Phase III Study for Glimepiride + Metformin Hydrochloride (Amaryl M) Slow Release (SR)

Inclusion Criteria: * Subjects with type 2 DM diagnosed for at least 3 months but no longer than 10 years before screening; * \- BMI ≤ 40 kg/m²; * A negative pregnancy test for all females of childbearing potential Exclusion Criteria: * A history of acute metabolic complications such as diabetic ketoacidosis or hyperosmolar nonketotic coma within 3 months before screening; * Current therapy with any oral anti-diabetic drugs or previous use in the 4 weeks other than sulfonylureas or metformin (8 weeks in case of thiazolidinedione) before screening; * Concomitant treatment prohibited during the study period; * Any oral anti-diabetic drugs other than study medication * Any insulin therapy over 7 days consecutively or intermittently in order to treat acute metabolic decompensation or systemic infection during the study * Intermittent use of systemic corticosteroids or large dose of inhaled steroids * Subjects with clinically significant renal (serum creatinine level \>1.5 mg/dL in male and \>1.4 mg/dL in female) or hepatic disease (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \>2x upper limit of normal (ULN)); * Subjects with acute and severe cardiovascular disease (e.g. heart failure, myocardiac infarction, stroke etc.) * Clinically significant laboratory abnormality on screening labs or any medical condition that would affect the completion or outcome of the study in the opinion of the investigator and/or sponsor; * Pregnant or lactating females; * History of drug or alcohol abuse; * Subjects with known hypersensitivity to glimepirides, or metformin; Night-shift workers; * Treatment with any investigational product in the last 3 months before study entry; The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.