Rimonabant In Prediabetic Subjects To Delay Onset Of Type 2 Diabetes (RAPSODI)

This study has been terminated.
(Company decision taken in light of demands by certain national health authorities)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00325650
First received: May 12, 2006
Last updated: June 12, 2009
Last verified: June 2009
  Purpose

Primary: effect of long-term administration 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: Effect on weight loss and weight maintenance, sustained effect of rimonabant following a washout period, other markers of glycemic control (fasting glucose, fasting-insulin and HbA1c), glucose tolerance and insulin responses during OGTTs, other risk factors (HDL-Cholesterol, TG), quality of life - Safety and tolerability.


Condition Intervention Phase
Prediabetic State
Drug: rimonabant (SR141716)
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Time of progression to type 2 diabetes [ Time Frame: study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body weight, waist circumference, sustained effect following a washout period, HbA1C, fasting plasma glucose and 2-h post-glucose load plasma glucose, fasting insulin and 2-h post-glucose load insulin, HDL-Cholesterol and TG [ Time Frame: study period ] [ Designated as safety issue: No ]

Enrollment: 2420
Study Start Date: May 2006
Study Completion Date: March 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: rimonabant (SR141716)
oral administration once daily
Placebo Comparator: 2 Drug: placebo
oral administration once daily

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • No previous history of treatment for type 2 diabetes.
  • Diagnosis of :

    • IGT based on one 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 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 ;
    • 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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00325650

Locations
United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00325650     History of Changes
Other Study ID Numbers: EFC5107
Study First Received: May 12, 2006
Last Updated: June 12, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Prediabetic state
Impaired fasting glucose
Impaired glucose Tolerance

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Glucose Intolerance
Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia

ClinicalTrials.gov processed this record on April 17, 2014