Status:
COMPLETED
Comparative Study of HOE490 O (Glimepiride and Metformin) Compared With Placebo on Top of Glimepiride
Lead Sponsor:
Sanofi
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
20-74 years
Phase:
PHASE3
Brief Summary
Primary objective of this study is to confirm the efficacy of HOE490 O (glimepiride/metformin) compared with placebo on top of glimepiride in HbA1c change. Secondary objectives of this study is to ev...
Detailed Description
Patients treated with 2-6mg/day of glimepiride will be recruited. The study period consists of screening phase of 6 weeks and double-blinded phase of 24 weeks.
Eligibility Criteria
Inclusion
- Type 2 Diabetes Mellitus patients treated with constant dose of glimepiride on top of diet and exercise
- Patients who gave informed consent to participate in the study
Exclusion
- Patients with HbA1c of \< 7.0 % and \> 11.0 %
- Patients with any following laboratory test abnormality :
- ALT and/or AST: \> 3 X ULN
- Neutrophils: \< 1,000/mm3 and/or platelets \< 100,000/mm3
- Hemoglobin: \<11 g/dL
- Creatinine: \>= 1.3 mg/dL in case of male or \>= 1.0 mg/dL in case of female
- 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 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT00924573
Start Date
May 1 2009
End Date
March 1 2010
Last Update
August 31 2011
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Tokyo, Japan