Compare the Compliance of Patients Treated With Once-daily (od) or Twice-daily (Bid) Glimepiride and Metformin Fixed Combination Therapy
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Glimepiride/ Metformin
Glimepiride/ Metformin
Sponsored by

About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Amaryl MEX
Eligibility 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.)
Sites / Locations
- Handok Pharmaceuticals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Amaryl MEX
Amaryl M
Arm Description
Outcomes
Primary Outcome Measures
compliance of patients treated with once-daily or twice-daily
Secondary Outcome Measures
Blood glucose lowering effect
Episodes of hypoglycaemia
other adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01444248
Brief Title
Compare the Compliance of Patients Treated With Once-daily (od) or Twice-daily (Bid) Glimepiride and Metformin Fixed Combination Therapy
Official Title
A Multi-center, Open, Randomized, Parallel-group Study to Compare the Compliance of Patients Treated With Once-daily (od) or Twice-daily (Bid) Glimepiride and Metformin Fixed Combination Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Handok Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Amaryl MEX
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amaryl MEX
Arm Type
Experimental
Arm Title
Amaryl M
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Glimepiride/ Metformin
Intervention Description
4/1000mg once daily
Intervention Type
Drug
Intervention Name(s)
Glimepiride/ Metformin
Intervention Description
4/1000mg bid
Primary Outcome Measure Information:
Title
compliance of patients treated with once-daily or twice-daily
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Blood glucose lowering effect
Time Frame
24 weeks
Title
Episodes of hypoglycaemia
Time Frame
24 weeks
Title
other adverse events
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sungwoo Park, professor
Organizational Affiliation
Kangbuk Samsung Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Handok Pharmaceuticals
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Compare the Compliance of Patients Treated With Once-daily (od) or Twice-daily (Bid) Glimepiride and Metformin Fixed Combination Therapy
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