The primary objective of this study is to assess the efficacy of Rimonabant (SR141716) compared to placebo on change in HbA1c and on relative change in body weight over 52 weeks in obese type 2 diabetic patients on monotherapy inadequately controlled with oral anti-diabetic drug (sulfonylurea or α-glucosidase inhibitor). The secondary objectives are: * To evaluate the effect of Rimonabant compared to placebo on other parameters related to the glucose control, waist circumference, Body Mass Index and metabolic parameters; * To evaluate the safety and tolerability of Rimonabant compared to placebo; * To evaluate the pharmacokinetics of Rimonabant.
The total duration per patient will be approximately 69 weeks including a 52-week double-blind treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
458
Tablet, oral administration
Tablet, oral administration
Previous treatment with Sulfonylurea or α-glucosidase inhibitor continued at stable dose during the study period
Sanofi-Aventis Administrative Office
Tokyo, Japan
Absolute change from baseline in HbA1C
Time frame: Baseline to week 52
Relative change from baseline in in body weight
Time frame: Baseline to week 52
Absolute change from baseline in Fasting Plasma Glucose
Time frame: Baseline to week 52
Absolute change from baseline in waist circumference
Time frame: Baseline to week 52
Relative change from baseline in Triglycerides and HDL-cholesterol
Time frame: Baseline to week 52
Safety: overview of adverse events
Time frame: Baseline to Week 56
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