drugset / Trial / NCT00449605

A Glycemic Control Evaluation of Glimepiride Versus Rimonabant on Top of Metformin in Type 2 Diabetes

NCT00449605

Phase 3 Terminated 508 enrolled Sanofi
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2007-03
Primary completion
2008-11
Completion
2009-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Glimepiride Small molecule 6 mg Oral
Subject Rimonabant Small molecule 20 mg Oral
Background Metformin Small molecule 1500 mg