NCT00325650

Rimonabant In Prediabetic Subjects To Delay Onset Of Type 2 Diabetes

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess the Efficacy and Safety of Long-term Administration of Rimonabant in the Prevention of Type 2 Diabetes in Patients With Prediabetic Status (i.e., Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or Both)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,420 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The total duration per patient will be approximately 38 months including a 30-month double-blind treatment period.

Conditions

• Prediabetic State

Interventions

Type	Name	Description
DRUG	Rimonabant	Tablet, oral administration
DRUG	Placebo (for Rimonabant)	Tablet, oral administration

Timeline

• Start date: 2006-05-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2006-05-15
• Last updated: 2016-05-18

Locations

1 site across 1 country: United States