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

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)

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.

Study Overview

• Status: Terminated
• Conditions: Prediabetic State
• Intervention / Treatment: Drug: Rimonabant; Drug: Placebo (for Rimonabant)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 2420
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Bridgewater, New Jersey, United States, 08807
      • Sanofi-Aventis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo (for Rimonabant) once daily.	Drug: Placebo (for Rimonabant); Tablet, oral administration
Experimental: Rimonabant; Rimonabant 20 mg once daily	Drug: Rimonabant; Tablet, oral administration; Other Names: Acomplia; SR141716

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time of progression to type 2 diabetes	Baseline to 30 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: May 12, 2006
• First Submitted That Met QC Criteria: May 12, 2006
• First Posted (Estimate): May 15, 2006

Study Record Updates

• Last Update Posted (Estimate): May 18, 2016
• Last Update Submitted That Met QC Criteria: April 19, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Impaired fasting glucose; Prediabetic state; Impaired glucose Tolerance
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Obesity Agents; Cannabinoid Receptor Modulators; Cannabinoid Receptor Antagonists; Rimonabant
• Other Study ID Numbers: EFC5107