Status:
WITHDRAWN
Study of Rimonabant/Metformin Combinations to Investigate Diabetes (Blood Sugar) 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 demonstrate superiority of rimonabant/metformin combinations in Glycosylated Hemoglobin 1c (A1C) reduction over the corresponding single agent metformin and ov...
Detailed Description
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 bee...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00754689
Start Date
September 1 2008
End Date
November 1 2008
Last Update
May 17 2016
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807