Compare the Compliance of Patients Treated With Once-daily (od) or Twice-daily (Bid) Glimepiride and Metformin Fixed Combination Therapy
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The study design of this trial is open-label, randomized, multi-center, parallel-group study.
Condition or disease
Type 2 Diabetes Mellitus
Drug: Glimepiride/ Metformin
The effectiveness of treatment of a disease depends mainly on two factors: the efficacy of the treatment and the compliance of the patient with this treatment. Polymedication is one of the predisposing factors to low compliance in type 2 DM. It can be expected that a simple regimen may improve compliance. Amaryl Mex phase III trial was not designed to compare the compliance of patients with different dosing regimens of oral antidiabetic drugs. However, it was found that patients' compliance in the morning was better than in the evening, suggesting that Amaryl Mex once daily regimen may improve compliance. Pill count is the gold standard for measuring compliance, but this method provides incomplete and unreliable results. Advanced electronic monitoring device obtains details of patients' behavior during the day and over long periods.
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
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.)