Compare the Compliance of Patients Treated With Once-daily (od) or Twice-daily (Bid) Glimepiride and Metformin Fixed Combination Therapy

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The study design of this trial is open-label, randomized, multi-center, parallel-group study.

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

Details

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

Criteria

Inclusion Criteria:

• Patients aged between 18 ~ 75 years at screening

• Patients who have been diagnosed with type 2 DM for at least 3 months

• Patients who were treated with a stable dose with combination therapy of glimepiride 4mg or more and metformin 1000mg or more which can switch to Amaryl M 2/500mg bid or Amaryl Mex 2/500mg 2T od regimen.

• HbA1c ≤ 9 % at randomization

• BMI ≤ 40 kg/m2 at randomization

• Patients who would give the informed consent

• Patients who can perform SMBG and record the data on the patient's diary

• Patients who can understand and use MEMS properly

Exclusion Criteria:

• Patients with the medical history of acute metabolic complications such as diabetic ketoacidosis, hyperosmolar nonketotic coma within 3 months prior to the study participation

• Patients who are under insulin therapy at randomization

• Patients who received systemic corticosteroid agent within 4 weeks prior to the study participation

• Patients with acute, severe cardiovascular disease (e.g., heart failure, myocardial infarction, stroke, etc).

• Pregnant or lactating females

• history of drug or alcohol abuse

• Patients with known hypersensitivity to the ingredient of the study drug or drugs in sulfonylurea, sulfonamide, biguanide class

• Night-shift workers

• Patients with an experience of participating in other clinical trial within 3 months prior to the study participation

• Clinically significant laboratory abnormality on screening labs or any medical condition that would affect the completion or outcome of the study based on investigator's decision

• Patients with serum creatinine level > 1.5 mg/dl in male and > 1.4 mg/dl in female

• Patients with ALT or AST > 3x ULN

• Any conditions requiring help of others with drug administration (e.g. manual disability, serious visual defect, etc.)