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

Handok

Status and phase

Completed

Phase 4

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Glimepiride/ Metformin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01444248

HANDOK2009.02

Details and patient eligibility

About

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

Full description

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.

Enrollment

168 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.)