{"protocolSection":{"identificationModule":{"nctId":"NCT02505334","orgStudyIdInfo":{"id":"NN2211-4174"},"secondaryIdInfos":[{"id":"U1111-1164-5462","type":"OTHER","domain":"WHO"},{"id":"JapicCTI-152975","type":"REGISTRY","domain":"JAPIC"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"A Trial Comparing the Efficacy and Safety of Liraglutide 1.8 mg/Day to Liraglutide 0.9 mg/Day in Japanese Subjects With Type 2 Diabetes Mellitus.","officialTitle":"A Trial Comparing the Efficacy and Safety of Liraglutide 1.8 mg/Day to Liraglutide 0.9 mg/Day in Japanese Subjects With Type 2 Diabetes Mellitus"},"statusModule":{"statusVerifiedDate":"2018-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2015-07-21","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2017-05-02","type":"ACTUAL"},"completionDateStruct":{"date":"2017-11-09","type":"ACTUAL"},"studyFirstSubmitDate":"2015-07-21","studyFirstSubmitQcDate":"2015-07-21","studyFirstPostDateStruct":{"date":"2015-07-22","type":"ESTIMATED"},"resultsFirstSubmitDate":"2018-04-26","resultsFirstSubmitQcDate":"2018-06-20","resultsFirstPostDateStruct":{"date":"2018-06-25","type":"ACTUAL"},"lastUpdateSubmitDate":"2018-07-31","lastUpdatePostDateStruct":{"date":"2018-09-05","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":true},"descriptionModule":{"briefSummary":"This trial is conducted in Asia. The aim of the trial is to compare the efficacy and safety of liraglutide 1.8 mg/day to liraglutide 0.9 mg/day 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":635,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Liraglutide 1.8 mg","type":"EXPERIMENTAL","description":"The total trial duration for the 1.8 mg/day treatment arm will be approximately 67 weeks, consisting of 2 weeks screening period, a 12 weeks run-in period, a 26-week main treatment period, a safety extension period of 26 weeks and a follow-up visit.","interventionNames":["Drug: liraglutide"]},{"label":"Liraglutide 0.9 mg","type":"ACTIVE_COMPARATOR","description":"The total trial duration for the 0.9 mg/day treatment arm will be approximately 41 weeks, consisting of 2 weeks screening period, a 12 weeks run-in period, a 26-week treatment period, and a follow-up visit.","interventionNames":["Drug: liraglutide"]}],"interventions":[{"type":"DRUG","name":"liraglutide","description":"Injected subcutaneously s.c. (under the skin) once daily.","armGroupLabels":["Liraglutide 0.9 mg","Liraglutide 1.8 mg"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Glycosylated Haemoglobin (HbA1c) (Week 26)","description":"Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated after 26 weeks of treatment. The change from baseline in the response after 26 weeks of treatment is analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline response as a covariate.","timeFrame":"Week 0, Week 26"}],"secondaryOutcomes":[{"measure":"Change in HbA1c (Week 52)","description":"Change from baseline (week 0) in HbA1c was evaluated after 52 weeks of treatment.","timeFrame":"Week 0, Week 52"},{"measure":"Responder for HbA1c Below 7.0% (53 mmol/Mol)","description":"Reported results are number of subjects who achieved HbA1c target below 7.0% after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 26 and Week 52"},{"measure":"Responder for HbA1c Below or Equal to 6.5% (48 mmol/Mol)","description":"Reported results are number of subjects who achieved HbA1c target below or equal to 6.5% after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 26 and Week 52"},{"measure":"Responder for HbA1c Below 7.0% Without Weight Gain","description":"Reported results are number of subjects who achieved HbA1c target below 7.0% without weight gain after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 26 and Week 52"},{"measure":"Responder for HbA1c Below 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes","description":"Reported results are subjects with HbA1c \\<7.0% after 26 weeks and 52 weeks of treatment, respectively without treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes. Severe or BG confirmed symptomatic hypoglycaemia: severe as per ADA classification or BG confirmed by plasma glucose (PG) value \\<3.1 mmol/L with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA: episode requiring assistance of another person to actively administer carbohydrate/glucagon, or take other corrective actions. PG levels may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG level. Treatment emergent: episode with onset date on or after randomisation (from week (wk)0) and no later than 7 days after the last day on liraglutide (maximum till wk26+7days and wk52+7days). Hence, the following shown 'Time Frame' should be read as 'Wk26+7days and Wk52+7days'","timeFrame":"Week 26 and Week 52"},{"measure":"Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)","description":"Reported results are 7-point SMBG values at week 0, week 26 and week 52. The 7-point profile blood glucose levels were measured at the following time points always starting with the first:\n\n1. Before breakfast.\n2. 90 minutes after start of breakfast.\n3. Before lunch.\n4. 90 minutes after start of lunch.\n5. Before dinner.\n6. 90 minutes after start of dinner.\n7. At bedtime.","timeFrame":"Week 0 and Week 26 and Week 52"},{"measure":"Change in SMBG 7-point Profile: Mean of 7-point Profile","description":"Change from baseline (week 0) in mean of the SMBG 7-point profile was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26, Week 52"},{"measure":"Change in SMBG 7-point Profile: Mean of Postprandial Increments (From Before Meal to 90 Minutes After for Breakfast, Lunch and Dinner)","description":"Change from baseline (week 0) in mean of postprandial increments (from before meal to 90 minutes after for breakfast, lunch and dinner) of the SMBG 7-point profile was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26, Week 52"},{"measure":"Change in Fasting Plasma Glucose (FPG)","description":"Change from baseline (week 0) in FPG was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26, Week 52"},{"measure":"Change in Waist Circumference","description":"Change from baseline (week 0) in waist circumference was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26, Week 52"},{"measure":"Change in Body Weight","description":"Change from baseline (week 0) in body weight was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26, Week 52"},{"measure":"Change in Body Mass Index (BMI)","description":"Change from baseline (week 0) in BMI was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26, Week 52"},{"measure":"Change in Blood Pressure (Systolic and Diastolic)","description":"Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26, Week 52"},{"measure":"Fasting C-peptide","description":"Fasting C-peptide was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 26 and Week 52"},{"measure":"Fasting Insulin","description":"Fasting insulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 26 and Week 52"},{"measure":"Fasting Glucagon","description":"Fasting glucagon was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 26 and Week 52"},{"measure":"Proinsulin","description":"Proinsulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 26 and Week 52"},{"measure":"Proinsulin/Insulin","description":"Proinsulin/insulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 26 and Week 52"},{"measure":"Homeostasis Model Assessment of Beta-cell Function (HOMA-B)","description":"HOMA-B was evaluated after 26 weeks and 52 weeks of treatment, respectively. HOMA-B is an index of beta-cell function and was calculated as: HOMA-B=\\[(20 x fasting insulin in µU/mL)/(FPG in mmol/L-3.5)\\].","timeFrame":"Week 26 and Week 52"},{"measure":"Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)","description":"HOMA-IR was evaluated after 26 weeks and 52 weeks of treatment, respectively. HOMA-IR is an index of insulin resistance and was calculated as: HOMA-IR= fasting insulin (μU/mL) x FPG (mmol/L)/22.5.","timeFrame":"Week 26 and Week 52"},{"measure":"Total Cholesterol","description":"Total cholesterol was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 26 and Week 52"},{"measure":"Low Density Lipoprotein (LDL) Cholesterol","description":"LDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 26 and Week 52"},{"measure":"High Density Lipoprotein (HDL) Cholesterol","description":"HDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 26 and Week 52"},{"measure":"Very Low Density Lipoprotein (VLDL) Cholesterol","description":"VLDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 26 and Week 52"},{"measure":"Triglycerides","description":"Triglycerides were evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 26 and Week 52"},{"measure":"Free Fatty Acids","description":"Free fatty acids were evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 26 and Week 52"},{"measure":"Number of Treatment Emergent Adverse Events","description":"Treatment emergent adverse events (TEAEs) were evaluated during the 26-week and 52-week treatment period, respectively. TEAE for weeks 0-26: Event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 + 7 days). TEAE for weeks 0-52: Event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 52 + 7 days). Hence, the following shown 'Time Frame' should be read as 'Weeks 0-26 + 7 days and Weeks 0-52 + 7 days'.","timeFrame":"Weeks 0-26 and Weeks 0-52"},{"measure":"Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes","description":"Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were evaluated during the 26-week and 52-week treatment period, respectively. Severe or BG confirmed symptomatic hypoglycaemia (hypo):An episode that was severe according to the ADA classification or BG confirmed by a PG value \\<3.1 mmol/L with symptoms consistent with hypo. ADA definition of severe hypo:episode requiring assistance of another person to actively administer carbohydrate/glucagon, or take other corrective actions. PG levels may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG level. Treatment emergent: episode with onset date on or after randomisation (from week (wk) 0) and no later than 7 days after the last day on liraglutide (maximum till wk 26 and wk 52, respectively + 7 days). Hence, the following shown 'Time Frame' should be read as 'wk 0-26+7 days and wk 0-52+7 days'.","timeFrame":"Weeks 0-26 and Weeks 0-52"},{"measure":"Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes","description":"Treatment emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes were evaluated during the26-week and 52-week treatment period, respectively. Nocturnal hypoglycaemic episodes: Those occurring between 00:01 and 05:59 hours, both inclusive. Severe or BG confirmed symptomatic hypoglycaemia: episode that was severe according to the ADA classification or BG confirmed by a PG value \\<3.1 mmol/L with symptoms consistent with hypoglycaemia. Treatment emergent: episode with onset date on or after randomisation (from week 0) and no later than 7 days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Hence, the following shown 'Time Frame' should be read as 'Week 0-26 + 7 days and Week 0-52 + 7 days'.","timeFrame":"Weeks 0-26 and Weeks 0-52"},{"measure":"Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition","description":"American Diabetes Association (ADA) classification of hypoglycaemia:\n\n1. Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level.\n2. Documented symptomatic: PG level ≤3.9 mmol/L with symptoms.\n3. Asymptomatic: PG level ≤3.9 mmol/L without symptoms.\n4. Probable symptomatic: No measurement with symptoms.\n5. Pseudo: PG level \\>3.9 mmol/L with symptoms. Treatment emergent hypoglycaemic episode: episode with onset date on or after randomisation (from week 0) and no later than 7 days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Hence, the following shown 'Time Frame' should be read as 'Week 0-26 + 7 days and Week 0-52 + 7 days'.","timeFrame":"Weeks 0-26 and Weeks 0-52"},{"measure":"Change in Pulse","description":"Change from baseline (week 0) in pulse was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26, Week 52"},{"measure":"Change in Physical Examination","description":"Reported results are physical examination outcomes at week (wk) 0, wk 26 and wk 52. Physical examination consisted of the following listed examinations and the outcome of each examination was evaluated as: 1) normal, 2) abnormal, not clinically significant (NCS) or 3) abnormal, clinically significant (CS).\n\n1. Cardiovascular system\n2. Central and peripheral nervous system (PNS)\n3. Gastrointestinal (GI) system including mouth\n4. General appearance\n5. Head, ears, eyes, nose, throat, neck\n6. Lymph node palpation\n7. Musculoskeletal system\n8. Respiratory system\n9. Skin\n10. Thyroid gland","timeFrame":"Week 0 and Week 26 and Week 52"},{"measure":"Change in Eye Examination","description":"Reported results are eye examination (ophthalmoscopy) outcomes at week 0, week 26 and week 52. Ophthalmoscopy outcomes for both left and right eye were evaluated as: 1) normal, 2) abnormal, NCS or 3) abnormal, CS.","timeFrame":"Week 0 and Week 26 and Week 52"},{"measure":"Change in Electrocardiogram (ECG)","description":"Reported results are ECG outcomes at week 0, week 26 and week 52. ECG outcomes were evaluated as: 1) normal, 2) abnormal, NCS or 3) abnormal, CS.","timeFrame":"Week 0 and Week 26 and Week 52"},{"measure":"Change in Biochemistry: Creatinine","description":"Change from baseline (week 0) in creatinine was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26, Week 52"},{"measure":"Change in Biochemistry: eGFR","description":"Change from baseline (week 0) in estimated glomerular filtration rate (eGFR) was evaluated after 26 weeks and 52 weeks of treatment, respectively. eGFR was evaluated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, mL/min/1.73m\\^2.","timeFrame":"Week 0, Week 26, Week 52"},{"measure":"Change in Biochemistry: Alanine Aminotransferase","description":"Change from baseline (week 0) in alanine aminotransferase was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26, Week 52"},{"measure":"Change in Biochemistry: Aspartate Aminotransferase","description":"Change from baseline (week 0) in aspartate aminotransferase was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26, Week 52"},{"measure":"Change in Biochemistry: Alkaline Phosphatase","description":"Change from baseline (week 0) in alkaline phosphatase was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26, Week 52"},{"measure":"Change in Biochemistry: Sodium","description":"Change from baseline (week 0) in sodium was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26, Week 52"},{"measure":"Change in Biochemistry: Potassium","description":"Change from baseline (week 0) in potassium was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26, Week 52"},{"measure":"Change in Biochemistry: Albumin","description":"Change from baseline (week 0) in albumin was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26, Week 52"},{"measure":"Change in Biochemistry: Total Bilirubin","description":"Change from baseline (week 0) in total bilirubin was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26, Week 52"},{"measure":"Change in Biochemistry: Urea","description":"Change from baseline (week 0) in urea was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26, Week 52"},{"measure":"Change in Biochemistry: Creatine Kinase","description":"Change from baseline (week 0) in creatine kinase was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26, Week 52"},{"measure":"Change in Biochemistry: Calcium","description":"Change from baseline (week 0) in calcium was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26, Week 52"},{"measure":"Change in Biochemistry: Albumin Corrected Calcium","description":"Change from baseline (week 0) in albumin corrected calcium was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26, Week 52"},{"measure":"Change in Biochemistry: Amylase","description":"Change from baseline (week 0) in amylase was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26, Week 52"},{"measure":"Change in Biochemistry: Lipase","description":"Change from baseline (week 0) in lipase was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26, Week 52"},{"measure":"Change in Haematology: Haemoglobin","description":"Change from baseline (week 0) in haemoglobin was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26, Week 52"},{"measure":"Change in Haematology: Haematocrit","description":"Change from baseline (week 0) in haematocrit was evaluated after 26 weeks and 52 weeks of treatment, respectively. Haematocrit is the ratio of the volume of red blood cells to the total volume of blood.","timeFrame":"Week 0, Week 26, Week 52"},{"measure":"Change in Haematology: Thrombocytes","description":"Change from baseline (week 0) in thrombocytes (platelets) was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26 and Week 52"},{"measure":"Change in Haematology: Erythrocytes","description":"Change from baseline (week 0) in erythrocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26 and Week 52"},{"measure":"Change in Haematology: Leukocytes","description":"Change from baseline (week 0) in leukocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26 and Week 52"},{"measure":"Change in Haematology: Eosinophils","description":"Change from baseline (week 0) in eosinophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26 and Week 52"},{"measure":"Change in Haematology: Neutrophils","description":"Change from baseline (week 0) in neutrophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26 and Week 52"},{"measure":"Change in Haematology: Basophils","description":"Change from baseline (week 0) in basophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26 and Week 52"},{"measure":"Change in Haematology: Monocytes","description":"Change from baseline (week 0) in monocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26 and Week 52"},{"measure":"Change in Haematology: Lymphocytes","description":"Change from baseline (week 0) in lymphocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.","timeFrame":"Week 0, Week 26 and Week 52"},{"measure":"Change in Calcitonin","description":"Reported results are number of subjects with low, normal or high calcitonin values at week 0, week 26 and week 52. Number of subjects analyzed = number of subjects contributed to the analysis for individual time point. Calcitonin values were categorised as low, normal or high.","timeFrame":"Week 0 and Week 26 and Week 52"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female Japanese subjects at least 20 years of age at the time of informed consent\n* Type 2 diabetes subjects (diagnosed clinically) for at least 6 months prior to screening\n* HbA1c 7.5-10.0% \\[58 mmol/mol-86 mmol/mol\\] (both inclusive)\n* Subjects on stable therapy with one OAD (oral antidiabetic drug) (stable therapy is defined as unchanged medication and unchanged dose) for for at least 60 days before screening according to approved Japanese labelling\n\nExclusion Criteria:\n\n* Treatment with insulin within 12 weeks prior to screening\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* Screening calcitonin equal 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\n* Within the past 180 days any of the following: myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack\n* Diagnosis of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer, polyps and in-situ carcinomas)\n* Any condition which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol","healthyVolunteers":false,"sex":"ALL","minimumAge":"20 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Clinical Reporting Anchor and Disclosure 1452","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Novo Nordisk Investigational Site","city":"Annaka-shi, Gunma","zip":"379 0116","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":"103-0027","country":"Japan"},{"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 0027","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":"Fukuoka-shi, Fukuoka","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Higashiosaka-shi, Osaka","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"Novo Nordisk Investigational Site","city":"Hokkaido","zip":"078-8236","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Ichikawa-shi, Chiba","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":"Izumisano","zip":"598 0048","country":"Japan","geoPoint":{"lat":34.41667,"lon":135.31667}},{"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":"Kobe-shi, Hyogo","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Kumamoto-shi,Kumamoto","zip":"862 0976","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Mito-shi, Ibaraki","zip":"310-0845","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Mito-shi, Ibaraki","country":"Japan"},{"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":"Naka-shi, Ibaraki","zip":"311 0113","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Neyagawa-shi, Osaka","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Nishinomiya-shi, Hygo","zip":"662 0971","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Nishinomiya-shi, Hyogo","zip":"663-8501","country":"Japan","geoPoint":{"lat":43.36667,"lon":144.43333}},{"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":"Osaka-shi, Osaka","zip":"553 0003","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Osaka-shi, Osaka","zip":"5590012","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Oyama-shi, Tochigi","zip":"323 0022","country":"Japan","geoPoint":{"lat":36.38333,"lon":139.73333}},{"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":"Saga-shi,Saga","zip":"849 0937","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Sapporo-shi, Hokkaido","zip":"060 0062","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 Investigational Site","city":"Sapporo-shi, Hokkaido","zip":"062 0007","country":"Japan","geoPoint":{"lat":43.06667,"lon":141.35}},{"facility":"Novo Nordisk Investigational Site","city":"Sappro-shi, Hokkaido","zip":"060 8648","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Shimotsuke-shi, Tochigi","zip":"329 0433","country":"Japan","geoPoint":{"lat":36.38333,"lon":139.73333}},{"facility":"Novo Nordisk Investigational Site","city":"Shinjuku-ku, Tokyo","zip":"160-0008","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}},{"facility":"Novo Nordisk Investigational Site","city":"Shizuoka","zip":"424 0853","country":"Japan","geoPoint":{"lat":34.98333,"lon":138.38333}},{"facility":"Novo Nordisk Investigational Site","city":"Suita-shi, Osaka","zip":"565-0853","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"Novo Nordisk Investigational Site","city":"Takatsuki-shi, Osaka","zip":"569 1096","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"Novo Nordisk Investigational Site","city":"Tokyo","zip":"103-0028","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}},{"facility":"Novo Nordisk Investigational Site","city":"Tokyo","zip":"105-8471","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}},{"facility":"Novo Nordisk Investigational Site","city":"Tokyo","zip":"123-0845","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}},{"facility":"Novo Nordisk Investigational Site","city":"Tokyo","zip":"144-0051","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}},{"facility":"Novo Nordisk Investigational Site","city":"Tokyo","zip":"169-0073","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}},{"facility":"Novo Nordisk Investigational Site","city":"Tokyo","zip":"181-0013","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}},{"facility":"Novo Nordisk Investigational Site","city":"Yokohama","zip":"235 0045","country":"Japan","geoPoint":{"lat":35.43333,"lon":139.65}},{"facility":"Novo Nordisk Investigational Site","city":"Yokohama, Kanagawa","zip":"236-0004","country":"Japan"},{"facility":"Novo Nordisk Investigational Site","city":"Yokohama-shi Kanagawa","zip":"232-0064","country":"Japan"}]},"referencesModule":{"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","url":"http://www.novonordisk-trials.com/website/content/how-to-access-clinical-trial-datasets.aspx"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Subjects received liraglutide 0.9 mg/day (starting with 0.3 mg/day with subsequent weekly dose escalation of 0.3 mg to a maximum 0.9 mg/day) during 12 weeks run-in period. Subjects with HbA1c ≥7.0% at the end of run-in period were randomised (1:1) to two treatment arms: continuing liraglutide 0.9 mg/day or dose escalation to liraglutide 1.8 mg/day.","recruitmentDetails":"The trial was conducted at 47 sites in Japan: 47 sites screened and 45 of them randomised subjects. After screening, 635 subjects entered into the 12-week run-in period.","groups":[{"id":"FG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily subcutaneous (s.c.; under the skin) injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"FG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"periods":[{"title":"Main Treatment Period","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"233"},{"groupId":"FG001","numSubjects":"233"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"218"},{"groupId":"FG001","numSubjects":"194"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"39"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"17"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"8"}]},{"type":"Unclassified","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"10"}]}]},{"title":"Extension Treatment Period","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"6 subjects withdrew from the trial after the main period and prior to entering the extension period","numSubjects":"212"},{"groupId":"FG001","comment":"This treatment arm is not considered for this period as the subjects were treated for 26 weeks","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"194"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Unclassified","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Full analysis set (FAS), which included all randomised subjects.","groups":[{"id":"BG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"BG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"233"},{"groupId":"BG001","value":"233"},{"groupId":"BG002","value":"466"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"55.07","spread":"10.27"},{"groupId":"BG001","value":"54.96","spread":"10.61"},{"groupId":"BG002","value":"55.01","spread":"10.43"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"77"},{"groupId":"BG001","value":"68"},{"groupId":"BG002","value":"145"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"156"},{"groupId":"BG001","value":"165"},{"groupId":"BG002","value":"321"}]}]}]},{"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"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"233"},{"groupId":"BG001","value":"233"},{"groupId":"BG002","value":"466"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Glycosylated haemoglobin (HbA1c)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Percentage (%) of HbA1c","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.14","spread":"1.02"},{"groupId":"BG001","value":"8.10","spread":"0.87"},{"groupId":"BG002","value":"8.12","spread":"0.95"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Glycosylated Haemoglobin (HbA1c) (Week 26)","description":"Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated after 26 weeks of treatment. The change from baseline in the response after 26 weeks of treatment is analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline response as a covariate.","populationDescription":"FAS, which included all randomised subjects. Missing values were imputed using the last observation carried forward (LOCF) method.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percentage (%) of HbA1c","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.23","spread":"0.06"},{"groupId":"OG001","value":"0.17","spread":"0.06"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Missing data was imputed using the LOCF method. The change from baseline in the response after 26 weeks of treatment was analysed using an ANCOVA model with treatment as a fixed effect and baseline response as a covariate.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Superiority of liraglutide 1.8 mg/day vs. liraglutide 0.9 mg/day was to be considered confirmed if the 95% confidence interval for the treatment difference (liraglutide 1.8 mg/day minus liraglutide 0.9 mg/day) for change from baseline in HbA1c (% of HbA1c) was entirely below 0%, equivalent to a one-sided test with significance level of 2.5%.","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"Treatment difference","paramValue":"-0.40","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.55","ciUpperLimit":"-0.24"}]},{"type":"SECONDARY","title":"Change in HbA1c (Week 52)","description":"Change from baseline (week 0) in HbA1c was evaluated after 52 weeks of treatment.","populationDescription":"FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for this outcome measure, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage (%) of HbA1c","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"}]}],"classes":[{"title":"Week 0: Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"8.14","spread":"1.02"}]}]},{"title":"Week 52: Change from baseline","categories":[{"measurements":[{"groupId":"OG000","value":"-0.09","spread":"1.05"}]}]}]},{"type":"SECONDARY","title":"Responder for HbA1c Below 7.0% (53 mmol/Mol)","description":"Reported results are number of subjects who achieved HbA1c target below 7.0% after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing HbA1c values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26 and Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"18"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"45"}]}]}]},{"type":"SECONDARY","title":"Responder for HbA1c Below or Equal to 6.5% (48 mmol/Mol)","description":"Reported results are number of subjects who achieved HbA1c target below or equal to 6.5% after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing HbA1c values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26 and Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"5"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"16"}]}]}]},{"type":"SECONDARY","title":"Responder for HbA1c Below 7.0% Without Weight Gain","description":"Reported results are number of subjects who achieved HbA1c target below 7.0% without weight gain after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing HbA1c and body weight values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26 and Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"13"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"35"}]}]}]},{"type":"SECONDARY","title":"Responder for HbA1c Below 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes","description":"Reported results are subjects with HbA1c \\<7.0% after 26 weeks and 52 weeks of treatment, respectively without treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes. Severe or BG confirmed symptomatic hypoglycaemia: severe as per ADA classification or BG confirmed by plasma glucose (PG) value \\<3.1 mmol/L with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA: episode requiring assistance of another person to actively administer carbohydrate/glucagon, or take other corrective actions. PG levels may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG level. Treatment emergent: episode with onset date on or after randomisation (from week (wk)0) and no later than 7 days after the last day on liraglutide (maximum till wk26+7days and wk52+7days). Hence, the following shown 'Time Frame' should be read as 'Wk26+7days and Wk52+7days'","populationDescription":"FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing HbA1c values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26 and Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"18"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"45"}]}]}]},{"type":"SECONDARY","title":"Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)","description":"Reported results are 7-point SMBG values at week 0, week 26 and week 52. The 7-point profile blood glucose levels were measured at the following time points always starting with the first:\n\n1. Before breakfast.\n2. 90 minutes after start of breakfast.\n3. Before lunch.\n4. 90 minutes after start of lunch.\n5. Before dinner.\n6. 90 minutes after start of dinner.\n7. At bedtime.","populationDescription":"FAS, which included all randomised subjects. Number analyzed = number of subjects contributed to the analysis. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg/dL","timeFrame":"Week 0 and Week 26 and Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 0: Before breakfast","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"232"},{"groupId":"OG001","value":"232"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"181.8","spread":"42.8"},{"groupId":"OG001","value":"177.1","spread":"43.4"}]}]},{"title":"Week 0: 90 minutes after start of breakfast","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"230"},{"groupId":"OG001","value":"230"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"262.6","spread":"65.0"},{"groupId":"OG001","value":"266.5","spread":"70.0"}]}]},{"title":"Week 0: Before lunch","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"232"},{"groupId":"OG001","value":"230"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"169.5","spread":"57.7"},{"groupId":"OG001","value":"177.6","spread":"61.7"}]}]},{"title":"Week 0: 90 minutes after start of lunch","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"230"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"253.1","spread":"64.5"},{"groupId":"OG001","value":"252.2","spread":"63.5"}]}]},{"title":"Week 0: Before dinner","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"230"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"173.4","spread":"59.2"},{"groupId":"OG001","value":"169.7","spread":"56.5"}]}]},{"title":"Week 0: 90 minutes after start of dinner","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"232"},{"groupId":"OG001","value":"229"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"254.3","spread":"66.2"},{"groupId":"OG001","value":"249.5","spread":"63.2"}]}]},{"title":"Week 0: At bedtime","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"230"},{"groupId":"OG001","value":"228"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"226.1","spread":"67.4"},{"groupId":"OG001","value":"217.8","spread":"58.7"}]}]},{"title":"Week 26: Before breakfast","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"232"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"171.7","spread":"39.6"},{"groupId":"OG001","value":"178.2","spread":"44.4"}]}]},{"title":"Week 26: 90 minutes after start of breakfast","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"232"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"247.2","spread":"64.6"},{"groupId":"OG001","value":"258.2","spread":"63.7"}]}]},{"title":"Week 26: Before lunch","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"232"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"161.2","spread":"51.0"},{"groupId":"OG001","value":"177.0","spread":"57.9"}]}]},{"title":"Week 26: 90 minutes after start of lunch","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"232"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"234.7","spread":"63.3"},{"groupId":"OG001","value":"255.3","spread":"66.7"}]}]},{"title":"Week 26: Before dinner","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"232"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"162.3","spread":"47.5"},{"groupId":"OG001","value":"168.6","spread":"57.5"}]}]},{"title":"Week 26: 90 minutes after start of dinner","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"232"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"233.3","spread":"60.1"},{"groupId":"OG001","value":"251.5","spread":"64.9"}]}]},{"title":"Week 26: At bedtime","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"232"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"205.6","spread":"58.6"},{"groupId":"OG001","value":"220.5","spread":"68.8"}]}]},{"title":"Week 52: Before breakfast","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"232"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"176.1","spread":"43.2"}]}]},{"title":"Week 52: 90 minutes after start of breakfast","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"229"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"251.1","spread":"69.1"}]}]},{"title":"Week 52: Before lunch","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"169.6","spread":"59.7"}]}]},{"title":"Week 52: 90 minutes after start of lunch","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"243.3","spread":"63.9"}]}]},{"title":"Week 52: Before dinner","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"232"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"164.3","spread":"50.8"}]}]},{"title":"Week 52: 90 minutes after start of dinner","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"230"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"240.5","spread":"65.8"}]}]},{"title":"Week 52: At bedtime","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"230"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"207.9","spread":"66.7"}]}]}]},{"type":"SECONDARY","title":"Change in SMBG 7-point Profile: Mean of 7-point Profile","description":"Change from baseline (week 0) in mean of the SMBG 7-point profile was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"FAS, which included all randomised subjects. Number analyzed = number of subjects contributed to the analysis. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg/dL","timeFrame":"Week 0, Week 26, Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Baseline (week 0)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"232"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"217.9","spread":"46.7"},{"groupId":"OG001","value":"217.7","spread":"46.8"}]}]},{"title":"Change from baseline: week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"232"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-14.5","spread":"39.0"},{"groupId":"OG001","value":"-0.6","spread":"45.0"}]}]},{"title":"Change from baseline: week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"232"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-8.9","spread":"43.7"}]}]}]},{"type":"SECONDARY","title":"Change in SMBG 7-point Profile: Mean of Postprandial Increments (From Before Meal to 90 Minutes After for Breakfast, Lunch and Dinner)","description":"Change from baseline (week 0) in mean of postprandial increments (from before meal to 90 minutes after for breakfast, lunch and dinner) of the SMBG 7-point profile was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"FAS, which included all randomised subjects. Number analyzed = number of subjects contributed to the analysis. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg/dL","timeFrame":"Week 0, Week 26, Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 0: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"232"},{"groupId":"OG001","value":"232"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"81.7","spread":"38.7"},{"groupId":"OG001","value":"81.6","spread":"38.6"}]}]},{"title":"Week 26: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"232"},{"groupId":"OG001","value":"232"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-8.4","spread":"43.8"},{"groupId":"OG001","value":"-1.5","spread":"39.5"}]}]},{"title":"Week 52: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"232"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-6.3","spread":"44.4"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose (FPG)","description":"Change from baseline (week 0) in FPG was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg/dL","timeFrame":"Week 0, Week 26, Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 0: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"172.5","spread":"38.7"},{"groupId":"OG001","value":"172.0","spread":"38.3"}]}]},{"title":"Week 26: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-8.4","spread":"36.7"},{"groupId":"OG001","value":"1.0","spread":"33.7"}]}]},{"title":"Week 52: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.2","spread":"39.0"}]}]}]},{"type":"SECONDARY","title":"Change in Waist Circumference","description":"Change from baseline (week 0) in waist circumference was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Centimeter (cm)","timeFrame":"Week 0, Week 26, Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 0: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"93.68","spread":"11.75"},{"groupId":"OG001","value":"93.82","spread":"11.50"}]}]},{"title":"Week 26: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.44","spread":"3.04"},{"groupId":"OG001","value":"-0.73","spread":"3.03"}]}]},{"title":"Week 52: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.07","spread":"3.64"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight","description":"Change from baseline (week 0) in body weight was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilogram (kg)","timeFrame":"Week 0, Week 26, Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 0: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"74.67","spread":"15.24"},{"groupId":"OG001","value":"75.13","spread":"16.46"}]}]},{"title":"Week 26: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.77","spread":"2.01"},{"groupId":"OG001","value":"-0.95","spread":"2.19"}]}]},{"title":"Week 52: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.05","spread":"2.26"}]}]}]},{"type":"SECONDARY","title":"Change in Body Mass Index (BMI)","description":"Change from baseline (week 0) in BMI was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kg/m^2","timeFrame":"Week 0, Week 26, Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 0: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"27.34","spread":"4.80"},{"groupId":"OG001","value":"27.20","spread":"4.72"}]}]},{"title":"Week 26: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.28","spread":"0.72"},{"groupId":"OG001","value":"-0.33","spread":"0.78"}]}]},{"title":"Week 52: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.39","spread":"0.82"}]}]}]},{"type":"SECONDARY","title":"Change in Blood Pressure (Systolic and Diastolic)","description":"Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmHg","timeFrame":"Week 0, Week 26, Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 0: SBP, Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"128.0","spread":"13.1"},{"groupId":"OG001","value":"128.8","spread":"13.1"}]}]},{"title":"Week 26: SBP, change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.7","spread":"12.8"},{"groupId":"OG001","value":"0.4","spread":"12.2"}]}]},{"title":"Week 52: SBP, change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.9","spread":"12.5"}]}]},{"title":"Week 0: DBP, Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"79.6","spread":"9.1"},{"groupId":"OG001","value":"80.3","spread":"9.8"}]}]},{"title":"Week 26: DBP, change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.9","spread":"8.7"},{"groupId":"OG001","value":"0.1","spread":"7.8"}]}]},{"title":"Week 52: DBP, change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.6","spread":"8.4"}]}]}]},{"type":"SECONDARY","title":"Fasting C-peptide","description":"Fasting C-peptide was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng/mL","timeFrame":"Week 26 and Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.946","spread":"41.9"},{"groupId":"OG001","value":"1.853","spread":"40.8"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.906","spread":"42.2"}]}]}]},{"type":"SECONDARY","title":"Fasting Insulin","description":"Fasting insulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"pmol/L","timeFrame":"Week 26 and Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"77.00","spread":"70.9"},{"groupId":"OG001","value":"70.91","spread":"65.3"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"77.31","spread":"68.7"}]}]}]},{"type":"SECONDARY","title":"Fasting Glucagon","description":"Fasting glucagon was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"pmol/L","timeFrame":"Week 26 and Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"22.5","spread":"30.0"},{"groupId":"OG001","value":"23.4","spread":"26.8"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"23.4","spread":"30.2"}]}]}]},{"type":"SECONDARY","title":"Proinsulin","description":"Proinsulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"pmol/L","timeFrame":"Week 26 and Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"15.638","spread":"111.2"},{"groupId":"OG001","value":"16.054","spread":"101.8"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"16.217","spread":"107.4"}]}]}]},{"type":"SECONDARY","title":"Proinsulin/Insulin","description":"Proinsulin/insulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Percentage (%) of proinsulin/insulin","timeFrame":"Week 26 and Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"20.31","spread":"70.7"},{"groupId":"OG001","value":"22.64","spread":"70.6"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"20.98","spread":"72.5"}]}]}]},{"type":"SECONDARY","title":"Homeostasis Model Assessment of Beta-cell Function (HOMA-B)","description":"HOMA-B was evaluated after 26 weeks and 52 weeks of treatment, respectively. HOMA-B is an index of beta-cell function and was calculated as: HOMA-B=\\[(20 x fasting insulin in µU/mL)/(FPG in mmol/L-3.5)\\].","populationDescription":"FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Percentage (%) of beta-cell function","timeFrame":"Week 26 and Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"42.06","spread":"73.0"},{"groupId":"OG001","value":"35.54","spread":"72.9"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"40.03","spread":"79.5"}]}]}]},{"type":"SECONDARY","title":"Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)","description":"HOMA-IR was evaluated after 26 weeks and 52 weeks of treatment, respectively. HOMA-IR is an index of insulin resistance and was calculated as: HOMA-IR= fasting insulin (μU/mL) x FPG (mmol/L)/22.5.","populationDescription":"FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"HOMA-IR score","timeFrame":"Week 26 and Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4.388","spread":"81.9"},{"groupId":"OG001","value":"4.262","spread":"73.5"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4.567","spread":"77.5"}]}]}]},{"type":"SECONDARY","title":"Total Cholesterol","description":"Total cholesterol was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"mg/dL","timeFrame":"Week 26 and Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"191.2","spread":"17.6"},{"groupId":"OG001","value":"194.5","spread":"16.1"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"190.6","spread":"16.3"}]}]}]},{"type":"SECONDARY","title":"Low Density Lipoprotein (LDL) Cholesterol","description":"LDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"mg/dL","timeFrame":"Week 26 and Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"103.4","spread":"31.6"},{"groupId":"OG001","value":"107.1","spread":"27.8"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"104.5","spread":"26.2"}]}]}]},{"type":"SECONDARY","title":"High Density Lipoprotein (HDL) Cholesterol","description":"HDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"mg/dL","timeFrame":"Week 26 and Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"52.7","spread":"25.6"},{"groupId":"OG001","value":"52.9","spread":"26.3"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"53.3","spread":"24.7"}]}]}]},{"type":"SECONDARY","title":"Very Low Density Lipoprotein (VLDL) Cholesterol","description":"VLDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"mg/dL","timeFrame":"Week 26 and Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"26.8","spread":"56.7"},{"groupId":"OG001","value":"27.8","spread":"49.4"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"25.9","spread":"55.2"}]}]}]},{"type":"SECONDARY","title":"Triglycerides","description":"Triglycerides were evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"mg/dL","timeFrame":"Week 26 and Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"135.4","spread":"60.1"},{"groupId":"OG001","value":"142.3","spread":"54.9"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"130.4","spread":"57.0"}]}]}]},{"type":"SECONDARY","title":"Free Fatty Acids","description":"Free fatty acids were evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"mg/dL","timeFrame":"Week 26 and Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"12.56","spread":"47.4"},{"groupId":"OG001","value":"12.99","spread":"43.9"}]}]},{"title":"Week 52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"12.19","spread":"44.3"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment Emergent Adverse Events","description":"Treatment emergent adverse events (TEAEs) were evaluated during the 26-week and 52-week treatment period, respectively. TEAE for weeks 0-26: Event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 + 7 days). TEAE for weeks 0-52: Event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 52 + 7 days). Hence, the following shown 'Time Frame' should be read as 'Weeks 0-26 + 7 days and Weeks 0-52 + 7 days'.","populationDescription":"Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for weeks 0-52, as the subjects in this treatment arm received treatment for 26 weeks (main period).","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"Weeks 0-26 and Weeks 0-52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Weeks 0-26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"365"},{"groupId":"OG001","value":"266"}]}]},{"title":"Weeks 0-52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"588"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes","description":"Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were evaluated during the 26-week and 52-week treatment period, respectively. Severe or BG confirmed symptomatic hypoglycaemia (hypo):An episode that was severe according to the ADA classification or BG confirmed by a PG value \\<3.1 mmol/L with symptoms consistent with hypo. ADA definition of severe hypo:episode requiring assistance of another person to actively administer carbohydrate/glucagon, or take other corrective actions. PG levels may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG level. Treatment emergent: episode with onset date on or after randomisation (from week (wk) 0) and no later than 7 days after the last day on liraglutide (maximum till wk 26 and wk 52, respectively + 7 days). Hence, the following shown 'Time Frame' should be read as 'wk 0-26+7 days and wk 0-52+7 days'.","populationDescription":"Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for weeks 0-52, as the subjects in this treatment arm received treatment for 26 weeks (main period).","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"Weeks 0-26 and Weeks 0-52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Weeks 0-26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Weeks 0-52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes","description":"Treatment emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes were evaluated during the26-week and 52-week treatment period, respectively. Nocturnal hypoglycaemic episodes: Those occurring between 00:01 and 05:59 hours, both inclusive. Severe or BG confirmed symptomatic hypoglycaemia: episode that was severe according to the ADA classification or BG confirmed by a PG value \\<3.1 mmol/L with symptoms consistent with hypoglycaemia. Treatment emergent: episode with onset date on or after randomisation (from week 0) and no later than 7 days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Hence, the following shown 'Time Frame' should be read as 'Week 0-26 + 7 days and Week 0-52 + 7 days'.","populationDescription":"Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period).","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"Weeks 0-26 and Weeks 0-52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Weeks 0-26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Weeks 0-52","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition","description":"American Diabetes Association (ADA) classification of hypoglycaemia:\n\n1. Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level.\n2. Documented symptomatic: PG level ≤3.9 mmol/L with symptoms.\n3. Asymptomatic: PG level ≤3.9 mmol/L without symptoms.\n4. Probable symptomatic: No measurement with symptoms.\n5. Pseudo: PG level \\>3.9 mmol/L with symptoms. Treatment emergent hypoglycaemic episode: episode with onset date on or after randomisation (from week 0) and no later than 7 days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Hence, the following shown 'Time Frame' should be read as 'Week 0-26 + 7 days and Week 0-52 + 7 days'.","populationDescription":"Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period).","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"Weeks 0-26 and Weeks 0-52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Weeks 0-26: Severe hypoglycaemia","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Weeks 0-26: Documented symptomatic hypoglycaemia","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Weeks 0-26: Asymptomatic hypoglycaemia","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}]}]},{"title":"Weeks 0-26: Probable symptomatic hypoglycaemia","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"}]}]},{"title":"Weeks 0-26: Pseudo-hypoglycaemia","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}]}]},{"title":"Weeks 0-52: Severe hypoglycaemia","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"Weeks 0-52: Documented symptomatic hypoglycaemia","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"Weeks 0-52: Asymptomatic hypoglycaemia","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}]},{"title":"Weeks 0-52: Probable symptomatic hypoglycaemia","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}]},{"title":"Weeks 0-52: Pseudo-hypoglycaemia","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]}]},{"type":"SECONDARY","title":"Change in Pulse","description":"Change from baseline (week 0) in pulse was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Beats/minute","timeFrame":"Week 0, Week 26, Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 0: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"80.2","spread":"9.8"},{"groupId":"OG001","value":"80.8","spread":"10.4"}]}]},{"title":"Week 26: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.8","spread":"7.8"},{"groupId":"OG001","value":"0.2","spread":"7.9"}]}]},{"title":"Week 52: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.2","spread":"8.1"}]}]}]},{"type":"SECONDARY","title":"Change in Physical Examination","description":"Reported results are physical examination outcomes at week (wk) 0, wk 26 and wk 52. 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Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 0 and Week 26 and Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). 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After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 0: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"44.7","spread":"2.5"},{"groupId":"OG001","value":"45.1","spread":"2.2"}]}]},{"title":"Week 26: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.2","spread":"2.1"},{"groupId":"OG001","value":"-0.2","spread":"1.9"}]}]},{"title":"Week 52: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.2","spread":"2.2"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry: Total Bilirubin","description":"Change from baseline (week 0) in total bilirubin was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 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After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 0: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.52","spread":"0.29"},{"groupId":"OG001","value":"0.53","spread":"0.25"}]}]},{"title":"Week 26: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.04","spread":"0.25"},{"groupId":"OG001","value":"0.04","spread":"0.24"}]}]},{"title":"Week 52: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.06","spread":"0.23"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry: Urea","description":"Change from baseline (week 0) in urea was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 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After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 0: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"13.5","spread":"3.2"},{"groupId":"OG001","value":"14.0","spread":"3.7"}]}]},{"title":"Week 26: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.3","spread":"3.0"},{"groupId":"OG001","value":"-0.0","spread":"3.3"}]}]},{"title":"Week 52: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.7","spread":"2.8"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry: Creatine Kinase","description":"Change from baseline (week 0) in creatine kinase was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"U/L","timeFrame":"Week 0, Week 26, Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). 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'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg/dL","timeFrame":"Week 0, Week 26, Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 0: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"9.28","spread":"0.35"},{"groupId":"OG001","value":"9.26","spread":"0.32"}]}]},{"title":"Week 26: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.00","spread":"0.37"},{"groupId":"OG001","value":"0.02","spread":"0.35"}]}]},{"title":"Week 52: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.02","spread":"0.36"}]}]}]},{"type":"SECONDARY","title":"Change in Biochemistry: Amylase","description":"Change from baseline (week 0) in amylase was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 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After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 0: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"55.4","spread":"26.1"},{"groupId":"OG001","value":"57.3","spread":"28.7"}]}]},{"title":"Week 26: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.4","spread":"23.4"},{"groupId":"OG001","value":"-3.3","spread":"26.7"}]}]},{"title":"Week 52: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.0","spread":"22.0"}]}]}]},{"type":"SECONDARY","title":"Change in Haematology: Haemoglobin","description":"Change from baseline (week 0) in haemoglobin was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 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After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 0: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"14.65","spread":"1.26"},{"groupId":"OG001","value":"14.56","spread":"1.35"}]}]},{"title":"Week 26: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.00","spread":"0.67"},{"groupId":"OG001","value":"0.04","spread":"0.57"}]}]},{"title":"Week 52: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.00","spread":"0.76"}]}]}]},{"type":"SECONDARY","title":"Change in Haematology: Haematocrit","description":"Change from baseline (week 0) in haematocrit was evaluated after 26 weeks and 52 weeks of treatment, respectively. Haematocrit is the ratio of the volume of red blood cells to the total volume of blood.","populationDescription":"Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"% of red blood cell","timeFrame":"Week 0, Week 26, Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 0: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"44.86","spread":"3.79"},{"groupId":"OG001","value":"44.65","spread":"4.03"}]}]},{"title":"Week 26: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.22","spread":"2.26"},{"groupId":"OG001","value":"-0.06","spread":"1.90"}]}]},{"title":"Week 52: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.49","spread":"2.39"}]}]}]},{"type":"SECONDARY","title":"Change in Haematology: Thrombocytes","description":"Change from baseline (week 0) in thrombocytes (platelets) was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"10^9 cells/L","timeFrame":"Week 0, Week 26 and Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 0: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"229.1","spread":"47.4"},{"groupId":"OG001","value":"231.0","spread":"57.6"}]}]},{"title":"Week 26: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.8","spread":"27.4"},{"groupId":"OG001","value":"-1.5","spread":"24.2"}]}]},{"title":"Week 52: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3.4","spread":"24.9"}]}]}]},{"type":"SECONDARY","title":"Change in Haematology: Erythrocytes","description":"Change from baseline (week 0) in erythrocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"10^12 cells/L","timeFrame":"Week 0, Week 26 and Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 0: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4.87","spread":"0.41"},{"groupId":"OG001","value":"4.89","spread":"0.43"}]}]},{"title":"Week 26: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.02","spread":"0.24"},{"groupId":"OG001","value":"-0.00","spread":"0.20"}]}]},{"title":"Week 52: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.04","spread":"0.25"}]}]}]},{"type":"SECONDARY","title":"Change in Haematology: Leukocytes","description":"Change from baseline (week 0) in leukocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"10^9 cells/L","timeFrame":"Week 0, Week 26 and Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 0: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6.55","spread":"1.71"},{"groupId":"OG001","value":"6.53","spread":"1.58"}]}]},{"title":"Week 26: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.09","spread":"1.15"},{"groupId":"OG001","value":"-0.08","spread":"1.09"}]}]},{"title":"Week 52: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.09","spread":"1.44"}]}]}]},{"type":"SECONDARY","title":"Change in Haematology: Eosinophils","description":"Change from baseline (week 0) in eosinophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"10^9 cells/L","timeFrame":"Week 0, Week 26 and Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 0: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.182","spread":"0.143"},{"groupId":"OG001","value":"0.167","spread":"0.158"}]}]},{"title":"Week 26: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.001","spread":"0.118"},{"groupId":"OG001","value":"-0.016","spread":"0.104"}]}]},{"title":"Week 52: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.008","spread":"0.108"}]}]}]},{"type":"SECONDARY","title":"Change in Haematology: Neutrophils","description":"Change from baseline (week 0) in neutrophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"10^9 cells/L","timeFrame":"Week 0, Week 26 and Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 0: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3.967","spread":"1.337"},{"groupId":"OG001","value":"3.975","spread":"1.236"}]}]},{"title":"Week 26: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.054","spread":"1.029"},{"groupId":"OG001","value":"-0.088","spread":"0.941"}]}]},{"title":"Week 52: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.062","spread":"1.239"}]}]}]},{"type":"SECONDARY","title":"Change in Haematology: Basophils","description":"Change from baseline (week 0) in basophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"10^9 cells/L","timeFrame":"Week 0, Week 26 and Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 0: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.024","spread":"0.013"},{"groupId":"OG001","value":"0.026","spread":"0.013"}]}]},{"title":"Week 26: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.004","spread":"0.017"},{"groupId":"OG001","value":"0.000","spread":"0.016"}]}]},{"title":"Week 52: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.000","spread":"0.016"}]}]}]},{"type":"SECONDARY","title":"Change in Haematology: Monocytes","description":"Change from baseline (week 0) in monocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"10^9 cells/L","timeFrame":"Week 0, Week 26 and Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 0: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.341","spread":"0.133"},{"groupId":"OG001","value":"0.326","spread":"0.120"}]}]},{"title":"Week 26: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.001","spread":"0.101"},{"groupId":"OG001","value":"-0.000","spread":"0.104"}]}]},{"title":"Week 52: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.019","spread":"0.153"}]}]}]},{"type":"SECONDARY","title":"Change in Haematology: Lymphocytes","description":"Change from baseline (week 0) in lymphocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.","populationDescription":"Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"10^9 cells/L","timeFrame":"Week 0, Week 26 and Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 0: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.034","spread":"0.561"},{"groupId":"OG001","value":"2.037","spread":"0.583"}]}]},{"title":"Week 26: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.032","spread":"0.364"},{"groupId":"OG001","value":"0.022","spread":"0.389"}]}]},{"title":"Week 52: Change from baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.014","spread":"0.347"}]}]}]},{"type":"SECONDARY","title":"Change in Calcitonin","description":"Reported results are number of subjects with low, normal or high calcitonin values at week 0, week 26 and week 52. Number of subjects analyzed = number of subjects contributed to the analysis for individual time point. Calcitonin values were categorised as low, normal or high.","populationDescription":"Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 0 and Week 26 and Week 52","groups":[{"id":"OG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52."},{"id":"OG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"classes":[{"title":"Week 0: Low","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"232"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Week 0: Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"232"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"229"},{"groupId":"OG001","value":"229"}]}]},{"title":"Week 0: High","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"232"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"3"}]}]},{"title":"Week 26: Low","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Week 26: Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"228"},{"groupId":"OG001","value":"231"}]}]},{"title":"Week 26: High","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"233"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"2"}]}]},{"title":"Week 52: Low","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"Week 52: Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"230"}]}]},{"title":"Week 52: High","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"0"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).","description":"All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.","eventGroups":[{"id":"EG000","title":"Liraglutide 1.8 mg","description":"Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.","deathsNumAffected":0,"deathsNumAtRisk":233,"seriousNumAffected":8,"seriousNumAtRisk":233,"otherNumAffected":99,"otherNumAtRisk":233},{"id":"EG001","title":"Liraglutide 0.9 mg","description":"Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). 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