Status:
TERMINATED
A Glycemic Control Evaluation of Glimepiride Versus Rimonabant on Top of Metformin in Type 2 Diabetes
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 over...
Detailed Description
The total duration per patient will be approximately 65 weeks including a 52-week double-blind treatment period.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
508 Patients enrolled
Trial Details
Trial ID
NCT00449605
Start Date
March 1 2007
End Date
March 1 2009
Last Update
May 16 2016
Active Locations (15)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Santiago, Chile
3
Sanofi-aventis adminsitrative office
Santiago, Chile
4
Sanofi-Aventis Administrative Office
Hørsholm, Denmark