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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

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Amaryl MEX

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.)

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

NCT ID

NCT01444248

First Posted

September 21, 2011

Last Updated

August 21, 2012

Sponsor

Handok Inc.

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

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

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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