| Outcome Measures: |
Primary: Percentage of Patients Achieving Glycosylated Hemoglobin (HbA1c) Concentration ≤7.0% With Weight Loss (≥1.0 kg) at Endpoint (Week 26), The primary endpoint is the percentage of patients achieving HbA1c concentration ≤7.0% with weight loss (≥1.0 kg) at endpoint. The last post-baseline measurement set of both non-missing HbA1c concentration and weight (measured at the same time point, i.e. visit) is used as endpoint value. Patients who do not have a baseline weight measurement, have a protocol violation of baseline HbA1c \<=7.0%, and/or have missing post-baseline measurements for HbA1c concentration and/or weight, are included in the analysis as non-responders regarding the primary objective., Baseline, Week 26 | Secondary: Percentage of Patients Who Have Achieved HbA1c ≤7.4% With Weight Loss (≥1.0 kg) at Endpoint (Week 26), Percentage of patients who have achieved HbA1c ≤7.4% with weight loss (≥1.0 kg) at endpoint (Week 26), Baseline, Week 26|Change in HbA1c From Baseline to Week 26, Change in HbA1c from baseline to week 26, Baseline, Week 26|Change in Body Weight From Baseline to Week 26, Change in body weight from baseline to week 26, Baseline, Week 26|Percentage of Patients Achieving HbA1c ≤7.4% at Endpoint, Percentage of patients who have achieved HbA1c ≤.7.4% at endpoint, Week 26|Percentage of Patients Achieving ≤7.0% at Endpoint, Percentage of patients achieving ≤7.0% at endpoint., Week 26|Percentage of Patients Achieving ≤6.5% at Endpoint, Percentage of patients achieving HbA1c ≤6.5% at endpoint, Week 26|Change in Fasting Serum Glucose From Baseline to Endpoint (Week 26)., Change in fasting serum glucose from baseline to endpoint (Week 26)., Baseline, Week 26|Changes in Systolic Blood Pressure From Baseline to Week 26, Change in systolic blood pressure from baseline to Week 26, Baseline, Week 26|Change in Diastolic Blood Pressure From Baseline to Week 26., Change in diastolic blood pressure from baseline to week 26., Baseline, Week 26|Change in Total Cholesterol From Baseline to Endpoint (Week 26)., Change in total cholesterol from baseline to endpoint (week 26)., Baseline, Week 26|Change in High-density Lipoprotein (HDL) Cholesterol From Baseline to Endpoint (Week 26)., Change in High-density lipoprotein (HDL) cholesterol from baseline to endpoint (week 26)., Baseline, Week 26|Change in Triglycerides From Baseline to Endpoint (Week 26)., Change in triglycerides from baseline to endpoint (week 26)., Baseline, Week 26|Hypoglycemia Rate Per Year, All confirmed hypoglycemia episodes defined as either minor (any time a patient feels that he or she is experiencing a sign or symptom associated with hypoglycaemia and blood glucose (BG) \<3.0 mmol/L (54 mg/dL)) or major (any hypoglycaemic episode with symptoms consistent with hypoglycaemia, resulting in loss of consciousness or seizure, and shows prompt recovery in response to administration of glucagon or glucose, or BG measurement \< 3.0mmol/L is available and the patient is not capable of self-treating were taken into account., Baseline, Week 26
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| Locations: |
Research Site, Dublin, Ireland|Research Site, Addlestone, England, United Kingdom|Research Site, Bath, England, United Kingdom|Research Site, Birmingham, England, United Kingdom|Research Site, Blackburn, England, United Kingdom|Research Site, Bournemouth, England, United Kingdom|Research Site, Chippenham, England, United Kingdom|Research Site, Derby, England, United Kingdom|Research Site, Exeter, England, United Kingdom|Research Site, High Wycombe, England, United Kingdom|Research Site, Hull, England, United Kingdom|Research Site, Leicester, England, United Kingdom|Research Site, Liverpool, England, United Kingdom|Research Site, London, England, United Kingdom|Research Site, Manchester, England, United Kingdom|Research Site, Merseyside, England, United Kingdom|Research Site, Middlesborough, England, United Kingdom|Research Site, Newcastle, England, United Kingdom|Research Site, Northampton, England, United Kingdom|Research Site, Oldham, England, United Kingdom|Research Site, Plymouth, England, United Kingdom|Research Site, Portsmouth, England, United Kingdom|Research Site, Sheffield, England, United Kingdom|Research Site, Stevenage, England, United Kingdom|Research Site, Suffolk, England, United Kingdom|Research Site, Wakefield, England, United Kingdom|Research Site, Wiltshire, England, United Kingdom|Research Site, Aberdeen, Scotland, United Kingdom|Research Site, Dundee, Scotland, United Kingdom|Research Site, Carmathen, Wales, United Kingdom|Research Site, Swansea, Wales, United Kingdom|Research Site, Wrexham, Wales, United Kingdom|Research Site, Leytonstone, United Kingdom|Research Site, Livingston, United Kingdom
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