Japanese Study With Rimonabant in Obese Type 2 Diabetic Patients With Oral Anti-diabetic Drug

Phase 3

Terminated

Interventions: Drug: Rimonabant
Drug: Placebo (for Rimonabant)
Drug: Anti-diabetic monotherapy

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 52 weeks in obese type 2 diabetic patients on monotherapy inadequately controlled with oral anti-diabetic drug (sulfonylurea or α-glucosidase inhibitor).

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 69 weeks including a 52-week double-blind treatment period.

Recruitment & Eligibility

Inclusion Criteria

Type 2 Diabetes Mellitus patients on monotherapy with oral anti-diabetic drug (sulfonylurea or α-glucosidase inhibitor)
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 (other than a sulfonylurea or alpha-glucosidase inhibitor) 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.

Arm && Interventions

Group	Intervention	Description
Rimonabant	Rimonabant	Rimonabant 20 mg once daily
Rimonabant	Anti-diabetic monotherapy	Rimonabant 20 mg once daily
Placebo	Placebo (for Rimonabant)	Placebo (for Rimonabant) once daily
Placebo	Anti-diabetic monotherapy	Placebo (for Rimonabant) once daily

Primary Outcome Measures

Name	Time	Method
Relative change from baseline in in body weight	Baseline to week 52
Absolute change from baseline in HbA1C	Baseline to week 52

Secondary Outcome Measures

Name	Time	Method
Absolute change from baseline in Fasting Plasma Glucose	Baseline to week 52
Relative change from baseline in Triglycerides and HDL-cholesterol	Baseline to week 52
Safety: overview of adverse events	Baseline to Week 56
Absolute change from baseline in waist circumference	Baseline to week 52