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 (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00325650
First received: May 12, 2006
Last updated: April 19, 2016
Last verified: April 2016
  Purpose

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 Intervention Phase
Prediabetic State
Drug: Rimonabant
Drug: Placebo (for Rimonabant)
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Time of progression to type 2 diabetes [ Time Frame: Baseline to 30 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in body weight [ Time Frame: Baseline to 30 months ] [ Designated as safety issue: No ]
  • Change from baseline in waist circumference [ Time Frame: Baseline to 30 months ] [ Designated as safety issue: No ]
  • Change from baseline in in glucose homeostasis (HbA1C, fasting plasma glucose and fasting insulin) [ Time Frame: Baseline to 30 months ] [ Designated as safety issue: No ]
  • Change from baseline in glucose and insulin at 2 hour post-glucose load [ Time Frame: Baseline to 30 months ] [ Designated as safety issue: No ]
  • Change from baseline in HDL-Cholesterol and triglycerides (TG) [ Time Frame: Baseline to 30 months ] [ Designated as safety issue: No ]

Enrollment: 2420
Study Start Date: May 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00325650     History of Changes
Other Study ID Numbers: EFC5107 
Study First Received: May 12, 2006
Last Updated: April 19, 2016
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Glucose Intolerance
Prediabetic State
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Rimonabant
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2016