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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01444248
First received: September 21, 2011
Last updated: August 21, 2012
Last verified: August 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: Glimepiride/ Metformin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Handok Pharmaceuticals Co., Ltd.:

Primary Outcome Measures:
  • compliance of patients treated with once-daily or twice-daily [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood glucose lowering effect [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Episodes of hypoglycaemia [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • other adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 168
Study Start Date: August 2010
Study Completion Date: May 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Amaryl MEX Drug: Glimepiride/ Metformin
4/1000mg once daily
Active Comparator: Amaryl M Drug: Glimepiride/ Metformin
4/1000mg bid

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01444248

Locations
Korea, Republic of
Handok Pharmaceuticals
Seoul, Korea, Republic of
Sponsors and Collaborators
Handok Pharmaceuticals Co., Ltd.
Investigators
Principal Investigator: Sungwoo Park, professor Kangbuk Samsung Medical center
  More Information

No publications provided

Responsible Party: Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT01444248     History of Changes
Other Study ID Numbers: HANDOK2009.02
Study First Received: September 21, 2011
Last Updated: August 21, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Handok Pharmaceuticals Co., Ltd.:
Amaryl MEX

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Metformin
Hypoglycemic Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013