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

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 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.

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

Official Title
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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

Conditions
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Obesity, Diabetes Mellitus Type 2

Intervention / Treatment
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* Drug: Rimonabant
* Drug: placebo (for Rimonabant)
* Other: Diet and exercise


Participation Criteria
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Eligibility Criteria
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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.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rimonabant<br>Rimonabant 20 mg once daily in addition to diet and exercise | Drug: Rimonabant<br>* Tablet, oral administration<br>* Other names: Acomplia;Other: Diet and exercise<br>* Target daily caloric intake: Ideal body weight × 25 kcal<br>|
| Placebo Comparator: Placebo<br>Placebo (for Rimonabant) once daily in addition to diet and exercise | Drug: placebo (for Rimonabant)<br>* Tablet, oral administration<br>Other: Diet and exercise<br>* Target daily caloric intake: Ideal body weight × 25 kcal<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 36 | 
| Relative change from baseline in body weight |  | Baseline to Week 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change from baseline in Fasting Plasma Glucose |  | Baseline to Week 36 | 
| Absolute change from baseline in waist circumference |  | Baseline to Week 36 | 
| Relative change from baseline in Triglycerides and HDL-cholesterol |  | Baseline to Week 36 | 
| Safety: Overview of adverse events |  | Baseline to Week 47 | 

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