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.
The total duration per patient will be approximately 38 months including a 30-month double-blind treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2,420
Tablet, oral administration
Tablet, oral administration
Sanofi-Aventis
Bridgewater, New Jersey, United States
Time of progression to type 2 diabetes
Time frame: Baseline to 30 months
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.