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The study design of this trial is open-label, randomized, multi-center, parallel-group study.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amaryl MEX | Experimental |
| |
| Amaryl M | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glimepiride/ Metformin | Drug | 4/1000mg once daily |
| |
| Glimepiride/ Metformin |
| Measure | Description | Time Frame |
|---|---|---|
| compliance of patients treated with once-daily or twice-daily | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose lowering effect | 24 weeks | |
| Episodes of hypoglycaemia | 24 weeks | |
| other adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sungwoo Park, professor | Kangbuk Samsung Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Handok Pharmaceuticals | Seoul | Seoul | South Korea |
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| Drug |
4/1000mg bid |
|
| 24 weeks |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C057619 | glimepiride |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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