Primary: To assess the effects of rimonabant on HbA1c in patients with Type 2 diabetes who are overweight or obese (Body Mass Index (BMI) \> 27 kg/m² and BMI \< 40 kg/m²), have uncontrolled HbA1c (7.0% - 9.0% inclusive) and are currently on maximal tolerated doses of two Oral Anti Diabetic medications - Metformin (Met) and Sulfonylurea (SU). Secondary: To assess the effects of rimonabant on Anthropometric measures, Glucose measures, Lipid measures, Other measures and changes in quality of life
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
358
White opaque film-coated, for oral administration containing 20 mg of active rimonabant. Once daily before breakfast
Matching placebo tablets. Once daily before breakfast
Sanofi-Aventis Administrative Office
North Ryde, Australia
Absolute change in HbA1c between both placebo and rimonabant group.
Time frame: From baseline to week 48
Percentage of participants reaching the treat-to-target objective of HbA1c ≤ 6.5% and ≤ 7.0%
Time frame: From the beginning to the end of the study
Percentage of participants responding to treatment
Time frame: From the beginning to the end of study
Rate of asymptomatic, symptomatic, and severe hypoglycaemia
Time frame: From the beginning to the end of the study
Change in physical examinations, vital signs, laboratory parameters, adverse events
Time frame: From the beginning to the end of the study
Change in insulin sensitivity, fasting plasma glucose, hypoglycaemia rate.
Time frame: From the beginning to the end of the study
Change in BMI, waist and hip circumference, waist/hip ratio, weight
Time frame: From the beginning to the end of the study
Changes in Quality of Life
Time frame: From the beginning to the end of the study
Change in lipid measures: HDL (High Density Lipoprotein), LDL (Low-Density Lipoprotein), TG (Triglycerides), TC (Total Cholesterol), ApoB (Apolipoprotein B)
Time frame: From administration of drug till end of study
Change in adiponectin, fasting insulin, Blood Pressure, concomitant medications, health resource use, CRP (C Reactive Protein), ALT (Alanine Aminotransferase), albumin/creatinine ratio
Time frame: From administration of drug to end of study
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