Effect of Rimonabant and Metformin Combination on Glycemic 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 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
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The total duration per patient will be approximately 49 weeks including a 36-week double-blind treatment period.

Official Title
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A Randomized, Double Blind, Placebo Controlled Study Evaluating the Glycemic Effect of Rimonabant Added to Metformin in Patients With Type 2 Diabetes Insufficiently Controlled With Metformin Monotherapy

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Rimonabant
* Drug: Placebo (for Rimonabant)
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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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.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rimonabant<br>Rimonabant 20 mg once daily on top of metformin | Drug: Rimonabant<br>* Tablet, oral administration<br>* Other names: Acomplia;Drug: Metformin<br>* Metformin continued at stable dose as background therapy<br>|
| Placebo Comparator: Placebo<br>Placebo (for Rimonabant) once daily on top of metformin | Drug: Placebo (for Rimonabant)<br>* Tablet, oral administration<br>Drug: Metformin<br>* Metformin continued at stable dose as background therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c |  | 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in fasting plasma glucose |  | 36 weeks | 
| Change from baseline in body weight |  | 36 weeks | 
| Percent change from baseline in HDL-C and Triglycerides |  | 36 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized Controlled Trial, Metformin