A Glycemic Control Evaluation of Glimepiride Versus Rimonabant on Top of Metformin in Type 2 Diabetes

Study Overview
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Brief Summary
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The primary objective is to demonstrate, after 52 weeks of treatment, the non-inferiority of rimonabant 20 mg once daily (od) versus glimepiride od in reducing glycosylated haemoglobin (HbA1c) in overweight/obese patients with type 2 diabetes not adequately controlled with metformin at a stable dose (≥ 1500 mg/day) for at least 3 months. The main secondary objectives are to assess the effect of rimonabant in comparison with glimepiride on body weight and HDL-Cholesterol and the long-term safety and tolerability of rimonabant in comparison with glimepiride.

Detailed Description
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The total duration per patient will be approximately 65 weeks including a 52-week double-blind treatment period.

Official Title
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A Randomized, Double-Blind, Parallel-Group, Multicenter, Multinational Study to Assess Glycemic Control With Rimonabant in Comparison With Glimepiride Over 1 Year in Overweight/Obese Type2 Diabetic Patients Not Adequately Controlled With Metformin

Conditions
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Diabetes Mellitus, Type 2

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with legal age Body Mass Index >27kg/m2 Type 2 diabetes as defined by World Health Organization (WHO) criteria, treated with metformin for at least 6 months and with a stable dose of metformin >=1500 mg/day for at least three months HbA1c >=7% and <=9% at screening visit Exclusion Criteria: Weight loss > 5 kg within three months prior to screening Presence of any clinically significant endocrine disease according to the Investigator Presence of type 1 diabetes Presence or history of cancer within the past 5 years with the exception of adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer Previous participation in a clinical study with rimonabant Absence of effective medical contraceptive method for females of childbearing potential Within 3 months prior to screening visit: use of oral antidiabetic drugs (other than metformin) and/or insulin, of anti-obesity drugs or other drugs for weight reduction Within 2 months 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 Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study, including uncontrolled serious psychiatric illness 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>|
| Active Comparator: Glimepiride<br>Glimepiride from 1 mg up to 6 mg once daily on top of metformin | Drug: Glimepiride<br>* Tablet, oral administration<br>* Other names: Amaryl;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 glycemic measure HbA1c |  | 52 weeks (1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change from baseline in body weight |  | 52 weeks | 
| Relative change from baseline in HDL-C |  | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Metformin