Status:
COMPLETED
Compare the Compliance of Patients Treated With Once-daily (od) or Twice-daily (Bid) Glimepiride and Metformin Fixed Combination Therapy
Lead Sponsor:
Handok Inc.
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The study design of this trial is open-label, randomized, multi-center, parallel-group study.
Detailed 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 predisposin...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT01444248
Start Date
August 1 2010
End Date
May 1 2012
Last Update
August 23 2012
Active Locations (1)
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1
Handok Pharmaceuticals
Seoul, Seoul, South Korea