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

Obesity Clinical Trial

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Fixed Single-dose Regimen, Multicenter Study to Assess the Efficacy and Safety of SR141716 in Obese Type 2 Diabetic Patients Inadequately Controlled With Diet and Exercise Alone

Status Terminated

Clinical Trial 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.

Clinical Trial Description

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Obesity

• NCT number: NCT00478972
• Study type: Interventional
• Source: Sanofi
• Status: Terminated
• Phase: Phase 3
• Start date: April 2007
• Completion date: January 2009