Rimonabant In Prediabetic Subjects To Delay Onset Of Type 2 Diabetes (RAPSODI)
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|ClinicalTrials.gov Identifier: NCT00325650|
Recruitment Status : Terminated (Company decision taken in light of demands by certain national health authorities)
First Posted : May 15, 2006
Last Update Posted : May 18, 2016
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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).
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Prediabetic State||Drug: Rimonabant Drug: Placebo (for Rimonabant)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2420 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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)|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
Rimonabant 20 mg once daily
Tablet, oral administration
Placebo Comparator: Placebo
Placebo (for Rimonabant) once daily.
Drug: Placebo (for Rimonabant)
Tablet, oral administration
- Time of progression to type 2 diabetes [ Time Frame: Baseline to 30 months ]
- Change from baseline in body weight [ Time Frame: Baseline to 30 months ]
- Change from baseline in waist circumference [ Time Frame: Baseline to 30 months ]
- Change from baseline in in glucose homeostasis (HbA1C, fasting plasma glucose and fasting insulin) [ Time Frame: Baseline to 30 months ]
- Change from baseline in glucose and insulin at 2 hour post-glucose load [ Time Frame: Baseline to 30 months ]
- Change from baseline in HDL-Cholesterol and triglycerides (TG) [ Time Frame: Baseline to 30 months ]
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|Ages Eligible for Study:||35 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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;
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00325650
|United States, New Jersey|
|Bridgewater, New Jersey, United States, 08807|
|Study Director:||ICD CSD||Sanofi|
|Other Study ID Numbers:||
|First Posted:||May 15, 2006 Key Record Dates|
|Last Update Posted:||May 18, 2016|
|Last Verified:||April 2016|
Impaired fasting glucose
Impaired glucose Tolerance
Glucose Metabolism Disorders
Endocrine System Diseases
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs