drugset
drugset / Trial / NCT00754689

Study of Rimonabant/Metformin Combinations to Investigate Diabetes (Blood Sugar) Control in Patients With Type 2 Diabetes

NCT00754689 ↗

Phase 3 Withdrawn Sanofi
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of the study is to demonstrate superiority of rimonabant/metformin combinations in Glycosylated Hemoglobin 1c (A1C) reduction over the corresponding single agent metformin and over rimonabant alone in patients with type 2 diabetes mellitus at 9 months. The secondary objective is to investigate the effects of rimonabant/metformin combinations for reducing fasted plasma glucose, body weight and triglycerides, and raising High Density Lipoprotein Cholesterol (HDL-C) in comparison with metformin at 9 months. Another objective is to evaluate the safety of rimonabant in combination with metformin over a period of up to 52 weeks.

Timeline

Start
2008-09
Primary completion
2008-11
Completion
2008-11

Outcome

Outcome not reported

Stopped: “Company decision taken in light of demands by certain national health authorities”

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 500 mg Oral
Subject Metformin Small molecule 1000 mg Oral
Subject Rimonabant Small molecule 10 mg Oral
Subject Rimonabant Small molecule 20 mg Oral

Indications

type 2 diabetes mellitus