Rimonabant In Prediabetic Subjects To Delay Onset Of Type 2 Diabetes

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Prediabetic State

In brief

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.

Key facts

Study ID

NCT00325650

Run by

Sanofi

People needed

2420

Starts

2006-05-01

Expected to finish

2009-03-01

Last updated by the study team

2016-05-18

Who can join

Age: 35 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;

Where it is running

• Sanofi-Aventis — Bridgewater, New Jersey, United States

Full record on ClinicalTrials.gov

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