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This trial is to evaluate the efficacy and safety of CWP-0403 compared to Sitagliptin by proving non-inferiority in patients with type 2 Diabetes Mellitus insufficiently controlled with metformin alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin | Active Comparator | Sitagliptin 100mg |
|
| CWP-0403 | Experimental | CWP-0403 100mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anagliptin | Drug | Anagliptin 100mg, tablet, twice a day (BID) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Change in HbA1c from baseline to week24. | 0wk, 8wk, 16wk, 24wk |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects achieving HbA1c<7% at week24 | 0wk, 8wk, 16wk, 24wk | |
| The proportion of subjects achieving HbA1c<6.5% at week24 | 0wk, 8wk, 16wk, 24wk | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kangbuk Samsung Hospital | Seoul | South Korea |
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| Sitagliptin |
| Drug |
Sitagliptin 100mg, tablet, once a day (QD) |
|
| The change from baseline to week 24: Fasting plasma glucose |
| 0wk, 24wk |
| change from baseline to week 24: Fasting serum insulin | 0wk, 24 wk |
| change from baseline to week 24 in Fasting serum pro-insulin | 0wk, 24wk |
| change from baseline to week 24 in Fasting serum c-peptide | 0wk, 24wk |
| change from baseline to week 24 in HOMA-β | 0wk, 24 wk |
| change from baseline to week 24 in HOMA-IR | 0wk, 24 wk |
| 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 |
|---|---|
| C583175 | anagliptin |
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
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