Comparative Study of HOE490 O (Glimepiride and Metformin) Compared With Placebo on Top of Glimepiride
NCT ID: NCT00924573
Last Updated: 2011-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
189 participants
INTERVENTIONAL
2009-05-31
2010-03-31
Brief Summary
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Secondary objectives of this study is to evaluate the safety of HOE490 O (glimepiride/metformin) compared with placebo on top of glimepiride as well as other efficacy parameters
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Metformin on top of glimepiride
Twice a day with 2-6 mg of daily dose for glimepiride and 500-750mg of daily dose for metformin for 24 weeks
Metformin
oral administration
Glimepiride (HOE490)
oral administration
2
Placebo on top of glimepiride
Twice a day with 2-6 mg of daily dose for glimepiride and 2-3 tablets of placebo for 24 weeks
placebo
oral administration
Glimepiride (HOE490)
oral administration
Interventions
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Metformin
oral administration
placebo
oral administration
Glimepiride (HOE490)
oral administration
Eligibility Criteria
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Inclusion Criteria
* Patients who gave informed consent to participate in the study
Exclusion Criteria
* 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.
20 Years
74 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Kaku Kohei, Professor
Role: PRINCIPAL_INVESTIGATOR
Kawasaki Medical University
Locations
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Sanofi-Aventis Administrative Office
Tokyo, , Japan
Countries
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Other Identifiers
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HOE490/4045
Identifier Type: -
Identifier Source: secondary_id
EFC10846
Identifier Type: -
Identifier Source: org_study_id