drugset / Trial / NCT00478595

Japanese Study With Rimonabant in Obese Type 2 Diabetic Patients With Oral Anti-diabetic Drug

NCT00478595

Phase 3 Terminated 458 enrolled Sanofi
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2007-04
Primary completion
2009-02
Completion
2009-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Rimonabant Small molecule 20 mg Oral