- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00924573
Comparative Study of HOE490 O (Glimepiride and Metformin) Compared With Placebo on Top of Glimepiride
Double-blinded Comparative Study to Investigate the Efficacy and Safety of HOE490 O (Glimepiride and Metformin) Compared With Placebo on Top of Glimepiride in Patients With T2DM Inadequately Treated With Constant Dose of Glimepiride
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 evaluate the safety of HOE490 O (glimepiride/metformin) compared with placebo on top of glimepiride as well as other efficacy parameters
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Tokyo, Japan
- Sanofi-Aventis Administrative Office
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 |
oral administration
oral administration
|
Placebo Comparator: 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 |
oral administration
oral administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in HbA1c from baseline
Time Frame: 24 weeks
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in the ratio patients with < 7.0% of HbA1c
Time Frame: 24 weeks
|
24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kaku Kohei, Professor, Kawasaki Medical University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EFC10846
- HOE490/4045
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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