Phase III Study for Glimepiride + Metformin Hydrochloride (Amaryl M) Slow Release (SR)
Status:
Completed
Trial end date:
2007-07-01
Target enrollment:
Participant gender:
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