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

NCT ID: NCT01444248

Last Updated: 2012-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus

Keywords

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Amaryl MEX

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Amaryl MEX

Group Type EXPERIMENTAL

Glimepiride/ Metformin

Intervention Type DRUG

4/1000mg once daily

Amaryl M

Group Type ACTIVE_COMPARATOR

Glimepiride/ Metformin

Intervention Type DRUG

4/1000mg bid

Interventions

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Glimepiride/ Metformin

4/1000mg once daily

Intervention Type DRUG

Glimepiride/ Metformin

4/1000mg bid

Intervention Type DRUG

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Handok Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sungwoo Park, professor

Role: PRINCIPAL_INVESTIGATOR

Kangbuk Samsung Hospital

Locations

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Handok Pharmaceuticals

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HANDOK2009.02

Identifier Type: -

Identifier Source: org_study_id