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

Phase 3TerminatedNCT00478972

Sanofi321 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

321

Conditions

Obesity Diabetes Mellitus Type 2

Interventions

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.