Effect of Rimonabant and Metformin Combination on Glycemic Control in Patients With Type 2 Diabetes

Phase 3

Terminated

Interventions: Drug: Placebo (for Rimonabant)
Drug: Rimonabant
Drug: Metformin

Brief Summary: The primary objective of the study is to determine the effect of rimonabant 20 mg daily when added to ongoing metformin therapy on glycemic control (HbA1c) over a 36 week period in patients with type 2 diabetes.

Secondary objectives include evaluation of other markers of glycemic control, lipid profile, body weight, and abdominal obesity. Also, the trial will study the safety of rimonabant when added to metformin over a period of 47 weeks.

Detailed Description: The total duration per patient will be approximately 49 weeks including a 36-week double-blind treatment period.

Recruitment & Eligibility

Inclusion Criteria

History of type 2 diabetes
HbA1c between 7% to 10% at screening visit
Treatment with metformin only with a fixed and stable dose of 1500 mg/day or more for at least the past 3 months prior to screening visit

Exclusion Criteria

Within 3 months prior to screening visit: change in lipid modifying agent, administration of systemic corticosteroids for more than 10 days, use of any anti-obesity agent or drugs for weight loss
Weight loss of more than 5 kg within 3 months prior to screening
Administration of other investigational drugs within 30 days prior to screening visit
Prior exposure to type 1 cannabinoid receptor (CB1) antagonists including rimonabant
Presence or history of cancer within the past five years
Pregnant or breast-feeding women
Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders.

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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo (for Rimonabant)	Placebo (for Rimonabant) once daily on top of metformin
Placebo	Metformin	Placebo (for Rimonabant) once daily on top of metformin
Rimonabant	Rimonabant	Rimonabant 20 mg once daily on top of metformin
Rimonabant	Metformin	Rimonabant 20 mg once daily on top of metformin

Primary Outcome Measures

Name	Time	Method
Change from baseline in HbA1c	36 weeks

Secondary Outcome Measures

Name	Time	Method
Percent change from baseline in HDL-C and Triglycerides	36 weeks
Change from baseline in fasting plasma glucose	36 weeks
Change from baseline in body weight	36 weeks