Study Comparing Efficacy and Safety of Amaryl M and Metformin Uptitraion to Type 2 DM

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to compare the efficacy and safety of early combination therapy with Amaryl M with that of uptitration of metformin monotherapy in patients with type 2 DM inadequately controlled by prior monotherapy with metformin.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Handok Inc.; Handok Pharmaceuticals Co., Ltd.
• Treatments: Glimepiride; Metformin

Criteria

Inclusion Criteria:

• Ages 30 to 75 at the time of screening visit

• Subjects with type 2 DM diagnosed for at least 3 months before screening

• Subjects with type 2 DM treated with monotherapy of 500mg ≤ metformin ≤ 1000mg for at lest 4 weeks prior to screening

• HbA1c ≥ 7.0% but ≤ 10.0% at the time of screening visit

• 21 kg/m2 ≤ BMI ≤ 40 kg/m2

• A negative pregnancy test for all females of childbearing potential

• Provision of signed and dated informed consent prior to any study procedures

• Ability and willingness to perform SMBG and record the data on the subject's diary

Exclusion Criteria:

• A history of acute metabolic complications such as diabetic ketoacidosis or hyperosmolar nonketotic coma within 3 months before screening

• Current therapy with anti-hyperglycemic agents (except metformin) use in the 4 weeks (8 weeks in case of thiazolidinedione) before screening

• Concomitant treatment prohibited during the study period

• Any oral hypoglycemic agent other than glimepiride, metformin HCl, and fixed-dose combination of glimepiride and metformin HCl

• 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 (ALT and AST > 2x ULN)

• 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 who have a history of noncompliance with regards to follow-up medical care

• Subjects with known hypersensitivity to glimepiride, metformin HCL

• Night-shift workers

• Treatment with any investigational product in the last 3 months before study entry

• Others; subjects who have participated in this study