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

Overview[ - collapse ][ - ]

Purpose The study design of this trial is open-label, randomized, multi-center, parallel-group study.
ConditionType 2 Diabetes Mellitus
InterventionDrug: Glimepiride/ Metformin
Drug: Glimepiride/ Metformin
PhasePhase 4
SponsorHandok Pharmaceuticals Co., Ltd.
Responsible PartyHandok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov IdentifierNCT01444248
First ReceivedSeptember 21, 2011
Last UpdatedAugust 21, 2012
Last verifiedAugust 2012

Tracking Information[ + expand ][ + ]

First Received DateSeptember 21, 2011
Last Updated DateAugust 21, 2012
Start DateAugust 2010
Estimated Primary Completion DateMay 2012
Current Primary Outcome Measurescompliance of patients treated with once-daily or twice-daily [Time Frame: 24 weeks] [Designated as safety issue: No]
Current 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]

Descriptive Information[ + expand ][ + ]

Brief TitleCompare the Compliance of Patients Treated With Once-daily (od) or Twice-daily (Bid) Glimepiride and Metformin Fixed Combination Therapy
Official TitleA 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
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.
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionType 2 Diabetes Mellitus
InterventionDrug: Glimepiride/ Metformin
4/1000mg once daily
Drug: Glimepiride/ Metformin
4/1000mg bid
Study Arm (s)
  • Experimental: Amaryl MEX
  • Active Comparator: Amaryl M

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment168
Estimated Completion DateMay 2012
Estimated Primary Completion DateDecember 2011
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.)
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesKorea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number NCT01444248
Other Study ID NumbersHANDOK2009.02
Has Data Monitoring CommitteeNo
Information Provided ByHandok Pharmaceuticals Co., Ltd.
Study SponsorHandok Pharmaceuticals Co., Ltd.
CollaboratorsNot Provided
Investigators Principal Investigator: Sungwoo Park, professor Kangbuk Samsung Medical center
Verification DateAugust 2012

Locations[ + expand ][ + ]

Handok Pharmaceuticals
Seoul, Korea, Republic of