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

Prediabetic State Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00325650
• Other study ID #: EFC5107
• Status: Terminated
• Phase: Phase 3
• First received: May 12, 2006
• Last updated: June 12, 2009
• Start date: May 2006
• Est. completion date: March 2009

Study information

• Verified date: June 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2420
• Est. completion date: March 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glucose Intolerance
• Prediabetic State

Intervention

Drug:
• rimonabant (SR141716)
oral administration once daily
• placebo
oral administration once daily

Locations

Country	Name	City	State
United States	Sanofi-Aventis	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of progression to type 2 diabetes		study period	No
Secondary	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		study period	No