RAPSODI: Rimonabant In Prediabetic Subjects To Delay Onset Of Type 2 Diabetes
Study Details
Study Description
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 Impaired Glucose Tolerance (IGT) or both at baseline).
Secondary objectives:
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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),
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To assess the effect on quality of life
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To evaluate long term safety and tolerability.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
The total duration per patient will be approximately 38 months including a 30-month double-blind treatment period.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Rimonabant Rimonabant 20 mg once daily |
Drug: Rimonabant
Tablet, oral administration
Other Names:
|
| Placebo Comparator: Placebo Placebo (for Rimonabant) once daily. |
Drug: Placebo (for Rimonabant)
Tablet, oral administration
|
Outcome Measures
Primary Outcome Measures
- Time of progression to type 2 diabetes [Baseline to 30 months]
Secondary Outcome Measures
- Change from baseline in body weight [Baseline to 30 months]
- Change from baseline in waist circumference [Baseline to 30 months]
- Change from baseline in in glucose homeostasis (HbA1C, fasting plasma glucose and fasting insulin) [Baseline to 30 months]
- Change from baseline in glucose and insulin at 2 hour post-glucose load [Baseline to 30 months]
- Change from baseline in HDL-Cholesterol and triglycerides (TG) [Baseline to 30 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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No previous history of treatment for type 2 diabetes.
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Diagnosis of :
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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.
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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:
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Absence of effective contraceptive method for females of childbearing potential.
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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.
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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.
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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.
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Related to laboratory findings:
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positive test for hepatitis B surface antigen and/or hepatitis C antibody;
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Positive urine pregnancy test in females of childbearing potential ;
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Thyroid-stimulating hormone (TSH) and free T4 outside central laboratory normal range.
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Related to previous or concomitant medications:
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Within 3 months prior to screening visit and/or during the screening period:
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anti-obesity drugs (e.g., sibutramine, orlistat, herbal preparations, etc),
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systemic long-acting corticosteroids; prolonged use (more than 10 days) of systemic corticosteroids;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanofi-Aventis | Bridgewater | New Jersey | United States | 08807 |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: ICD CSD, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EFC5107