Study of Rimonabant/Metformin Combinations to Investigate Diabetes (Blood Sugar) Control in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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The primary objective of the study is to demonstrate superiority of rimonabant/metformin combinations in Glycosylated Hemoglobin 1c (A1C) reduction over the corresponding single agent metformin and over rimonabant alone in patients with type 2 diabetes mellitus at 9 months. The secondary objective is to investigate the effects of rimonabant/metformin combinations for reducing fasted plasma glucose, body weight and triglycerides, and raising High Density Lipoprotein Cholesterol (HDL-C) in comparison with metformin at 9 months. Another objective is to evaluate the safety of rimonabant in combination with metformin over a period of up to 52 weeks.

Detailed Description
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The duration per patient is up to 65 weeks: 1 - 2 weeks screening, up to 52 weeks double blind treatment, and 75 days post last dose. This study will end for all patients when the last patient has been treated for at least 9 months.

Official Title
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A Multicenter, Double Blind, Placebo Controlled Randomized Study of the Efficacy and Safety of Two Rimonabant/Metformin Combinations for Reducing A1C in the Treatment of Patients With Type 2 Diabetes Mellitus Who Are Not on Current Drug Therapy.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Rimonabant
* Drug: Metformin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of type 2 diabetes mellitus diagnosed prior to the screening visit 1 (ADA criteria) Patients must not have used any oral or injectable glucose lowering medication at least 12 weeks prior to the screening visit to establish a stable, comparable baseline A1C assessment in all patients A1C ≥7.0 % and ≤10.0 % Fasted plasma glucose at screening visit ≤260 mg/dL (14.44 mmol/L) Exclusion Criteria: Treatment with any anti-diabetic oral agent, or injectable antidiabetic agent within 12 weeks prior to screening visit In the 3 months prior to the screening visit, use of any anti-obesity agent or drugs for weight loss, or administration of systemic corticosteroids for more than 7 days 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 Presence or history of cancer within the past five years Pregnant or breast-feeding women, or women of childbearing potential not protected by effective method of birth control 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: 18 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 |
| --- | --- |
| Active Comparator: Arm 1<br>Metformin 500mg twice daily (bid) + placebo | Drug: Metformin<br>* Tablet, oral administration<br>Drug: placebo<br>* Tablet, oral administration<br>|
| Active Comparator: Arm 2<br>Metformin 1000mg bid + placebo | Drug: Metformin<br>* Tablet, oral administration<br>Drug: placebo<br>* Tablet, oral administration<br>|
| Active Comparator: Arm 3<br>Rimonabant 20mg once daily (od) + placebo | Drug: Rimonabant<br>* Tablet, oral administration<br>* Other names: Acomplia;Drug: placebo<br>* Tablet, oral administration<br>|
| Experimental: Arm 4<br>Rimonabant 10mg bid (from week 2) in combination with metformin 500mg bid | Drug: Rimonabant<br>* Tablet, oral administration<br>* Other names: Acomplia;Drug: Metformin<br>* Tablet, oral administration<br>|
| Experimental: Arm 5<br>Rimonabant 10mg bid (from week 2) in combination with metformin 1000mg bid | Drug: Rimonabant<br>* Tablet, oral administration<br>* Other names: Acomplia;Drug: Metformin<br>* Tablet, oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in A1C |  | at 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in fasting plasma glucose |  | at 9 months | 
| Change from baseline in body weight |  | at 9 months | 
| Percent change from baseline in triglycerides |  | at 9 months | 
| Percent change from baseline in HDL-C |  | at 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rimonabant/metformin combination