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

Study Overview
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Brief Summary
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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
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The total duration per patient will be approximately 69 weeks including a 52-week double-blind treatment period.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of SR141716 in Obese Type 2 Diabetic Patients on Monotherapy Inadequately Controlled With Oral Anti-diabetic Drug

Conditions
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Obesity, Diabetes Mellitus Type 2

Intervention / Treatment
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* Drug: Rimonabant
* Drug: Placebo (for Rimonabant)
* Drug: Anti-diabetic monotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rimonabant<br>Rimonabant 20 mg once daily | Drug: Rimonabant<br>* Tablet, oral administration<br>* Other names: Acomplia;Drug: Anti-diabetic monotherapy<br>* Previous treatment with Sulfonylurea or α-glucosidase inhibitor continued at stable dose during the study period<br>|
| Placebo Comparator: Placebo<br>Placebo (for Rimonabant) once daily | Drug: Placebo (for Rimonabant)<br>* Tablet, oral administration<br>Drug: Anti-diabetic monotherapy<br>* Previous treatment with Sulfonylurea or α-glucosidase inhibitor continued at stable dose during the study period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change from baseline in HbA1C |  | Baseline to week 52 | 
| Relative change from baseline in in body weight |  | Baseline to week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change from baseline in Fasting Plasma Glucose |  | Baseline to week 52 | 
| Absolute change from baseline in waist circumference |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obese, diabetes, cannabinoid-1 receptor