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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
Information provided by (Responsible Party):

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:

  • 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

Detailed Description:
The total duration per patient will be approximately 38 months including a 30-month double-blind treatment period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
Experimental: Rimonabant
Rimonabant 20 mg once daily
Drug: Rimonabant
Tablet, oral administration
Other Names:
  • SR141716
  • Acomplia

Placebo Comparator: Placebo
Placebo (for Rimonabant) once daily.
Drug: Placebo (for Rimonabant)
Tablet, oral administration

Primary Outcome Measures :
  1. Time of progression to type 2 diabetes [ Time Frame: Baseline to 30 months ]

Secondary Outcome Measures :
  1. Change from baseline in body weight [ Time Frame: Baseline to 30 months ]
  2. Change from baseline in waist circumference [ Time Frame: Baseline to 30 months ]
  3. Change from baseline in in glucose homeostasis (HbA1C, fasting plasma glucose and fasting insulin) [ Time Frame: Baseline to 30 months ]
  4. Change from baseline in glucose and insulin at 2 hour post-glucose load [ Time Frame: Baseline to 30 months ]
  5. Change from baseline in HDL-Cholesterol and triglycerides (TG) [ Time Frame: Baseline to 30 months ]

Information from the National Library of Medicine

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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

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;

Information from the National Library of Medicine

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

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United States, New Jersey
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
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Study Director: ICD CSD Sanofi
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00325650    
Other Study ID Numbers: EFC5107
First Posted: May 15, 2006    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: April 2016
Keywords provided by Sanofi:
Prediabetic state
Impaired fasting glucose
Impaired glucose Tolerance
Additional relevant MeSH terms:
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Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Anti-Obesity Agents
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs