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

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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Glimepiride/ Metformin; Drug: Glimepiride/ Metformin

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.

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Handok Pharmaceuticals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Amaryl MEX	Drug: Glimepiride/ Metformin; 4/1000mg once daily; Drug: Glimepiride/ Metformin; 4/1000mg bid
ACTIVE_COMPARATOR: Amaryl M	Drug: Glimepiride/ Metformin; 4/1000mg once daily; Drug: Glimepiride/ Metformin; 4/1000mg bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
compliance of patients treated with once-daily or twice-daily	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Blood glucose lowering effect	24 weeks
Episodes of hypoglycaemia	24 weeks
other adverse events	24 weeks

Collaborators and Investigators

• Sponsor: Handok Inc.
• Investigators: Principal Investigator: Sungwoo Park, professor, Kangbuk Samsung Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): May 1, 2012

Study Registration Dates

• First Submitted: September 21, 2011
• First Submitted That Met QC Criteria: September 29, 2011
• First Posted (ESTIMATE): September 30, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): August 23, 2012
• Last Update Submitted That Met QC Criteria: August 21, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Amaryl MEX
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Immunosuppressive Agents; Immunologic Factors; Metformin; Glimepiride
• Other Study ID Numbers: HANDOK2009.02