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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Glimepiride; Metformin

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.