Comparative Study of HOE490 O (Glimepiride and Metformin) Compared With Placebo on Top of Glimepiride
Overview[ - collapse ][ - ]
Purpose | 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 |
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Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Metformin Drug: placebo Drug: Glimepiride (HOE490) |
Phase | Phase 3 |
Sponsor | Sanofi |
Responsible Party | Sanofi |
ClinicalTrials.gov Identifier | NCT00924573 |
First Received | June 18, 2009 |
Last Updated | August 30, 2011 |
Last verified | August 2011 |
Tracking Information[ + expand ][ + ]
First Received Date | June 18, 2009 |
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Last Updated Date | August 30, 2011 |
Start Date | May 2009 |
Estimated Primary Completion Date | March 2010 |
Current Primary Outcome Measures | Changes in HbA1c from baseline [Time Frame: 24 weeks] [Designated as safety issue: No] |
Current Secondary Outcome Measures | Change in the ratio patients with < 7.0% of HbA1c [Time Frame: 24 weeks] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
Brief Title | Comparative Study of HOE490 O (Glimepiride and Metformin) Compared With Placebo on Top of Glimepiride |
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Official Title | 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 |
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 evaluate the safety of HOE490 O (glimepiride/metformin) compared with placebo on top of glimepiride as well as other efficacy parameters |
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. |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Metformin oral administration Drug: placebo oral administration Drug: Glimepiride (HOE490) oral administration |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 189 |
Estimated Completion Date | March 2010 |
Estimated Primary Completion Date | March 2010 |
Eligibility Criteria | 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. |
Gender | Both |
Ages | 20 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Japan |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00924573 |
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Other Study ID Numbers | EFC10846 |
Has Data Monitoring Committee | No |
Information Provided By | Sanofi |
Study Sponsor | Sanofi |
Collaborators | Not Provided |
Investigators | Principal Investigator: Kaku Kohei, Professor Kawasaki Medical University |
Verification Date | August 2011 |
Locations[ + expand ][ + ]
Sanofi-Aventis Administrative Office | Tokyo, Japan |
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