Status:
TERMINATED
Rimonabant In Prediabetic Subjects To Delay Onset Of Type 2 Diabetes
Lead Sponsor:
Sanofi
Conditions:
Prediabetic State
Eligibility:
All Genders
35-75 years
Phase:
PHASE3
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 ...
Detailed Description
The total duration per patient will be approximately 38 months including a 30-month double-blind treatment period.
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
2420 Patients enrolled
Trial Details
Trial ID
NCT00325650
Start Date
May 1 2006
End Date
March 1 2009
Last Update
May 18 2016
Active Locations (1)
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1
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807