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

Official Title: “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.”

The primary objective of the study is to demonstrate superiority of rimonabant/metformin combinations in 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 of the study is to investigate the effects of rimonabant/metformin combinations for reducing fasted plasma glucose, body weight and triglycerides, and raising HDL-C in comparison with metformin at 9 months.

Another study objective is to evaluate the safety of rimonabant in combination with metformin over a period of up to 52 weeks.

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.

Intervention(s) in this Clinical Trial

• Drug: rimonabant (SR141716)
  • oral administration
• Drug: metformin
  • oral administration
• Drug: placebo
  • oral administration

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Arm 1
  • metformin 500mg bid + placebo
• Active Comparator: Arm 2
  • metformin 1000mg bid + placebo
• Active Comparator: Arm 3
  • rimonabant 20mg od + placebo
• Experimental: Arm 4
  • rimonabant 10mg bid (from week 2) in combination with metformin 500mg bid
• Experimental: Arm 5
  • rimonabant 10mg bid (from week 2) in combination with metformin 1000mg bid

Primary Measures

• Change from baseline in A1C
  • Time Frame: at 9 months
    Safety Issue?: No

Secondary Measures

• Change from baseline in fasting plasma glucose
  • Time Frame: at 9 months
    Safety Issue?: No
• Change from baseline in body weight
  • Time Frame: at 9 months
    Safety Issue?: No
• Percent change from baseline in TG
  • Time Frame: at 9 months
    Safety Issue?: No
• Percent change from baseline in HDL-C
  • Time Frame: at 9 months
    Safety Issue?: No

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.

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 Investigator: Sanofi-Aventis Industry

Overall Clinical Trial Officials and Contacts

ICD CSD Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00754689

Study ID Number: EFC10231

ClinicalTrials.gov Identifier: NCT00754689

Health Authority: United States: Food and Drug Administration