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. |
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Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Glimepiride/ Metformin Drug: Glimepiride/ Metformin |
Phase | Phase 4 |
Sponsor | Handok Pharmaceuticals Co., Ltd. |
Responsible Party | Handok Pharmaceuticals Co., Ltd. |
ClinicalTrials.gov Identifier | NCT01444248 |
First Received | September 21, 2011 |
Last Updated | August 21, 2012 |
Last verified | August 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | September 21, 2011 |
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Last Updated Date | August 21, 2012 |
Start Date | August 2010 |
Estimated Primary Completion Date | May 2012 |
Current Primary Outcome Measures | compliance of patients treated with once-daily or twice-daily [Time Frame: 24 weeks] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Compare the Compliance of Patients Treated With Once-daily (od) or Twice-daily (Bid) Glimepiride and Metformin Fixed Combination Therapy |
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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 |
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 Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Glimepiride/ Metformin 4/1000mg once daily Drug: Glimepiride/ Metformin 4/1000mg bid |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 168 |
Estimated Completion Date | May 2012 |
Estimated Primary Completion Date | December 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.) |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Korea, Republic of |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01444248 |
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Other Study ID Numbers | HANDOK2009.02 |
Has Data Monitoring Committee | No |
Information Provided By | Handok Pharmaceuticals Co., Ltd. |
Study Sponsor | Handok Pharmaceuticals Co., Ltd. |
Collaborators | Not Provided |
Investigators | Principal Investigator: Sungwoo Park, professor Kangbuk Samsung Medical center |
Verification Date | August 2012 |
Locations[ + expand ][ + ]
Handok Pharmaceuticals | Seoul, Korea, Republic of |
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