Official Title: “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”

The primary objective is to demonstrate, after 52 weeks of treatment, the non-inferiority of rimonabant 20 mg od versus glimepiride od in reducing 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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: August 2009

Intervention(s) in this Clinical Trial

• Drug: rimonabant (SR141716)
  • on top of metformin
• Drug: glimepiride
  • on top of metformin

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Change from baseline in glycemic measure HbA1c
  • Time Frame: 52 weeks (1 year)
    Safety Issue?: No

Secondary Measures

• Absolute change from baseline in body weight and relative change from baseline in HDL-Cholesterol
  • Time Frame: 1 year
    Safety Issue?: No

Inclusion Criteria:

• Patients with legal age
• Body Mass Index >27kg/m2
• Type 2 diabetes as defined by 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

ICD Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00449605

Study ID Number: EFC10007

ClinicalTrials.gov Identifier: NCT00449605

Health Authority: United States: Food and Drug Administration