NCT00437554

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

A 16-Week Controlled, Double Blind, Double Dummy, Randomized, Two Arm Parallel-Group Study to Compare the Efficacy and Safety of Amaryl M 1/250 mg b.i.d vs. Amaryl M SR 2/500 mg od. in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 188 (estimated)
• Sponsor: Handok Inc. · Industry
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Glimepiride

Timeline

• Start date: 2006-08-01
• Completion: 2007-07-01
• First posted: 2007-02-21
• Last updated: 2007-11-29

Locations

1 site across 1 country: South Korea