The primary objective is to demonstrate, after 52 weeks of treatment, the non-inferiority of rimonabant 20 mg once daily (od) versus glimepiride od in reducing glycosylated haemoglobin (HbA1c) in overweight/obese patients with type 2 diabetes not adequately controlled with metformin at a stable dose (≥ 1500 mg/day) for at least 3 months. The main secondary objectives are to assess the effect of rimonabant in comparison with glimepiride on body weight and HDL-Cholesterol and the long-term safety and tolerability of rimonabant in comparison with glimepiride.
The total duration per patient will be approximately 65 weeks including a 52-week double-blind treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
508
Tablet, oral administration
Tablet, oral administration
Metformin continued at stable dose as background therapy
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Santiago, Chile
Sanofi-aventis adminsitrative office
Santiago, Chile
Change from baseline in glycemic measure HbA1c
Time frame: 52 weeks (1 year)
Absolute change from baseline in body weight
Time frame: 52 weeks
Relative change from baseline in HDL-C
Time frame: 52 weeks
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