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

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.

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.