drugset / Trial / NCT00449605
A Glycemic Control Evaluation of Glimepiride Versus Rimonabant on Top of Metformin in Type 2 Diabetes
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Glimepiride | Small molecule | 6 mg | Oral |
| Subject | Rimonabant | Small molecule | 20 mg | Oral |
| Background | Metformin | Small molecule | 1500 mg | — |