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

Summary

Primary: To show the equivalence in terms of efficacy glycated hemoglobin (HbA1c) of glimepiride/metformin slow-release combination tablet (Amaryl M SR 2/500) once daily compared with fixed-dose glimepiride/metformin combination tablet (Amaryl M 1/250) twice a day on HbA1c in patients with type 2 Diabetes Mellitus (DM) Secondary: To compare the following parameters in two treatment arm * Efficacy; Fasting Plasma Glucose (FPG) and Post-prandial two hours plasma glucose (PP2h) * Response rates in terms of HbA1c, FPG * Patient compliance Safety: * episodes of hypoglycemia * adverse events * laboratory values including hematology blood chemistry and urinalysis * vital sign and physical examination

Timeline

Start

2006-08

Primary completion

—

Completion

2007-07

Drugs

Indications