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

Condition(s) targeted: Obesity; Diabetes Mellitus Type 2

Intervention: rimonabant (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Sanofi-Aventis

Overall contact:
Public registry ICD, Email: GV-Contact-us@sanofi-aventis.com

The primary objective of this study is to assess the efficacy of SR141716 (rimonabant) 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 SR141716 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 SR141716 compared to placebo

• To evaluate the pharmacokinetics of SR141716

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 on Diet and Exercise Alone

Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome:

Absolute change in HbA1C from baseline to Week 36

Relative change in body weight from baseline to Week 36

Secondary outcome:

Absolute change, in Fasting Plasma Glucose and in waist circumference from baseline to Week 36

Relative change in Triglycerides and HDL-cholesterol from baseline to Week 36

Safety: adverse events, laboratory tests, vital signs

Minimum age: 20 Years. Gender(s): Both.

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.

Public registry ICD, Email: GV-Contact-us@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Tokyo, Japan; Recruiting
Email: GV-Contact-us@sanofi-aventis.com

Starting date: May 2007
Last updated: June 19, 2007