drugset / Trial / NCT00325650

Rimonabant In Prediabetic Subjects To Delay Onset Of Type 2 Diabetes

NCT00325650

Phase 3 Terminated 2420 enrolled Sanofi
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Primary objective: To evaluate the effect of long-term administration of Rimonabant on the time of progression to type 2 diabetes in patients with prediabetes (i.e. Impaired Fasting Glucose (IFG) or Impaired Glucose Tolerance (IGT) or both at baseline). Secondary objectives: * To assess the effect on weight loss and weight maintenance; sustained effect following a washout period, effect on other markers of glycemic control (fasting glucose, fasting-insulin and HbA1c), glucose tolerance and insulin responses during oral glucose tolerance tests (OGTTs), and on other risk factors (HDL-Cholesterol, TG), * To assess the effect on quality of life * To evaluate long term safety and tolerability.

Timeline

Start
2006-05
Primary completion
2009-03
Completion
2009-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Rimonabant Small molecule 20 mg Oral

Indications