Japanese Study With Rimonabant in Obese Type 2 Diabetic Patients on Diet and Exercise

NCT ID: NCT00478972

Last Updated: 2016-06-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 321 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2009-01-31

Brief Summary

The primary objective of this study is to assess the efficacy of Rimonabant (SR141716) compared to placebo on change in HbA1c and on relative change in body weight over 36 weeks in obese type 2 diabetic patients inadequately controlled with diet and exercise alone.

The secondary objectives are:

• To evaluate the effect of Rimonabant compared to placebo on other parameters related to the glucose control, waist circumference, Body Mass Index and metabolic parameters;
• To evaluate the safety and tolerability of Rimonabant compared to placebo;
• To evaluate the pharmacokinetics of Rimonabant.

Detailed Description

The total duration per patient will be approximately 53 weeks including a 36-week double-blind treatment period.

Conditions

Obesity; Diabetes Mellitus Type 2

Study Design

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

Study Groups

Rimonabant

Rimonabant 20 mg once daily in addition to diet and exercise

Group Type: EXPERIMENTAL

Rimonabant

Intervention Type: DRUG

Tablet, oral administration

Diet and exercise

Intervention Type: OTHER

Target daily caloric intake: Ideal body weight × 25 kcal

Placebo

Placebo (for Rimonabant) once daily in addition to diet and exercise

Group Type: PLACEBO_COMPARATOR

placebo (for Rimonabant)

Intervention Type: DRUG

Tablet, oral administration

Diet and exercise

Intervention Type: OTHER

Target daily caloric intake: Ideal body weight × 25 kcal

Interventions

Rimonabant

Tablet, oral administration

Intervention Type: DRUG

placebo (for Rimonabant)

Tablet, oral administration

Intervention Type: DRUG

Diet and exercise

Target daily caloric intake: Ideal body weight × 25 kcal

Intervention Type: OTHER

Other Intervention Names

SR141716; Acomplia

Eligibility Criteria

Inclusion Criteria

• Type 2 Diabetes Mellitus patients inadequately treated with diet and exercise alone (not drug treated)
• HbA1C ≥ 7.0 % and ≤ 10.0 %
• Body Mass Index ≥ 25 kg/m²

Exclusion Criteria

• Type 1 diabetes
• Within 12 weeks prior to screening visit: use of oral antidiabetic drugs and/or insulin, of anti-obesity drugs or other drugs for weight reduction
• Within 4 weeks prior to screening visit: administration of systemic long-acting corticosteroids or prolonged use (more than one week) of other systemic corticosteroids, change in lipid lowering treatment
• Secondary obesity
• Primary hyperlipidemia
• Positive serum pregnancy test in females of childbearing potential

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 20 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 Administrative Office

Tokyo, , Japan

Countries

Japan

Other Identifiers

EFC6648

Identifier Type: -

Identifier Source: org_study_id