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)

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.

Inclusion Criteria:

• No previous history of treatment for type 2 diabetes.

• Diagnosis of :

  • Impaired Glucose Tolerance (IGT) based on one oral glucose tolerance test (OGTT) and defined as a 2 hour post-challenge glucose (after a 75-g Oral Glucose Tolerance Test) > 140 mg/dL (7.8 mmol/L) but < 200 mg/dL (11.1 mmol/L), at the screening visit.
  • And / or impaired fasting glucose (IFG) based on a Fasting Plasma Glucose (FPG) ³ 100 mg/dL (5.6 mmol/L) and < 126 mg/dL (7.0 mmol/L), at the screening visit.

Exclusion Criteria:

• Absence of effective contraceptive method for females of childbearing potential.

• Presence of any clinically significant endocrine disease according to the Investigator.Note: euthyroid patients on replacement therapy will be included if the dosage of thyroxine is stable for at least 3 months prior to screening visit.

• Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study.

• Presence or history of cancer within the past five years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer.

• Related to laboratory findings:

  • positive test for hepatitis B surface antigen and/or hepatitis C antibody;
  • Positive urine pregnancy test in females of childbearing potential ;
  • Thyroid-stimulating hormone (TSH) and free T4 outside central laboratory normal range.

• Related to previous or concomitant medications:

  • Within 3 months prior to screening visit and/or during the screening period:

    • anti-obesity drugs (e.g., sibutramine, orlistat, herbal preparations, etc),
    • systemic long-acting corticosteroids; prolonged use (more than 10 days) of systemic corticosteroids;