Rimonabant In Prediabetic Subjects To Delay Onset Of Type 2 Diabetes

NCT ID: NCT00325650

Last Updated: 2016-05-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 2420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2009-03-31

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.

Detailed Description

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

Conditions

Prediabetic State

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Rimonabant

Rimonabant 20 mg once daily

Group Type: EXPERIMENTAL

Rimonabant

Intervention Type: DRUG

Tablet, oral administration

Placebo

Placebo (for Rimonabant) once daily.

Group Type: PLACEBO_COMPARATOR

Placebo (for Rimonabant)

Intervention Type: DRUG

Tablet, oral administration

Interventions

Rimonabant

Tablet, oral administration

Intervention Type: DRUG

Placebo (for Rimonabant)

Tablet, oral administration

Intervention Type: DRUG

Other Intervention Names

SR141716; Acomplia

Eligibility 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;

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Bridgewater, New Jersey, United States

Countries

United States

Other Identifiers

EFC5107

Identifier Type: -

Identifier Source: org_study_id