Status:
TERMINATED
Effect of Rimonabant and Metformin Combination on Glycemic Control in Patients With Type 2 Diabetes
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
The total duration per patient will be approximately 49 weeks including a 36-week double-blind treatment period.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
403 Patients enrolled
Trial Details
Trial ID
NCT00690456
Start Date
May 1 2008
End Date
February 1 2009
Last Update
May 18 2016
Active Locations (13)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Jakarta, Indonesia
3
Sanofi-Aventis Administrative Office
Vilnius, Lithuania
4
Sanofi-Aventis Administrative Office
Kuala Lumpur, Malaysia