change in HbA1c).","pValue":"<0.0001","pValueComment":"p-value for superiority of IDegLira vs IDeg is presented","statisticalMethod":"ANCOVA","paramType":"Treatment contrast","paramValue":"-0.63","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.75","ciUpperLimit":"-0.52"}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Plasma Glucose (FPG)","description":"Change from baseline (week 0) in FPG after 52 weeks","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"272"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.08","spread":"2.47"},{"groupId":"OG001","value":"-3.97","spread":"2.56"},{"groupId":"OG002","value":"-2.62","spread":"1.95"}]}]}]},{"type":"SECONDARY","title":"Insulin Dose","description":"Actual daily total insulin dose after 52 weeks of treatment.","populationDescription":"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation \"as treated\". Missing data were imputed using LOCF method. This endpoint evaluation is only applicable for subjects in IDegLira and IDeg arm.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Insulin Units/Day","timeFrame":"After 52 weeks of treatment","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"27.7","spread":"14.8"},{"groupId":"OG001","value":"34.8","spread":"26.0"}]}]}]},{"type":"SECONDARY","title":"Responder (Yes/no): HbA1c Less Than 7.0%","description":"Number of subjects with HbA1c less than 7.0% after 52 weeks of treatment.","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". Missing data were imputed using last observation carried forward (LOCF) method.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"After 52 weeks of treatment","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"245"},{"groupId":"OG001","value":"189"},{"groupId":"OG002","value":"208"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"82"},{"groupId":"OG002","value":"65"}]}]}]},{"type":"SECONDARY","title":"Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to Zero","description":"Number of subjects with HbA1c less than 7.0% and without weight gain after 52 weeks of treatment.","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". Missing data were imputed using last observation carried forward (LOCF) method.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"After 52 weeks of treatment","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"22"},{"groupId":"OG002","value":"142"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"249"},{"groupId":"OG002","value":"131"}]}]}]},{"type":"SECONDARY","title":"Responder (Yes/no): HbA1c Less Than 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.","description":"Number of subjects with HbA1c less than 7.0% after 52 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.\n\nTreatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.\n\nSevere or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were 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.","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"After 52 weeks of treatment","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"270"},{"groupId":"OG001","value":"265"},{"groupId":"OG002","value":"271"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"227"},{"groupId":"OG001","value":"169"},{"groupId":"OG002","value":"206"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"96"},{"groupId":"OG002","value":"65"}]}]}]},{"type":"SECONDARY","title":"Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to Zero and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment","description":"Number of subjects with HbA1c less than 7.0% and without weight gain, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.\n\nTreatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.\n\nSevere or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were 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.","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"After 52 weeks of treatment","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"270"},{"groupId":"OG001","value":"265"},{"groupId":"OG002","value":"271"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"22"},{"groupId":"OG002","value":"141"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"243"},{"groupId":"OG002","value":"130"}]}]}]},{"type":"SECONDARY","title":"Responder (Yes/no): HbA1c Less Than 6.5%","description":"Number of subjects with HbA1c less than 6.5% after 52 weeks of treatment.","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". Missing data were imputed using last observation carried forward (LOCF) method.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"After 52 weeks of treatment","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"213"},{"groupId":"OG001","value":"134"},{"groupId":"OG002","value":"171"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"137"},{"groupId":"OG002","value":"102"}]}]}]},{"type":"SECONDARY","title":"Responder (Yes/no): HbA1c Less Than 6.5% and Change in Body Weight From Baseline Below or Equal to Zero","description":"Number of subjects with HbA1c less than 6.5% and without weight gain after 52 weeks of treatment.","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". Missing data were imputed using last observation carried forward (LOCF) method.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"After 52 weeks of treatment","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"17"},{"groupId":"OG002","value":"126"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"234"},{"groupId":"OG001","value":"254"},{"groupId":"OG002","value":"147"}]}]}]},{"type":"SECONDARY","title":"Responder (Yes/no): HbA1c Less Than 6.5% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.","description":"Number of subjects with HbA1c less than 6.5% after 52 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.\n\nTreatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.\n\nSevere or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were 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.","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"After 52 weeks of treatment","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"270"},{"groupId":"OG001","value":"265"},{"groupId":"OG002","value":"271"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"198"},{"groupId":"OG001","value":"123"},{"groupId":"OG002","value":"170"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"72"},{"groupId":"OG001","value":"142"},{"groupId":"OG002","value":"101"}]}]}]},{"type":"SECONDARY","title":"Responder (Yes/no): HbA1c Less Than 6.5% and Change in Body Weight From Baseline Below or Equal to Zero and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment","description":"Number of subjects with HbA1c less than 6.5% with no weight gain, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.\n\nTreatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.\n\nSevere or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were 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.","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"After 52 weeks of treatment","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"270"},{"groupId":"OG001","value":"265"},{"groupId":"OG002","value":"271"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"17"},{"groupId":"OG002","value":"125"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"235"},{"groupId":"OG001","value":"248"},{"groupId":"OG002","value":"146"}]}]}]},{"type":"SECONDARY","title":"Change in Waist Circumference","description":"Change from baseline (week 0) in waist circumference after 52 weeks of treatment.","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". Missing data were imputed using last observation carried forward (LOCF) method.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Cm","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.5","spread":"4.5"},{"groupId":"OG001","value":"3.4","spread":"5.2"},{"groupId":"OG002","value":"-1.1","spread":"4.4"}]}]}]},{"type":"SECONDARY","title":"Change in Blood Pressure (Systolic and Diastolic)","description":"Change from baseline in blood pressure (systolic and diastolic) after 52 weeks of treatment.","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". Missing data were imputed using last observation carried forward (LOCF) method.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmHg","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"classes":[{"title":"Systolic blood pressure","categories":[{"measurements":[{"groupId":"OG000","value":"1.7","spread":"12.0"},{"groupId":"OG001","value":"3.4","spread":"14.3"},{"groupId":"OG002","value":"-1.8","spread":"13.0"}]}]},{"title":"Diastolic blood pressure","categories":[{"measurements":[{"groupId":"OG000","value":"0.5","spread":"7.9"},{"groupId":"OG001","value":"0.6","spread":"9.3"},{"groupId":"OG002","value":"-0.4","spread":"8.3"}]}]}]},{"type":"SECONDARY","title":"Self-Measured Blood Glucose (SMBG) 9-point Profile: 9-point Profile (Individual Points in the Profile)","description":"Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day.","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"After 52 weeks of the treatment","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"classes":[{"title":"Before breakfast","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.90","spread":"1.45"},{"groupId":"OG001","value":"5.93","spread":"1.64"},{"groupId":"OG002","value":"7.35","spread":"1.70"}]}]},{"title":"90 minutes after start of breakfast","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"274"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"272"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"9.57","spread":"2.83"},{"groupId":"OG001","value":"10.43","spread":"3.16"},{"groupId":"OG002","value":"10.59","spread":"3.25"}]}]},{"title":"Before lunch","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"269"},{"groupId":"OG002","value":"270"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6.01","spread":"1.90"},{"groupId":"OG001","value":"6.72","spread":"2.59"},{"groupId":"OG002","value":"6.87","spread":"2.07"}]}]},{"title":"90 minutes after start of lunch","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"274"},{"groupId":"OG001","value":"270"},{"groupId":"OG002","value":"270"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"9.85","spread":"3.16"},{"groupId":"OG001","value":"11.12","spread":"3.04"},{"groupId":"OG002","value":"10.59","spread":"3.38"}]}]},{"title":"Before dinner","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"274"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6.47","spread":"2.44"},{"groupId":"OG001","value":"6.90","spread":"2.57"},{"groupId":"OG002","value":"7.03","spread":"2.04"}]}]},{"title":"90 minutes after start of dinner","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"274"},{"groupId":"OG001","value":"270"},{"groupId":"OG002","value":"270"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"9.67","spread":"3.01"},{"groupId":"OG001","value":"10.89","spread":"3.25"},{"groupId":"OG002","value":"10.14","spread":"3.03"}]}]},{"title":"Bedtime","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"271"},{"groupId":"OG001","value":"269"},{"groupId":"OG002","value":"268"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"8.27","spread":"2.79"},{"groupId":"OG001","value":"9.49","spread":"3.28"},{"groupId":"OG002","value":"8.73","spread":"2.58"}]}]},{"title":"At 4:00 a.m.","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"272"},{"groupId":"OG001","value":"268"},{"groupId":"OG002","value":"270"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6.12","spread":"1.70"},{"groupId":"OG001","value":"6.41","spread":"2.18"},{"groupId":"OG002","value":"7.27","spread":"1.79"}]}]},{"title":"Before breakfast the following day","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.77","spread":"1.56"},{"groupId":"OG001","value":"5.71","spread":"1.68"},{"groupId":"OG002","value":"7.13","spread":"1.68"}]}]}]},{"type":"SECONDARY","title":"Change in SMBG 9-point Profile - Mean of the 9-point Profile","description":"Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day. Mean of the 9-point profile was defined as the area under the profile (calculated using the trapezoidal method) divided by the measurement time.","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"269"},{"groupId":"OG002","value":"272"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.60","spread":"2.65"},{"groupId":"OG001","value":"-3.84","spread":"2.63"},{"groupId":"OG002","value":"-3.46","spread":"2.37"}]}]}]},{"type":"SECONDARY","title":"Change in SMBG 9-point Profile - Mean of Postprandial Increments (From Before Meal to 90 Min After for Breakfast, Lunch and Dinner)","description":"Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day. The mean increment over all meals was derived as the mean of all available meal increments.","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"269"},{"groupId":"OG002","value":"272"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.74","spread":"2.51"},{"groupId":"OG001","value":"-0.27","spread":"2.39"},{"groupId":"OG002","value":"-1.01","spread":"2.38"}]}]}]},{"type":"SECONDARY","title":"Total Cholesterol as a Ratio to Baseline at 52 Weeks","description":"Total cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values.","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". Missing data were imputed using last observation carried forward (LOCF) method.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio","timeFrame":"After 52 weeks of treatment","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.92","spread":"13.9"},{"groupId":"OG001","value":"0.97","spread":"11.9"},{"groupId":"OG002","value":"0.94","spread":"13.0"}]}]}]},{"type":"SECONDARY","title":"Low Density Lipoprotein (LDL) Cholesterol as a Ratio to Baseline at 52 Weeks","description":"Low density lipoprotein (LDL) cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values.","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". Missing data were imputed using last observation carried forward (LOCF) method.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio","timeFrame":"After 52 weeks of treatment","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.91","spread":"23.4"},{"groupId":"OG001","value":"0.99","spread":"18.2"},{"groupId":"OG002","value":"0.93","spread":"24.2"}]}]}]},{"type":"SECONDARY","title":"High Density Lipoprotein (HDL) Cholesterol as a Ratio to Baseline at 52 Weeks","description":"High density lipoprotein (HDL) cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values.","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". Missing data were imputed using last observation carried forward (LOCF) method.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio","timeFrame":"After 52 weeks of treatment","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.94","spread":"16.4"},{"groupId":"OG001","value":"0.94","spread":"14.6"},{"groupId":"OG002","value":"0.99","spread":"14.5"}]}]}]},{"type":"SECONDARY","title":"Very Low Density Lipoprotein (VLDL) Cholesterol as a Ratio to Baseline at 52 Weeks","description":"Very low density lipoprotein (VLDL) cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values.","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". Missing data were imputed using last observation carried forward (LOCF) method.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio","timeFrame":"After 52 weeks of treatment","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.92","spread":"44.3"},{"groupId":"OG001","value":"0.97","spread":"42.1"},{"groupId":"OG002","value":"0.91","spread":"42.2"}]}]}]},{"type":"SECONDARY","title":"Triglycerides as a Ratio to Baseline at 52 Weeks","description":"Triglycerides after 52 weeks of treatment was represented as ratio to baseline (week 0) values.","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". Missing data were imputed using last observation carried forward (LOCF) method.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio","timeFrame":"After 52 weeks of treatment","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.91","spread":"48.3"},{"groupId":"OG001","value":"0.96","spread":"44.2"},{"groupId":"OG002","value":"0.91","spread":"44.0"}]}]}]},{"type":"SECONDARY","title":"Free Fatty Acids as a Ratio to Baseline at 52 Weeks","description":"Free fatty acids after 52 weeks of treatment was represented as ratio to baseline (week 0) values.","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". Missing data were imputed using last observation carried forward (LOCF) method.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio","timeFrame":"After 52 weeks of treatment","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.74","spread":"60.8"},{"groupId":"OG001","value":"0.70","spread":"59.3"},{"groupId":"OG002","value":"0.93","spread":"49.5"}]}]}]},{"type":"SECONDARY","title":"Fasting C-peptide as a Ratio to Baseline at 52 Weeks","description":"Fasting C-peptide after 52 weeks of treatment was represented as ratio to baseline (week 0) values.","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio","timeFrame":"After 52 weeks of treatment","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"272"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.61","spread":"75.6"},{"groupId":"OG001","value":"0.42","spread":"82.6"},{"groupId":"OG002","value":"1.12","spread":"29.9"}]}]}]},{"type":"SECONDARY","title":"Fasting Human Insulin as a Ratio to Baseline at 52 Weeks","description":"Fasting human insulin after 52 weeks of treatment was represented as ratio to baseline (week 0) values.","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". Missing data were imputed using last observation carried forward (LOCF) method.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio","timeFrame":"After 52 weeks of treatment","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.90","spread":"89.0"},{"groupId":"OG001","value":"0.61","spread":"81.1"},{"groupId":"OG002","value":"1.52","spread":"66.6"}]}]}]},{"type":"SECONDARY","title":"Fasting Glucagon as a Ratio to Baseline at 52 Weeks","description":"Fasting glucagon after 52 weeks of treatment was represented as ratio to baseline (week 0) values.","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio","timeFrame":"After 52 weeks of treatment","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"272"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.95","spread":"27.9"},{"groupId":"OG001","value":"0.94","spread":"27.6"},{"groupId":"OG002","value":"0.96","spread":"25.7"}]}]}]},{"type":"SECONDARY","title":"Proinsulin as a Ratio to Baseline at 52 Weeks","description":"Proinsulin after 52 weeks of treatment was represented as ratio to baseline (week 0) values.","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation \"as randomised\". Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio","timeFrame":"After 52 weeks of treatment","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"270"},{"groupId":"OG001","value":"266"},{"groupId":"OG002","value":"264"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.18","spread":"231.5"},{"groupId":"OG001","value":"0.17","spread":"188.8"},{"groupId":"OG002","value":"0.59","spread":"85.9"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment Emergent Adverse Events (TEAEs)","description":"Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.","populationDescription":"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation \"as treated\".","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"0-52 weeks","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"873"},{"groupId":"OG001","value":"829"},{"groupId":"OG002","value":"885"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes","description":"Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.\n\nSevere or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were 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.\n\nSevere hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.","populationDescription":"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation \"as treated\".","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"0-52 weeks","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"135"},{"groupId":"OG001","value":"362"},{"groupId":"OG002","value":"136"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes","description":"Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. Nocturnal period: The period between 00:01 and 05:59 a.m. (both inclusive).\n\nSevere or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were 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.\n\nSevere hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.","populationDescription":"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation \"as treated\".","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"0-52 weeks","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA) Definition","description":"Results represent total number of treatment emergent hypoglycaemic episodes that fall under ADA's definition of hypoglycaemia. ADA's definition of hypoglycaemia includes following categories:\n\n1. Severe hypoglycaemia\n2. Documented symptomatic hypoglycaemia\n3. Asymptomatic hypoglycaemia\n4. Probable symptomatic hypoglycaemia\n5. Pseudo-hypoglycaemia. Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.","populationDescription":"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation \"as treated\".","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"0-52 weeks","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4830"},{"groupId":"OG001","value":"6340"},{"groupId":"OG002","value":"162"}]}]}]},{"type":"SECONDARY","title":"Anti-drug Antibodies: Anti-insulin Degludec Antibodies","description":"Insulin degludec (IDeg)-specific antibodies were measured at week 52, as %B/T (percentage of bound \\& precipitated radioactive drug/total added drug to the sample). A sample is measured in 2 different series. In series 1, the radioactive IDeg (tracer) and surplus unlabeled IDeg are added to the sample. In series 2, the tracer and surplus unlabeled human insulin are added to the sample. Series 1 represents unspecific background binding. Series 2 represents IDeg specific antibodies including unspecific background binding. The reported %B/T is calculated by subtracting the background %B/T in series 1 from the %B/T result in series 2. If the background result has higher values than the %B/T in series 2, the resulting value is negative %B/T. Here, a negative %B/T value means that the test samples do not have IDeg-specific antibodies. The reason for getting a negative value for %B/T is due to variation in the analytical background. Thus, the results presented are not a change from baseline.","populationDescription":"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation \"as treated\". Missing data were imputed using LOCF method. This endpoint is only applicable for subjects in IDegLira and IDeg arm.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage B/T","timeFrame":"at week 52","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.12","spread":"3.34"},{"groupId":"OG001","value":"-0.11","spread":"0.42"}]}]}]},{"type":"SECONDARY","title":"Anti-drug Antibodies: Number of Participants Positive or Negative for Anti-liraglutide Antibodies","description":"Anti-liraglutide antibodies were measured at week 52. Number of participants positive or negative for anti-liraglutide antibodies at week 52 were reported.","populationDescription":"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation \"as treated\". Missing data were imputed using LOCF method.This endpoint is only applicable for subjects in IDegLira and Lira arm.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"at week 52","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"273"}]}],"classes":[{"title":"Negative","categories":[{"measurements":[{"groupId":"OG000","value":"247"},{"groupId":"OG001","value":"224"}]}]},{"title":"Positive","categories":[{"measurements":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"49"}]}]}]},{"type":"SECONDARY","title":"Change in Clinical Evaluation: Fundoscopy or Fundus Photography","description":"The result of the fundus photography/dilated fundoscopy was interpreted by the investigator into following categories: Normal; Abnormal (Abn), Not Clinically significant (NCS); Abnormal, Clinically significant (CS). Reported results are number of subjects with 'normal'; 'Abn, NCS' and 'Abn, CS' fundoscopy/fundus photography results at screening (week -2 to week 0) and week 52.","populationDescription":"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation \"as treated\". Number Analyzed = subjects with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"at screening (week -2 to week 0), at week 52","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"classes":[{"title":"Left eye - at screening visit - normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"274"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"272"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"225"},{"groupId":"OG001","value":"213"},{"groupId":"OG002","value":"211"}]}]},{"title":"Left eye - at screening visit - Abn, NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"274"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"272"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"14"}]}]},{"title":"Left eye - at screening visit - Abn, CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"274"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"272"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"47"}]}]},{"title":"Left eye - week 52 - normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"274"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"272"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"217"},{"groupId":"OG001","value":"214"},{"groupId":"OG002","value":"212"}]}]},{"title":"Left eye - week 52 - Abn, NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"274"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"272"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"15"}]}]},{"title":"Left eye - week 52 - Abn, CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"274"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"272"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"41"},{"groupId":"OG002","value":"45"}]}]},{"title":"Right eye - at screening visit - normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"224"},{"groupId":"OG001","value":"212"},{"groupId":"OG002","value":"207"}]}]},{"title":"Right eye - at screening visit - Abn, NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"12"}]}]},{"title":"Right eye - at screening visit - Abn, CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"45"},{"groupId":"OG002","value":"54"}]}]},{"title":"Right eye - week 52 - normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"220"},{"groupId":"OG001","value":"217"},{"groupId":"OG002","value":"209"}]}]},{"title":"Right eye - week 52 - Abn, NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"15"}]}]},{"title":"Right eye - week 52 - Abn, CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"49"}]}]}]},{"type":"SECONDARY","title":"Change in Clinical Evaluation: Electrocardiogram (ECG)","description":"The result of the ECG was interpreted by the investigator into following categories: Normal; Abnormal (Abn), Not Clinically significant (NCS); Abnormal, Clinically significant (CS). Reported results are number of subjects with 'normal'; 'Abn, NCS' and 'Abn, CS' ECG results at screening (week -2 to week 0) and week 52.","populationDescription":"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation \"as treated\".","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"at screening (week -2 to week 0), at week 52","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"classes":[{"title":"At screening visit - normal","categories":[{"measurements":[{"groupId":"OG000","value":"228"},{"groupId":"OG001","value":"230"},{"groupId":"OG002","value":"222"}]}]},{"title":"At screening visit - Abn, NCS","categories":[{"measurements":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"38"},{"groupId":"OG002","value":"41"}]}]},{"title":"At screening visit - Abn, CS","categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"10"}]}]},{"title":"Week 52 - normal","categories":[{"measurements":[{"groupId":"OG000","value":"238"},{"groupId":"OG001","value":"232"},{"groupId":"OG002","value":"233"}]}]},{"title":"Week 52 - Abn, NCS","categories":[{"measurements":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"35"},{"groupId":"OG002","value":"34"}]}]},{"title":"Week 52 - Abn, CS","categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"6"}]}]}]},{"type":"SECONDARY","title":"Change in Clinical Evaluation: Pulse","description":"Change in pulse after 52 weeks of treatment.","populationDescription":"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation \"as treated\".","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"beats per minute","timeFrame":"Week 0, week 52","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"},{"groupId":"OG002","value":"273"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.9","spread":"9.5"},{"groupId":"OG001","value":"0.8","spread":"8.9"},{"groupId":"OG002","value":"4.2","spread":"9.1"}]}]}]},{"type":"SECONDARY","title":"Serum Concentrations of Insulin Degludec","description":"Samples from the IDegLira and IDeg arms were analysed for serum concentrations of insulin degludec using validated ELISA assays.","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). All subjects in FAS with at least one valid concentration value were included in the analysis. No imputations of missing concentration values were applied. Number Analyzed = subjects with available data. This endpoint is only applicable for subjects in IDegLira and IDeg arm.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"pmol/L","timeFrame":"Weeks 2, 8, 16, 26, 44, 52","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"271"}]}],"classes":[{"title":"At week 2","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"274"},{"groupId":"OG001","value":"270"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1468.7","spread":"55.9"},{"groupId":"OG001","value":"1477.1","spread":"61.3"}]}]},{"title":"At week 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"271"},{"groupId":"OG001","value":"267"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2246.0","spread":"72.2"},{"groupId":"OG001","value":"2524.6","spread":"71.5"}]}]},{"title":"At week 16","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"264"},{"groupId":"OG001","value":"262"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2511.0","spread":"83.6"},{"groupId":"OG001","value":"2856.4","spread":"84.4"}]}]},{"title":"At week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"264"},{"groupId":"OG001","value":"256"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2597.3","spread":"88.3"},{"groupId":"OG001","value":"2946.9","spread":"91.1"}]}]},{"title":"At week 44","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"254"},{"groupId":"OG001","value":"248"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2766.6","spread":"85.8"},{"groupId":"OG001","value":"3238.8","spread":"91.7"}]}]},{"title":"At week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"270"},{"groupId":"OG001","value":"266"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2393.8","spread":"116.7"},{"groupId":"OG001","value":"3124.4","spread":"101.2"}]}]}]},{"type":"SECONDARY","title":"Plasma Concentrations of Liraglutide","description":"Samples from the IDegLira and liraglutide arms were assayed for plasma concentrations of liraglutide using validated ELISA assays.","populationDescription":"Full Analysis Set (FAS) included all randomised subjects (819 subjects). All subjects in FAS with at least one valid concentration value were included in the analysis. No imputations of missing concentration values were applied. Number Analyzed = subjects with available data. This endpoint is only applicable for subjects in IDegLira and Lira arm.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"pmol/L","timeFrame":"Weeks 2, 8, 16, 26, 44, 52","groups":[{"id":"OG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."},{"id":"OG001","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"273"}]}],"classes":[{"title":"At week 2","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"274"},{"groupId":"OG001","value":"270"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5681.3","spread":"49.4"},{"groupId":"OG001","value":"6081.6","spread":"65.4"}]}]},{"title":"At week 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"271"},{"groupId":"OG001","value":"270"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"9107.8","spread":"61.4"},{"groupId":"OG001","value":"14539.5","spread":"71.0"}]}]},{"title":"At week 16","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"262"},{"groupId":"OG001","value":"268"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"10038.1","spread":"69.5"},{"groupId":"OG001","value":"14046.5","spread":"73.0"}]}]},{"title":"At week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"264"},{"groupId":"OG001","value":"267"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"9995.3","spread":"77.5"},{"groupId":"OG001","value":"13904.2","spread":"91.8"}]}]},{"title":"At week 44","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"253"},{"groupId":"OG001","value":"262"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"8791.7","spread":"81.0"},{"groupId":"OG001","value":"12855.6","spread":"112.7"}]}]},{"title":"At week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"269"},{"groupId":"OG001","value":"269"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"7426.2","spread":"103.5"},{"groupId":"OG001","value":"12127.4","spread":"142.4"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Week 0 (randomisation) to week 52 (end of treatment) and 7 days after end of treatment.","description":"Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.","eventGroups":[{"id":"EG000","title":"Insulin Degludec/Liraglutide","description":"Eligible subjects were treated with insulin degludec/liraglutide (IDegLira) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency; dose reduction was allowed in case of safety concern). The recommended starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide). IDegLira was titrated twice weekly according to a predefined titration algorithm to a maximum of 50 dose steps (50 units IDeg/1.8 mg liraglutide), aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). One follow-up visit was scheduled 7 days after end of treatment. IDegLira was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.","deathsNumAffected":1,"deathsNumAtRisk":275,"seriousNumAffected":17,"seriousNumAtRisk":275,"otherNumAffected":153,"otherNumAtRisk":275},{"id":"EG001","title":"Insulin Degludec","description":"Eligible subjects were treated with insulin degludec (IDeg) once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). The recommended starting dose of IDeg was 10 units. IDeg was titrated twice weekly according to a predefined titration algorithm, aiming to reach a fasting plasma glucose target between 72 mg/dL (4.0 mmol/L) and 90 mg/dL (5.0 mmol/L). There was no maximum dose decided for IDeg. One follow-up visit was scheduled 7 days after end of treatment. IDeg was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.","deathsNumAffected":0,"deathsNumAtRisk":271,"seriousNumAffected":13,"seriousNumAtRisk":271,"otherNumAffected":137,"otherNumAtRisk":271},{"id":"EG002","title":"Liraglutide","description":"Eligible subjects were treated with liraglutide once daily (OD) in combination with pre-trial oral anti diabetic drugs (at stable dose level and dosing frequency unless there were safety concerns, in which case dose reduction was allowed). For liraglutide the starting dose of liraglutide was 0.3 mg/day and subsequent weekly dose escalation by 0.3 mg weekly to a fixed maximum dose of 1.8 mg/day. One follow-up visit was scheduled 7 days after end of treatment. Liraglutide was injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection area chosen remained unchanged throughout the trial, although rotation within the area was recommended.","deathsNumAffected":0,"deathsNumAtRisk":273,"seriousNumAffected":14,"seriousNumAtRisk":273,"otherNumAffected":158,"otherNumAtRisk":273}],"seriousEvents":[{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 20","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":275},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":271},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":273}]},{"term":"Adrenal neoplasm","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 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