{"protocolSection":{"identificationModule":{"nctId":"NCT00700817","orgStudyIdInfo":{"id":"NN2211-1860"},"secondaryIdInfos":[{"id":"2007-003937-17","type":"EUDRACT_NUMBER"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus","officialTitle":"The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Subjects With Type 2 Diabetes. A 26-week, Randomised, Open-label, Active Comparator, Three-armed, Parallel-group, Multi-centre, Multinational Trial With a 52-week Extension"},"statusModule":{"statusVerifiedDate":"2017-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-06"},"primaryCompletionDateStruct":{"date":"2009-06","type":"ACTUAL"},"completionDateStruct":{"date":"2010-06","type":"ACTUAL"},"studyFirstSubmitDate":"2008-06-18","studyFirstSubmitQcDate":"2008-06-18","studyFirstPostDateStruct":{"date":"2008-06-19","type":"ESTIMATED"},"resultsFirstSubmitDate":"2010-06-11","resultsFirstSubmitQcDate":"2010-08-02","resultsFirstPostDateStruct":{"date":"2010-08-04","type":"ESTIMATED"},"lastUpdateSubmitDate":"2017-01-25","lastUpdatePostDateStruct":{"date":"2017-03-08","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This trial is conducted in Europe and North America. The aim of this trial is to compare the effect on blood sugar control of liraglutide or sitagliptin, both in combination with metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone.\n\nThe trial has been extended by 52 weeks. The extension will consist of two 26-week periods:\n\n1. Week 27-52 after randomisation\n\n   \\- All subjects will continue receiving sitagliptin or liraglutide at unchanged dose and dosing regimen.\n2. Week 53-78 after randomisation\n\n   * Subjects receiving sitagliptin at the end of week 52 after randomisation will discontinue sitagliptin and will be randomised 1:1 to liraglutide 1.2 mg/day or liraglutide 1.8 mg/day. Liraglutide will be initiated at a dose of 0.6 mg/day, and increased to 1.2 mg/day or 1.8 mg/day in weekly intervals.\n   * Subjects receiving liraglutide 1.2 mg/day or 1.8 mg/day at the end of week 52 after randomisation will continue the treatment at unchanged dose and dosing regimen. Trial completion is planned for June 2010."},"conditionsModule":{"conditions":["Diabetes","Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":665,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","type":"EXPERIMENTAL","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).","interventionNames":["Drug: liraglutide","Drug: metformin"]},{"label":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","type":"EXPERIMENTAL","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).","interventionNames":["Drug: metformin","Drug: liraglutide"]},{"label":"Sita -> Sita","type":"ACTIVE_COMPARATOR","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).","interventionNames":["Drug: sitagliptin","Drug: metformin"]},{"label":"Sita -> Sita -> Lira 1.2 mg","type":"EXPERIMENTAL","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.","interventionNames":["Drug: liraglutide","Drug: sitagliptin","Drug: metformin"]},{"label":"Sita -> Sita -> Lira 1.8 mg","type":"EXPERIMENTAL","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.","interventionNames":["Drug: sitagliptin","Drug: metformin","Drug: liraglutide"]}],"interventions":[{"type":"DRUG","name":"liraglutide","description":"1.2 mg once daily, subcutaneous (under the skin) injection","armGroupLabels":["Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","Sita -> Sita -> Lira 1.2 mg"]},{"type":"DRUG","name":"sitagliptin","description":"Tablets, 100 mg daily","armGroupLabels":["Sita -> Sita","Sita -> Sita -> Lira 1.2 mg","Sita -> Sita -> Lira 1.8 mg"]},{"type":"DRUG","name":"metformin","description":"Tablets, minimum 1500 mg daily","armGroupLabels":["Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","Sita -> Sita","Sita -> Sita -> Lira 1.2 mg","Sita -> Sita -> Lira 1.8 mg"]},{"type":"DRUG","name":"liraglutide","description":"1.8 mg once daily, subcutaneous (under the skin) injection","armGroupLabels":["Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","Sita -> Sita -> Lira 1.8 mg"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26","description":"Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.","timeFrame":"Week 0, Week 26"},{"measure":"Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52","description":"Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52.","timeFrame":"Week 0, Week 52"},{"measure":"Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78","description":"Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78.","timeFrame":"Week 0, Week 78"},{"measure":"Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78","description":"Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78","timeFrame":"Week 52, Week 78"}],"secondaryOutcomes":[{"measure":"Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26","description":"Calculated as the percentage of subjects achieving treatment target of HbA1c \\< 7.0% at Week 26","timeFrame":"Week 0, Week 26"},{"measure":"Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52","description":"Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \\< 7.0% at Week 52","timeFrame":"Week 0, Week 52"},{"measure":"Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78","description":"Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \\< 7.0% at Week 78. Based on the FAS.","timeFrame":"Week 0, Week 78"},{"measure":"Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78","description":"Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \\< 7.0% at Week 78. Based on the extension 2 FAS.","timeFrame":"Week 0, Week 78"},{"measure":"Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26","description":"Calculated as the percentage of subjects achieving treatment target of HbA1c =\\< 6.5% at Week 26","timeFrame":"Week 0, Week 26"},{"measure":"Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52","description":"Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\\< 6.5% at Week 52","timeFrame":"Week 0, Week 52"},{"measure":"Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78","description":"Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\\< 6.5% at Week 78. Based on the FAS.","timeFrame":"Week 0, Week 78"},{"measure":"Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78","description":"Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\\< 6.5% at Week 78. Based on the extension 2 FAS.","timeFrame":"Week 0, Week 78"},{"measure":"Mean Change From Baseline in Body Weight at Week 26","description":"Calculated as an estimate of the mean change from baseline in body weight at Week 26.","timeFrame":"Week 0, Week 26"},{"measure":"Mean Change From Baseline in Body Weight at Week 52","description":"Calculated as an estimate of the mean change from baseline in body weight at Week 52.","timeFrame":"Week 0, Week 52"},{"measure":"Mean Change in Body Weight From Week 52 to Week 78","description":"Mean change in body weight from Week 52 to Week 78.","timeFrame":"Week 52, Week 78"},{"measure":"Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26","description":"Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26.","timeFrame":"Week 0, Week 26"},{"measure":"Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52","description":"Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52.","timeFrame":"Week 0, Week 52"},{"measure":"Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78","description":"Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78.","timeFrame":"Week 0, Week 78"},{"measure":"Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78","description":"Mean change in fasting plasma glucose (FPG) Week 52 to Week 78.","timeFrame":"Week 52, Week 78"},{"measure":"Mean Change From Baseline in Beta-cell Function at Week 26","description":"Calculated as an estimate of the mean change from baseline in beta-cell function at Week 26.\n\nDerived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).","timeFrame":"Week 0, Week 26"},{"measure":"Mean Change From Baseline in Beta-cell Function at Week 52","description":"Calculated as an estimate of the mean change from baseline in beta-cell function at Week 52.\n\nDerived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).","timeFrame":"Week 0, Week 52"},{"measure":"Mean Change in Beta-cell Function From Week 52 to Week 78","description":"Mean change in beta-cell function from Week 52 to Week 78. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).","timeFrame":"Week 52, Week 78"},{"measure":"Mean Change From Baseline in Total Cholesterol at Week 26","description":"Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26.","timeFrame":"Week 0, Week 26"},{"measure":"Mean Change From Baseline in Total Cholesterol at Week 52","description":"Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52.","timeFrame":"Week 0, Week 52"},{"measure":"Mean Change in Total Cholesterol From Week 52 to Week 78","description":"Mean change in total cholesterol from Week 52 to Week 78","timeFrame":"Week 52, Week 78"},{"measure":"Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26","description":"Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26.","timeFrame":"Week 0, Week 26"},{"measure":"Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52","description":"Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52.","timeFrame":"Week 0, Week 52"},{"measure":"Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78","description":"Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78.","timeFrame":"Week 52, Week 78"},{"measure":"Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26","description":"Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26.","timeFrame":"Week 0, Week 26"},{"measure":"Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52","description":"Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52.","timeFrame":"Week 0, Week 52"},{"measure":"Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78","description":"Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78.","timeFrame":"Week 52, Week 78"},{"measure":"Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26","description":"Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26.","timeFrame":"Week 0, Week 26"},{"measure":"Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52","description":"Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52.","timeFrame":"Week 0, Week 52"},{"measure":"Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78","description":"Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78.","timeFrame":"Week 52, Week 78"},{"measure":"Mean Change From Baseline in Triglycerides (TG) at Week 26","description":"Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26.","timeFrame":"Week 0, Week 26"},{"measure":"Mean Change From Baseline in Triglycerides (TG) at Week 52","description":"Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52.","timeFrame":"Week 0, Week 52"},{"measure":"Mean Change in Triglycerides (TG) From Week 52 to Week 78","description":"Mean change in triglycerides (TG) from Week 52 to Week 78.","timeFrame":"Week 52, Week 78"},{"measure":"Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26","description":"Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26.","timeFrame":"Week 0, Week 26"},{"measure":"Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52","description":"Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52.","timeFrame":"Week 0, Week 52"},{"measure":"Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78","description":"Mean change in free fatty acids (FFA) from Week 52 to Week 78.","timeFrame":"Week 52, Week 78"},{"measure":"Mean Change From Baseline in Apolipoprotein B at Week 26","description":"Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26.","timeFrame":"Week 0, Week 26"},{"measure":"Mean Change From Baseline in Apolipoprotein B at Week 52","description":"Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52.","timeFrame":"Week 0, Week 52"},{"measure":"Mean Change in Apolipoprotein B From Week 52 to Week 78","description":"Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78.","timeFrame":"Week 52, Week 78"},{"measure":"Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26","description":"Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26.","timeFrame":"Week 0, Week 26"},{"measure":"Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26.","description":"Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26.","timeFrame":"Week 0, Week 26"},{"measure":"Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26.","description":"Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26.","timeFrame":"Week 0, Week 26"},{"measure":"Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.","description":"Calculated as an estimate of the mean change from baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.","timeFrame":"Week 0, Week 26"},{"measure":"Mean Change From Baseline in Adiponectin at Week 26.","description":"Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26.","timeFrame":"Week 0, Week 26"},{"measure":"Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.","description":"Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.","timeFrame":"Week 0, Week 26"},{"measure":"Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26.","description":"Calculated as an estimate of the mean change from baseline in von Willebrand Factor (vWf) at Week 26. vWf is a blood glycoprotein involved in haemostasis.","timeFrame":"Week 0, Week 26"},{"measure":"Mean Change From Baseline in Waist to Hip Ratio at Week 26.","description":"Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 26. The measure is assessed as the circumference of the waist divided by the circumference of the hip.","timeFrame":"Week 0, Week 26"},{"measure":"Mean Change From Baseline in Waist to Hip Ratio at Week 52","description":"Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 52. The measure is assessed as the circumference of the waist divided by the circumference of the hip.","timeFrame":"Week 0, Week 52"},{"measure":"Mean Change in Waist to Hip Ratio From Week 52 to Week 78","description":"Mean change in Waist to Hip Ratio from Week 52 to Week 78. The measure is assessed as the circumference of the waist divided by the circumference of the hip.","timeFrame":"Week 52, Week 78"},{"measure":"Mean Change From Baseline in Waist Circumference at Week 26.","description":"Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26","timeFrame":"Week 0, Week 26"},{"measure":"Mean Change From Baseline in Waist Circumference at Week 52","description":"Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52.","timeFrame":"Week 0, Week 52"},{"measure":"Mean Change in Waist Circumference From Week 52 to Week 78","description":"Mean change in Waist Circumference from Week 52 to Week 78.","timeFrame":"Week 52, Week 78"},{"measure":"Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26","description":"Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26","timeFrame":"Week 0, Week 26"},{"measure":"Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52","description":"Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52.","timeFrame":"Week 0, Week 52"},{"measure":"Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78","description":"Mean change in systolic blood pressure (SBP) from Week 52 to Week 78.","timeFrame":"Week 52, Week 78"},{"measure":"Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26","description":"Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26.","timeFrame":"Week 0, Week 26"},{"measure":"Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52","description":"Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52.","timeFrame":"Week 0, Week 52"},{"measure":"Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78","description":"Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78.","timeFrame":"Week 52, Week 78"},{"measure":"Mean Change From Baseline in Pulse at Week 26","description":"Calculated as an estimate of the mean change from baseline in pulse at Week 26.","timeFrame":"Week 0, Week 26"},{"measure":"Mean Change From Baseline in Pulse at Week 52","description":"Calculated as an estimate of the mean change from baseline in pulse at Week 52.","timeFrame":"Week 0, Week 52"},{"measure":"Mean Change in Pulse From Week 52 to Week 78","description":"Mean change in pulse from Week 52 to Week 78.","timeFrame":"Week 52, Week 78"},{"measure":"Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26","description":"The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.","timeFrame":"Week 0, Week 26"},{"measure":"Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52","description":"The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.","timeFrame":"Week 0, Week 52"},{"measure":"Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78","description":"The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.","timeFrame":"Week 52, Week 78"},{"measure":"Hypoglyceamic Episodes, Weeks 0-26","description":"Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.","timeFrame":"Weeks 0-26"},{"measure":"Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26","description":"Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.","timeFrame":"Weeks 0-26"},{"measure":"Hypoglyceamic Episodes, Weeks 0-52","description":"Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.","timeFrame":"Weeks 0-52"},{"measure":"Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52","description":"Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.","timeFrame":"Weeks 0-52"},{"measure":"Hypoglyceamic Episodes, Weeks 0-78","description":"Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.","timeFrame":"Weeks 0-78"},{"measure":"Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78","description":"Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.","timeFrame":"Weeks 0-78"},{"measure":"Hypoglycaamic Episodes, Weeks 52-78","description":"Number of hypoglycaemic episodes from Week 52 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.","timeFrame":"Week 52-78"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Type 2 diabetes\n* Treatment with metformin alone for at least three months\n* HbA1c (glycosylated haemoglobin A1c) 7.5-10.0% (both inclusive)\n* Body Mass Index (BMI) less than or equal to 45.0\n\nExclusion Criteria:\n\n* Previous treatment with insulin, glucagon like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase-4 (DPP-4) inhibitors\n* Treatment with anti-diabetic drugs other than metformin within the last three months\n* Any serious medical condition\n* Females who are pregnant, have the intention of becoming pregnant or are breastfeeding","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"80 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Global Clinical Registry (GCR, 1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Novo Nordisk Investigational Site","city":"Birmingham","state":"Alabama","zip":"35242","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"Novo Nordisk Investigational Site","city":"Escondido","state":"California","zip":"92025","country":"United States","geoPoint":{"lat":33.11921,"lon":-117.08642}},{"facility":"Novo Nordisk Investigational Site","city":"Fresno","state":"California","zip":"93720","country":"United States","geoPoint":{"lat":36.74773,"lon":-119.77237}},{"facility":"Novo Nordisk Investigational Site","city":"Huntington Beach","state":"California","zip":"92646","country":"United States","geoPoint":{"lat":33.6603,"lon":-117.99923}},{"facility":"Novo Nordisk Investigational Site","city":"Long Beach","state":"California","zip":"90822","country":"United States","geoPoint":{"lat":33.76696,"lon":-118.18923}},{"facility":"Novo Nordisk Investigational Site","city":"Northridge","state":"California","zip":"91325","country":"United States","geoPoint":{"lat":34.22834,"lon":-118.53675}},{"facility":"Novo Nordisk Investigational Site","city":"Orange","state":"California","zip":"92869","country":"United States","geoPoint":{"lat":33.78779,"lon":-117.85311}},{"facility":"Novo Nordisk Investigational Site","city":"Poway","state":"California","zip":"92064","country":"United States","geoPoint":{"lat":32.96282,"lon":-117.03586}},{"facility":"Novo Nordisk Investigational Site","city":"Walnut Creek","state":"California","zip":"94598","country":"United States","geoPoint":{"lat":37.90631,"lon":-122.06496}},{"facility":"Novo Nordisk Investigational Site","city":"Denver","state":"Colorado","zip":"80209","country":"United States","geoPoint":{"lat":39.73915,"lon":-104.9847}},{"facility":"Novo Nordisk Investigational Site","city":"Crystal River","state":"Florida","zip":"34429","country":"United 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Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallel-group, open-label trial. Lancet. 2010 Apr 24;375(9724):1447-56. doi: 10.1016/S0140-6736(10)60307-8."},{"pmid":"21309842","type":"RESULT","citation":"Davies M, Pratley R, Hammer M, Thomsen AB, Cuddihy R. Liraglutide improves treatment satisfaction in people with Type 2 diabetes compared with sitagliptin, each as an add on to metformin. Diabet Med. 2011 Mar;28(3):333-7. doi: 10.1111/j.1464-5491.2010.03074.x."},{"pmid":"21355967","type":"RESULT","citation":"Pratley R, Nauck M, Bailey T, Montanya E, Cuddihy R, Filetti S, Garber A, Thomsen AB, Hartvig H, Davies M; 1860-LIRA-DPP-4 Study Group. One year of liraglutide treatment offers sustained and more effective glycaemic control and weight reduction compared with sitagliptin, both in combination with metformin, in patients with type 2 diabetes: a randomised, parallel-group, open-label trial. Int J Clin Pract. 2011 Apr;65(4):397-407. doi: 10.1111/j.1742-1241.2011.02656.x. Epub 2011 Mar 1."},{"pmid":"22193143","type":"RESULT","citation":"Henry RR, Buse JB, Sesti G, Davies MJ, Jensen KH, Brett J, Pratley RE. Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program. Endocr Pract. 2011 Nov-Dec;17(6):906-13. doi: 10.4158/ep.17.6.906."},{"pmid":"21883806","type":"RESULT","citation":"Zinman B, Schmidt WE, Moses A, Lund N, Gough S. Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme. Diabetes Obes Metab. 2012 Jan;14(1):77-82. doi: 10.1111/j.1463-1326.2011.01493.x. Epub 2011 Oct 30."},{"pmid":"21883438","type":"RESULT","citation":"Davies MJ, Chubb BD, Smith IC, Valentine WJ. Cost-utility analysis of liraglutide compared with sulphonylurea or sitagliptin, all as add-on to metformin monotherapy in Type 2 diabetes mellitus. Diabet Med. 2012 Mar;29(3):313-20. doi: 10.1111/j.1464-5491.2011.03429.x."},{"pmid":"22851600","type":"RESULT","citation":"Pratley RE, Nauck MA, Bailey T, Montanya E, Filetti S, Garber AJ, Thomsen AB, Furber S, Davies M; 1860-LIRA-DPP-4 Study Group. Efficacy and safety of switching from the DPP-4 inhibitor sitagliptin to the human GLP-1 analog liraglutide after 52 weeks in metformin-treated patients with type 2 diabetes: a randomized, open-label trial. Diabetes Care. 2012 Oct;35(10):1986-93. doi: 10.2337/dc11-2113. Epub 2012 Jul 30."},{"pmid":"22834986","type":"RESULT","citation":"Lee WC, Samyshkin Y, Langer J, Palmer JL. Long-term clinical and economic outcomes associated with liraglutide versus sitagliptin therapy when added to metformin in the treatment of type 2 diabetes: a CORE Diabetes Model analysis. J Med Econ. 2012;15 Suppl 2:28-37. doi: 10.3111/13696998.2012.716111. Epub 2012 Aug 13."},{"pmid":"22862847","type":"RESULT","citation":"Niswender K, Pi-Sunyer X, Buse J, Jensen KH, Toft AD, Russell-Jones D, Zinman B. Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme. Diabetes Obes Metab. 2013 Jan;15(1):42-54. doi: 10.1111/j.1463-1326.2012.01673.x. Epub 2012 Sep 9."},{"pmid":"23010561","type":"RESULT","citation":"Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23."},{"pmid":"23186975","type":"RESULT","citation":"King AB, Montanya E, Pratley RE, Blonde L, Svendsen CB, Donsmark M, Sesti G. Liraglutide achieves A1C targets more often than sitagliptin or exenatide when added to metformin in patients with type 2 diabetes and a baseline A1C <8.0%. Endocr Pract. 2013 Jan-Feb;19(1):64-72. doi: 10.4158/EP12232.OR."},{"pmid":"25504028","type":"RESULT","citation":"Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12."},{"pmid":"26936426","type":"RESULT","citation":"Davidson JA, Orsted DD, Campos C. Efficacy and safety of liraglutide, a once-daily human glucagon-like peptide-1 analogue, in Latino/Hispanic patients with type 2 diabetes: post hoc analysis of data from four phase III trials. Diabetes Obes Metab. 2016 Jul;18(7):725-8. doi: 10.1111/dom.12653. Epub 2016 Apr 28."},{"pmid":"23537458","type":"DERIVED","citation":"Langer J, Hunt B, Valentine WJ. Evaluating the short-term cost-effectiveness of liraglutide versus sitagliptin in patients with type 2 diabetes failing metformin monotherapy in the United States. J Manag Care Pharm. 2013 Apr;19(3):237-46. doi: 10.18553/jmcp.2013.19.3.237."}],"seeAlsoLinks":[{"label":"Clinical Trials at Novo Nordisk","url":"http://novonordisk-trials.com"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Between screening and randomisation, eligible subjects were to continue their usual pre-study metformin dose and dosing frequency.","recruitmentDetails":"A total of 158 centres in 13 countries participated: Canada (11), Croatia (3), Germany (12), Ireland (5), Italy (8), Netherlands (8), Romania (4), Serbia (3), Slovakia (6), Slovenia (3), Spain (9), United Kingdom (20) and United States (66). Of the 158 sites approved by an Independent Ethics Committee, 151 actively screened and enrolled subjects.","groups":[{"id":"FG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"FG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. 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Some subjects withdrew before entry to extension period 2.","numSubjects":"67"},{"groupId":"FG004","comment":"Re-randomised from sita treatment group. Some subjects withdrew before entry to extension period 2.","numSubjects":"68"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"124"},{"groupId":"FG001","numSubjects":"135"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"59"},{"groupId":"FG004","numSubjects":"63"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"15"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"8"},{"groupId":"FG004","numSubjects":"5"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"6"},{"groupId":"FG004","numSubjects":"0"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"1"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]},{"type":"Withdrawal criteria","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"3"}]},{"type":"Unclassified","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"BG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"BG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"BG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"BG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."},{"id":"BG005","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"225"},{"groupId":"BG001","value":"221"},{"groupId":"BG002","value":"219"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"665"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"55.9","spread":"9.6"},{"groupId":"BG001","value":"55.0","spread":"9.1"},{"groupId":"BG002","value":"55.0","spread":"9.0"},{"groupId":"BG005","value":"55.3","spread":"9.2"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"109"},{"groupId":"BG001","value":"105"},{"groupId":"BG002","value":"99"},{"groupId":"BG005","value":"313"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"116"},{"groupId":"BG001","value":"116"},{"groupId":"BG002","value":"120"},{"groupId":"BG005","value":"352"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"39"},{"groupId":"BG001","value":"34"},{"groupId":"BG002","value":"35"},{"groupId":"BG005","value":"108"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"186"},{"groupId":"BG001","value":"187"},{"groupId":"BG002","value":"184"},{"groupId":"BG005","value":"557"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG005","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG005","value":"3"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"1"},{"groupId":"BG005","value":"11"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG005","value":"2"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"22"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"10"},{"groupId":"BG005","value":"48"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"184"},{"groupId":"BG001","value":"193"},{"groupId":"BG002","value":"199"},{"groupId":"BG005","value":"576"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG005","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"8"},{"groupId":"BG005","value":"25"}]}]}]},{"title":"Body Mass Index (BMI) at Screening","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg/m^2","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"32.6","spread":"5.2"},{"groupId":"BG001","value":"33.1","spread":"5.1"},{"groupId":"BG002","value":"32.6","spread":"5.4"},{"groupId":"BG005","value":"32.8","spread":"5.2"}]}]}]},{"title":"Duration of Diabetes","description":"The time (in years) the patient had been diagnosed with diabetes when screened for the trial","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6.0","spread":"4.5"},{"groupId":"BG001","value":"6.4","spread":"5.4"},{"groupId":"BG002","value":"6.3","spread":"5.4"},{"groupId":"BG005","value":"6.2","spread":"5.1"}]}]}]},{"title":"Fasting Plasma Glucose (FPG) at Randomisation","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmol/L","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"10.1","spread":"2.4"},{"groupId":"BG001","value":"9.9","spread":"2.4"},{"groupId":"BG002","value":"10.0","spread":"2.0"},{"groupId":"BG005","value":"10.0","spread":"2.3"}]}]}]},{"title":"Glycosylated Haemoglobin A1c (HbA1c) at Randomisation","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Percentage point of total HbA1c","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.4","spread":"0.8"},{"groupId":"BG001","value":"8.4","spread":"0.7"},{"groupId":"BG002","value":"8.5","spread":"0.7"},{"groupId":"BG005","value":"8.4","spread":"0.8"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26","description":"Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percentage point of total HbA1c","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"211"},{"groupId":"OG001","value":"214"},{"groupId":"OG002","value":"210"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.24","spread":"0.07"},{"groupId":"OG001","value":"-1.5","spread":"0.06"},{"groupId":"OG002","value":"-0.9","spread":"0.07"}]}]}],"analyses":[{"groupIds":["OG001","OG002"],"groupDescription":"ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate. Hieracheal testing of non-inferiority followed by superiority.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.","pValue":"0.0001","pValueComment":"Multiple comparisons not applicable due to the hieracheal testing.","statisticalMethod":"ANCOVA","statisticalComment":"Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).","paramType":"Estimated treatment difference, LS Mean","paramValue":"-0.6","ciPctValue":"95","ciLowerLimit":"-0.77","ciUpperLimit":"-0.43"},{"groupIds":["OG000","OG002"],"groupDescription":"ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate. Hieracheal testing of non-inferiority followed by superiority. Liraglutide 1.2 mg versus sitagliptin only tested if liraglutide 1.8 mg was superior to sitagliptin.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.","pValue":"0.0001","pValueComment":"Multiple comparisons not applicable due to the hieracheal testing.","statisticalMethod":"ANCOVA","statisticalComment":"Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).","paramType":"Estimated treatment difference, LS Mean","paramValue":"-0.34","ciPctValue":"95","ciLowerLimit":"-0.51","ciUpperLimit":"-0.16"}]},{"type":"PRIMARY","title":"Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52","description":"Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percentage point of total HbA1c","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"211"},{"groupId":"OG001","value":"214"},{"groupId":"OG002","value":"210"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.29","spread":"0.07"},{"groupId":"OG001","value":"-1.51","spread":"0.07"},{"groupId":"OG002","value":"-0.88","spread":"0.07"}]}]}],"analyses":[{"groupIds":["OG001","OG002"],"groupDescription":"ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.","pValue":"0.0001","pValueComment":"Multiple comparisons not applicable due to the hieracheal testing.","statisticalMethod":"ANCOVA","statisticalComment":"Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).","paramType":"Estimated Treatment Difference, LS Mean","paramValue":"-0.63","ciPctValue":"95","ciLowerLimit":"-0.81","ciUpperLimit":"-0.44","estimateComment":"Lira 1.8 - Sita"},{"groupIds":["OG000","OG002"],"groupDescription":"ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.","pValue":"0.0001","pValueComment":"Multiple comparisons not applicable due to the hieracheal testing.","statisticalMethod":"ANCOVA","statisticalComment":"Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).","paramType":"Estimated Treatment Difference, LS Mean","paramValue":"-0.40","ciPctValue":"95","ciLowerLimit":"-0.59","ciUpperLimit":"-0.22","estimateComment":"Lira 1.2 - Sita"}]},{"type":"PRIMARY","title":"Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78","description":"Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percentage point of total HbA1c","timeFrame":"Week 0, Week 78","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"211"},{"groupId":"OG001","value":"214"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.94","spread":"0.08"},{"groupId":"OG001","value":"-1.28","spread":"0.07"}]}]}]},{"type":"PRIMARY","title":"Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78","description":"Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78","populationDescription":"Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage point of total HbA1c","timeFrame":"Week 52, Week 78","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"67"},{"groupId":"OG004","value":"68"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG003","value":"-0.24","spread":"0.7"},{"groupId":"OG004","value":"-0.45","spread":"0.9"}]}]}],"analyses":[{"groupIds":["OG003"],"groupDescription":"The t-test was performed to examine whether the change in HbA1c from week 52 to week 78 were different from 0 within each treatment group.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0060","pValueComment":"Multiple comparisons is not applicable.","statisticalMethod":"paired t-test","statisticalComment":"The analysis is not a controlled comparison, and there are no adjustments","paramType":"Change within treatment group","paramValue":"-0.24","ciPctValue":"95","ciLowerLimit":"-0.41","ciUpperLimit":"-0.07","dispersionType":"STANDARD_DEVIATION","dispersionValue":"0.7"},{"groupIds":["OG004"],"groupDescription":"The t-test was performed to examine whether the change in HbA1c from week 52 to week 78 were different from 0 within each treatment group.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0001","pValueComment":"Multiple comparisons is not applicable.","statisticalMethod":"paired t-test","statisticalComment":"The analysis is not a controlled comparison, and there are no adjustments","paramType":"Change within treatment group","paramValue":"-0.45","ciPctValue":"95","ciLowerLimit":"-0.67","ciUpperLimit":"-0.23","dispersionType":"STANDARD_DEVIATION","dispersionValue":"0.9"}]},{"type":"SECONDARY","title":"Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26","description":"Calculated as the percentage of subjects achieving treatment target of HbA1c \\< 7.0% at Week 26","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"221"},{"groupId":"OG001","value":"218"},{"groupId":"OG002","value":"219"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"55"},{"groupId":"OG002","value":"22"}]}]}]},{"type":"SECONDARY","title":"Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52","description":"Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \\< 7.0% at Week 52","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"211"},{"groupId":"OG001","value":"214"},{"groupId":"OG002","value":"210"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"27"}]}]}]},{"type":"SECONDARY","title":"Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78","description":"Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \\< 7.0% at Week 78. Based on the FAS.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"Week 0, Week 78","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"211"},{"groupId":"OG001","value":"214"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"51"}]}]}]},{"type":"SECONDARY","title":"Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78","description":"Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \\< 7.0% at Week 78. Based on the extension 2 FAS.","populationDescription":"Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"Week 0, Week 78","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"67"},{"groupId":"OG004","value":"68"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG003","value":"49"},{"groupId":"OG004","value":"50"}]}]}]},{"type":"SECONDARY","title":"Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26","description":"Calculated as the percentage of subjects achieving treatment target of HbA1c =\\< 6.5% at Week 26","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"221"},{"groupId":"OG001","value":"218"},{"groupId":"OG002","value":"219"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"36"},{"groupId":"OG002","value":"12"}]}]}]},{"type":"SECONDARY","title":"Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52","description":"Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\\< 6.5% at Week 52","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"211"},{"groupId":"OG001","value":"214"},{"groupId":"OG002","value":"210"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"17"}]}]}]},{"type":"SECONDARY","title":"Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78","description":"Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\\< 6.5% at Week 78. Based on the FAS.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"Week 0, Week 78","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"211"},{"groupId":"OG001","value":"214"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"27"}]}]}]},{"type":"SECONDARY","title":"Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78","description":"Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\\< 6.5% at Week 78. Based on the extension 2 FAS.","populationDescription":"Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects","timeFrame":"Week 0, Week 78","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"67"},{"groupId":"OG004","value":"68"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG003","value":"29"},{"groupId":"OG004","value":"25"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Body Weight at Week 26","description":"Calculated as an estimate of the mean change from baseline in body weight at Week 26.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kg","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"215"},{"groupId":"OG001","value":"214"},{"groupId":"OG002","value":"215"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.86","spread":"0.27"},{"groupId":"OG001","value":"-3.38","spread":"0.27"},{"groupId":"OG002","value":"-0.96","spread":"0.27"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Body Weight at Week 52","description":"Calculated as an estimate of the mean change from baseline in body weight at Week 52.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kg","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"215"},{"groupId":"OG001","value":"214"},{"groupId":"OG002","value":"215"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.78","spread":"0.31"},{"groupId":"OG001","value":"-3.68","spread":"0.31"},{"groupId":"OG002","value":"-1.16","spread":"0.31"}]}]}]},{"type":"SECONDARY","title":"Mean Change in Body Weight From Week 52 to Week 78","description":"Mean change in body weight from Week 52 to Week 78.","populationDescription":"Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kg","timeFrame":"Week 52, Week 78","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"67"},{"groupId":"OG004","value":"68"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG003","value":"-1.64","spread":"3"},{"groupId":"OG004","value":"-2.48","spread":"3.6"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26","description":"Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"210"},{"groupId":"OG001","value":"212"},{"groupId":"OG002","value":"210"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.87","spread":"0.15"},{"groupId":"OG001","value":"-2.14","spread":"0.15"},{"groupId":"OG002","value":"-0.83","spread":"0.15"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52","description":"Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"210"},{"groupId":"OG001","value":"212"},{"groupId":"OG002","value":"209"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.71","spread":"0.17"},{"groupId":"OG001","value":"-2.04","spread":"0.17"},{"groupId":"OG002","value":"-0.59","spread":"0.17"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78","description":"Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Week 0, Week 78","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"210"},{"groupId":"OG001","value":"212"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.30","spread":"0.18"},{"groupId":"OG001","value":"-1.65","spread":"0.18"}]}]}]},{"type":"SECONDARY","title":"Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78","description":"Mean change in fasting plasma glucose (FPG) Week 52 to Week 78.","populationDescription":"Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 52, Week 78","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"65"},{"groupId":"OG004","value":"67"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG003","value":"-0.84","spread":"1.8"},{"groupId":"OG004","value":"-1.42","spread":"2.1"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Beta-cell Function at Week 26","description":"Calculated as an estimate of the mean change from baseline in beta-cell function at Week 26.\n\nDerived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage point","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"196"},{"groupId":"OG001","value":"208"},{"groupId":"OG002","value":"201"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"27.23","spread":"3.82"},{"groupId":"OG001","value":"28.70","spread":"3.75"},{"groupId":"OG002","value":"4.18","spread":"3.79"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Beta-cell Function at Week 52","description":"Calculated as an estimate of the mean change from baseline in beta-cell function at Week 52.\n\nDerived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage point","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"196"},{"groupId":"OG001","value":"208"},{"groupId":"OG002","value":"200"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"22.58","spread":"3.31"},{"groupId":"OG001","value":"25.76","spread":"3.25"},{"groupId":"OG002","value":"3.98","spread":"3.30"}]}]}]},{"type":"SECONDARY","title":"Mean Change in Beta-cell Function From Week 52 to Week 78","description":"Mean change in beta-cell function from Week 52 to Week 78. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).","populationDescription":"Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage point","timeFrame":"Week 52, Week 78","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"64"},{"groupId":"OG004","value":"64"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG003","value":"13.31","spread":"29.4"},{"groupId":"OG004","value":"23.09","spread":"43.7"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Total Cholesterol at Week 26","description":"Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"194"},{"groupId":"OG001","value":"202"},{"groupId":"OG002","value":"201"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.03","spread":"0.06"},{"groupId":"OG001","value":"-0.17","spread":"0.05"},{"groupId":"OG002","value":"-0.02","spread":"0.05"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Total Cholesterol at Week 52","description":"Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"195"},{"groupId":"OG001","value":"203"},{"groupId":"OG002","value":"200"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.01","spread":"0.06"},{"groupId":"OG001","value":"-0.09","spread":"0.06"},{"groupId":"OG002","value":"0.03","spread":"0.06"}]}]}]},{"type":"SECONDARY","title":"Mean Change in Total Cholesterol From Week 52 to Week 78","description":"Mean change in total cholesterol from Week 52 to Week 78","populationDescription":"Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 52, Week 78","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"65"},{"groupId":"OG004","value":"67"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG003","value":"-0.16","spread":"0.8"},{"groupId":"OG004","value":"-0.24","spread":"0.7"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26","description":"Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"194"},{"groupId":"OG001","value":"202"},{"groupId":"OG002","value":"200"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.08","spread":"0.05"},{"groupId":"OG001","value":"0.05","spread":"0.05"},{"groupId":"OG002","value":"0.13","spread":"0.05"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52","description":"Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"195"},{"groupId":"OG001","value":"203"},{"groupId":"OG002","value":"199"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.09","spread":"0.05"},{"groupId":"OG001","value":"0.09","spread":"0.05"},{"groupId":"OG002","value":"0.17","spread":"0.05"}]}]}]},{"type":"SECONDARY","title":"Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78","description":"Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78.","populationDescription":"Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 52, Week 78","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"65"},{"groupId":"OG004","value":"67"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG003","value":"-0.22","spread":"0.7"},{"groupId":"OG004","value":"-0.25","spread":"0.6"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26","description":"Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"194"},{"groupId":"OG001","value":"201"},{"groupId":"OG002","value":"201"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.00","spread":"0.01"},{"groupId":"OG001","value":"0.00","spread":"0.01"},{"groupId":"OG002","value":"0.00","spread":"0.01"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52","description":"Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"195"},{"groupId":"OG001","value":"202"},{"groupId":"OG002","value":"200"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.01","spread":"0.01"},{"groupId":"OG001","value":"0.02","spread":"0.01"},{"groupId":"OG002","value":"0.01","spread":"0.01"}]}]}]},{"type":"SECONDARY","title":"Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78","description":"Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78.","populationDescription":"Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 52, Week 78","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"65"},{"groupId":"OG004","value":"67"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG003","value":"0.02","spread":"0.1"},{"groupId":"OG004","value":"-0.01","spread":"0.2"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26","description":"Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"194"},{"groupId":"OG001","value":"201"},{"groupId":"OG002","value":"199"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.11","spread":"0.03"},{"groupId":"OG001","value":"-0.20","spread":"0.03"},{"groupId":"OG002","value":"-0.15","spread":"0.03"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52","description":"Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"195"},{"groupId":"OG001","value":"202"},{"groupId":"OG002","value":"198"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.11","spread":"0.04"},{"groupId":"OG001","value":"-0.19","spread":"0.04"},{"groupId":"OG002","value":"-0.15","spread":"0.04"}]}]}]},{"type":"SECONDARY","title":"Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78","description":"Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78.","populationDescription":"Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 52, Week 78","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"65"},{"groupId":"OG004","value":"67"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG003","value":"0.03","spread":"0.3"},{"groupId":"OG004","value":"0.02","spread":"0.3"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Triglycerides (TG) at Week 26","description":"Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"191"},{"groupId":"OG001","value":"199"},{"groupId":"OG002","value":"198"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.19","spread":"0.10"},{"groupId":"OG001","value":"-0.43","spread":"0.09"},{"groupId":"OG002","value":"-0.40","spread":"0.09"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Triglycerides (TG) at Week 52","description":"Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"194"},{"groupId":"OG001","value":"200"},{"groupId":"OG002","value":"197"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.10","spread":"0.10"},{"groupId":"OG001","value":"-0.32","spread":"0.10"},{"groupId":"OG002","value":"-0.23","spread":"0.10"}]}]}]},{"type":"SECONDARY","title":"Mean Change in Triglycerides (TG) From Week 52 to Week 78","description":"Mean change in triglycerides (TG) from Week 52 to Week 78.","populationDescription":"Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 52, Week 78","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"64"},{"groupId":"OG004","value":"66"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG003","value":"-0.20","spread":"0.8"},{"groupId":"OG004","value":"-0.26","spread":"0.8"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26","description":"Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"147"},{"groupId":"OG001","value":"149"},{"groupId":"OG002","value":"158"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.03","spread":"0.02"},{"groupId":"OG001","value":"-0.07","spread":"0.02"},{"groupId":"OG002","value":"-0.05","spread":"0.02"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52","description":"Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmol/L","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"170"},{"groupId":"OG001","value":"177"},{"groupId":"OG002","value":"176"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.07","spread":"0.02"},{"groupId":"OG001","value":"-0.10","spread":"0.02"},{"groupId":"OG002","value":"-0.06","spread":"0.02"}]}]}]},{"type":"SECONDARY","title":"Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78","description":"Mean change in free fatty acids (FFA) from Week 52 to Week 78.","populationDescription":"Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 52, Week 78","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"60"},{"groupId":"OG004","value":"65"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG003","value":"0.02","spread":"0.3"},{"groupId":"OG004","value":"-0.01","spread":"0.3"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Apolipoprotein B at Week 26","description":"Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"g/L","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"164"},{"groupId":"OG001","value":"175"},{"groupId":"OG002","value":"182"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.06","spread":"0.01"},{"groupId":"OG001","value":"-0.07","spread":"0.01"},{"groupId":"OG002","value":"-0.05","spread":"0.01"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Apolipoprotein B at Week 52","description":"Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"g/L","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"184"},{"groupId":"OG001","value":"192"},{"groupId":"OG002","value":"195"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.03","spread":"0.01"},{"groupId":"OG001","value":"-0.03","spread":"0.01"},{"groupId":"OG002","value":"-0.03","spread":"0.01"}]}]}]},{"type":"SECONDARY","title":"Mean Change in Apolipoprotein B From Week 52 to Week 78","description":"Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78.","populationDescription":"Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Week 52, Week 78","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"66"},{"groupId":"OG004","value":"68"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG003","value":"0.23","spread":"0.4"},{"groupId":"OG004","value":"0.17","spread":"0.4"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26","description":"Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/L","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"205"},{"groupId":"OG001","value":"209"},{"groupId":"OG002","value":"205"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.02","spread":"0.31"},{"groupId":"OG001","value":"-0.99","spread":"0.31"},{"groupId":"OG002","value":"-0.66","spread":"0.31"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26.","description":"Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"U/L","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"188"},{"groupId":"OG001","value":"198"},{"groupId":"OG002","value":"182"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-833","spread":"945.1"},{"groupId":"OG001","value":"-561","spread":"941.1"},{"groupId":"OG002","value":"586","spread":"952"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26.","description":"Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"pg/mL","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"204"},{"groupId":"OG001","value":"210"},{"groupId":"OG002","value":"206"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.70","spread":"2.49"},{"groupId":"OG001","value":"1.71","spread":"2.47"},{"groupId":"OG002","value":"0.91","spread":"2.49"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.","description":"Calculated as an estimate of the mean change from baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"pmol/L","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"204"},{"groupId":"OG001","value":"209"},{"groupId":"OG002","value":"205"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5.19","spread":"2.07"},{"groupId":"OG001","value":"3.74","spread":"2.06"},{"groupId":"OG002","value":"3.71","spread":"2.07"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Adiponectin at Week 26.","description":"Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mcg/mL","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"202"},{"groupId":"OG001","value":"210"},{"groupId":"OG002","value":"207"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.69","spread":"0.19"},{"groupId":"OG001","value":"1.51","spread":"0.19"},{"groupId":"OG002","value":"1.35","spread":"0.19"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.","description":"Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"pg/mL","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"195"},{"groupId":"OG001","value":"204"},{"groupId":"OG002","value":"196"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.55","spread":"0.25"},{"groupId":"OG001","value":"-0.74","spread":"0.25"},{"groupId":"OG002","value":"-0.53","spread":"0.25"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26.","description":"Calculated as an estimate of the mean change from baseline in von Willebrand Factor (vWf) at Week 26. vWf is a blood glycoprotein involved in haemostasis.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage point","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"189"},{"groupId":"OG001","value":"193"},{"groupId":"OG002","value":"183"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.73","spread":"2.77"},{"groupId":"OG001","value":"-4.34","spread":"2.76"},{"groupId":"OG002","value":"-1.8","spread":"2.82"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Waist to Hip Ratio at Week 26.","description":"Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 26. The measure is assessed as the circumference of the waist divided by the circumference of the hip.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"cm/cm","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"210"},{"groupId":"OG001","value":"208"},{"groupId":"OG002","value":"207"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.01","spread":"0.00"},{"groupId":"OG001","value":"-0.01","spread":"0.00"},{"groupId":"OG002","value":"-0.00","spread":"0.00"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Waist to Hip Ratio at Week 52","description":"Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 52. The measure is assessed as the circumference of the waist divided by the circumference of the hip.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"cm/cm","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"210"},{"groupId":"OG001","value":"208"},{"groupId":"OG002","value":"207"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.00","spread":"0.00"},{"groupId":"OG001","value":"-0.01","spread":"0.00"},{"groupId":"OG002","value":"-0.00","spread":"0.00"}]}]}]},{"type":"SECONDARY","title":"Mean Change in Waist to Hip Ratio From Week 52 to Week 78","description":"Mean change in Waist to Hip Ratio from Week 52 to Week 78. The measure is assessed as the circumference of the waist divided by the circumference of the hip.","populationDescription":"Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"cm/cm","timeFrame":"Week 52, Week 78","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"66"},{"groupId":"OG004","value":"67"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG003","value":"-0.01","spread":"0"},{"groupId":"OG004","value":"-0.00","spread":"0"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Waist Circumference at Week 26.","description":"Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"cm","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"210"},{"groupId":"OG001","value":"208"},{"groupId":"OG002","value":"208"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.69","spread":"0.35"},{"groupId":"OG001","value":"-2.63","spread":"0.36"},{"groupId":"OG002","value":"-1.12","spread":"0.36"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Waist Circumference at Week 52","description":"Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"participants","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"210"},{"groupId":"OG001","value":"208"},{"groupId":"OG002","value":"208"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.36","spread":"0.38"},{"groupId":"OG001","value":"-3.02","spread":"0.38"},{"groupId":"OG002","value":"-1.23","spread":"0.38"}]}]}]},{"type":"SECONDARY","title":"Mean Change in Waist Circumference From Week 52 to Week 78","description":"Mean change in Waist Circumference from Week 52 to Week 78.","populationDescription":"Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kg","timeFrame":"Week 52, Week 78","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"66"},{"groupId":"OG004","value":"68"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG003","value":"-1.33","spread":"3.5"},{"groupId":"OG004","value":"-2.05","spread":"4.1"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26","description":"Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmHg","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"213"},{"groupId":"OG001","value":"214"},{"groupId":"OG002","value":"213"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.55","spread":"0.89"},{"groupId":"OG001","value":"-0.72","spread":"0.89"},{"groupId":"OG002","value":"-0.94","spread":"0.89"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52","description":"Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmHg","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"213"},{"groupId":"OG001","value":"214"},{"groupId":"OG002","value":"213"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.37","spread":"0.93"},{"groupId":"OG001","value":"-2.55","spread":"0.93"},{"groupId":"OG002","value":"-1.03","spread":"0.93"}]}]}]},{"type":"SECONDARY","title":"Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78","description":"Mean change in systolic blood pressure (SBP) from Week 52 to Week 78.","populationDescription":"Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmHg","timeFrame":"Week 52, Week 78","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"67"},{"groupId":"OG004","value":"68"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG003","value":"-2.12","spread":"14.6"},{"groupId":"OG004","value":"0.35","spread":"12.4"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26","description":"Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmHg","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"213"},{"groupId":"OG001","value":"214"},{"groupId":"OG002","value":"213"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.71","spread":"0.60"},{"groupId":"OG001","value":"0.07","spread":"0.59"},{"groupId":"OG002","value":"-1.78","spread":"0.60"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52","description":"Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmHg","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"213"},{"groupId":"OG001","value":"214"},{"groupId":"OG002","value":"213"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.53","spread":"0.57"},{"groupId":"OG001","value":"-0.87","spread":"0.57"},{"groupId":"OG002","value":"-1.47","spread":"0.57"}]}]}]},{"type":"SECONDARY","title":"Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78","description":"Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78.","populationDescription":"Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmHg","timeFrame":"Week 52, Week 78","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"67"},{"groupId":"OG004","value":"68"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG003","value":"-0.60","spread":"10.0"},{"groupId":"OG004","value":"0.03","spread":"8.9"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Pulse at Week 26","description":"Calculated as an estimate of the mean change from baseline in pulse at Week 26.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"beats/minute","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"212"},{"groupId":"OG001","value":"214"},{"groupId":"OG002","value":"211"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.32","spread":"0.59"},{"groupId":"OG001","value":"3.94","spread":"0.58"},{"groupId":"OG002","value":"-0.64","spread":"0.59"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Pulse at Week 52","description":"Calculated as an estimate of the mean change from baseline in pulse at Week 52.","populationDescription":"FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmHg","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"212"},{"groupId":"OG001","value":"214"},{"groupId":"OG002","value":"211"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.72","spread":"0.60"},{"groupId":"OG001","value":"3.09","spread":"0.60"},{"groupId":"OG002","value":"0.09","spread":"0.60"}]}]}]},{"type":"SECONDARY","title":"Mean Change in Pulse From Week 52 to Week 78","description":"Mean change in pulse from Week 52 to Week 78.","populationDescription":"Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"beats/minute","timeFrame":"Week 52, Week 78","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"67"},{"groupId":"OG004","value":"68"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG003","value":"0.90","spread":"8.4"},{"groupId":"OG004","value":"2.19","spread":"7.7"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26","description":"The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.","populationDescription":"Patient Reported Outcome Analysis Set consisted of all subjects in the FAS, except subjects from countries Serbia, Slovakia and Slovenia","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Week 0, Week 26","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"164"},{"groupId":"OG001","value":"171"},{"groupId":"OG002","value":"170"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.51","spread":"0.49"},{"groupId":"OG001","value":"4.35","spread":"0.48"},{"groupId":"OG002","value":"2.96","spread":"0.48"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52","description":"The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.","populationDescription":"Patient Reported Outcome Analysis Set consisted of all subjects in the FAS, except subjects from countries Serbia, Slovakia and Slovenia","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Week 0, Week 52","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"165"},{"groupId":"OG002","value":"169"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.32","spread":"0.49"},{"groupId":"OG001","value":"4.31","spread":"0.48"},{"groupId":"OG002","value":"2.96","spread":"0.48"}]}]}]},{"type":"SECONDARY","title":"Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78","description":"The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.","populationDescription":"Extension 2 Patient Reported Outcome Analysis Set consisted of all subjects in the Extension 2 FAS, except subjects from countries Serbia, Slovakia and Slovenia","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"scores on a scale","timeFrame":"Week 52, Week 78","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"54"},{"groupId":"OG004","value":"48"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG003","value":"1.48","spread":"4.4"},{"groupId":"OG004","value":"0.98","spread":"6.1"}]}]}]},{"type":"SECONDARY","title":"Hypoglyceamic Episodes, Weeks 0-26","description":"Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.","populationDescription":"The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"episodes","timeFrame":"Weeks 0-26","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"221"},{"groupId":"OG001","value":"218"},{"groupId":"OG002","value":"219"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"title":"Major","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Minor","categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"11"}]}]},{"title":"Symptoms only","categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"10"}]}]},{"title":"Unclassified","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]}]},{"type":"SECONDARY","title":"Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26","description":"Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.","populationDescription":"The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 21 minor hypoglycaemic episodes was excluded from this analysis.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"episodes","timeFrame":"Weeks 0-26","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"221"},{"groupId":"OG001","value":"217"},{"groupId":"OG002","value":"219"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"title":"Major","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Minor","categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"11"}]}]},{"title":"Symptoms only","categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"10"}]}]},{"title":"Unclassified","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]}]},{"type":"SECONDARY","title":"Hypoglyceamic Episodes, Weeks 0-52","description":"Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.","populationDescription":"The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"episodes","timeFrame":"Weeks 0-52","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"221"},{"groupId":"OG001","value":"218"},{"groupId":"OG002","value":"219"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"title":"Major","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Minor","categories":[{"measurements":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"51"},{"groupId":"OG002","value":"25"}]}]},{"title":"Symptoms only","categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"29"},{"groupId":"OG002","value":"12"}]}]},{"title":"Unclassified","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]}]},{"type":"SECONDARY","title":"Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52","description":"Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.","populationDescription":"The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 23 minor hypoglycaemic episodes was excluded from this analysis.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"episodes","timeFrame":"Weeks 0-52","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"221"},{"groupId":"OG001","value":"218"},{"groupId":"OG002","value":"219"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"title":"Major","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Minor","categories":[{"measurements":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"28"},{"groupId":"OG002","value":"25"}]}]},{"title":"Symptoms only","categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"29"},{"groupId":"OG002","value":"12"}]}]},{"title":"Unclassified","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]}]},{"type":"SECONDARY","title":"Hypoglyceamic Episodes, Weeks 0-78","description":"Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.","populationDescription":"The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"episodes","timeFrame":"Weeks 0-78","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"221"},{"groupId":"OG001","value":"218"},{"groupId":"OG002","value":"219"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"title":"Major","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Minor","categories":[{"measurements":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"56"},{"groupId":"OG002","value":"34"}]}]},{"title":"Symptoms only","categories":[{"measurements":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"13"}]}]},{"title":"Unclassified","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]}]},{"type":"SECONDARY","title":"Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78","description":"Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.","populationDescription":"The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 23 minor hypoglycaemic episodes was excluded from this analysis.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"episodes","timeFrame":"Weeks 0-78","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"221"},{"groupId":"OG001","value":"218"},{"groupId":"OG002","value":"219"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"classes":[{"title":"Major","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Minor","categories":[{"measurements":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"33"},{"groupId":"OG002","value":"34"}]}]},{"title":"Symptoms only","categories":[{"measurements":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"13"}]}]},{"title":"Unclassified","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]}]},{"type":"SECONDARY","title":"Hypoglycaamic Episodes, Weeks 52-78","description":"Number of hypoglycaemic episodes from Week 52 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.","populationDescription":"Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"episodes","timeFrame":"Week 52-78","groups":[{"id":"OG000","title":"Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg","description":"Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG001","title":"Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg","description":"Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78)."},{"id":"OG002","title":"Sita -> Sita","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52)."},{"id":"OG003","title":"Sita -> Sita -> Lira 1.2 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin."},{"id":"OG004","title":"Sita -> Sita -> Lira 1.8 mg","description":"Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). 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