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

• ClinicalTrials.gov Identifier: NCT00325650
• Recruitment Status: Terminated
• First Posted: May 15, 2006
• Last Update Posted: May 18, 2016
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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
• Other Study ID Numbers: EFC5107
• First Posted: May 15, 2006
• 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:

Prediabetic State; Glucose Metabolism Disorders; Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Rimonabant; Anti-Obesity Agents; Cannabinoid Receptor Antagonists; Cannabinoid Receptor Modulators; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs