Rimonabant In Prediabetic Subjects To Delay Onset Of Type 2 Diabetes

• Status: Terminated
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Rimonabant

Criteria

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;