Clinical Trial: Rimonabant In Prediabetic Subjects To Delay Onset Of Type 2 Diabetes

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: 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 Pa

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

Current Primary Outcome: Time of progression to type 2 diabetes [ Time Frame: Baseline to 30 months ]

Original Primary Outcome: Time of progression to type 2 diabetes

Current Secondary Outcome:

  • Change from baseline in body weight [ Time Frame: Baseline to 30 months ]
  • Change from baseline in waist circumference [ Time Frame: Baseline to 30 months ]
  • Change from baseline in in glucose homeostasis (HbA1C, fasting plasma glucose and fasting insulin) [ Time Frame: Baseline to 30 months ]
  • Change from baseline in glucose and insulin at 2 hour post-glucose load [ Time Frame: Baseline to 30 months ]
  • Change from baseline in HDL-Cholesterol and triglycerides (TG) [ Time Frame: Baseline to 30 months ]


Original Secondary Outcome: Body weight, waist circumference, sustained effect following a washout period, HbA1C, fasting plasma glucose and 2-h post-glucose load plasma glucose, fasting insulin and 2-h post-glucose load insulin, HDL-Cholesterol and TG

Information By: Sanofi

Dates:
Date Received: May 12, 2006
Date Started: May 2006
Date Completion:
Last Updated: April 19, 2016
Last Verified: April 2016