Comparative Study of HOE490 O (Glimepiride and Metformin) Compared With Placebo on Top of Glimepiride

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Metformin; Drug: placebo; Drug: Glimepiride (HOE490)

• Registration Number: NCT00924573
• Lead Sponsor: Sanofi

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-18
• Study First Submitted QC: 2009-06-18
• Study First Posted: 2009-06-19
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-30
• Last Update Posted: 2011-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Metformin	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
1	Glimepiride (HOE490)	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
2	placebo	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
2	Glimepiride (HOE490)	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

Primary Outcome Measures

Name	Time	Method
Changes in HbA1c from baseline	24 weeks

Secondary Outcome Measures

Name	Time	Method
Change in the ratio patients with < 7.0% of HbA1c	24 weeks

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇯🇵 Tokyo, Japan