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This trial is to evaluate the efficacy and safety of CWP-0403 at 100 mg or 200 mg twice daily compared with placebo in type 2 diabetic patients with inadequate glycemic control by diet therapy or combination of diet and exercise therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo of CWP-0403 100mg | Placebo Comparator | Placebo of CWP-0403 100mg |
|
| CWP-0403 200mg | Experimental | CWP-0403 200mg |
|
| CWP-0403 100mg | Experimental | CWP-0403 100mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anagliptin | Drug | Anagliptin 100mg, tablet, BID |
| |
| Anagliptin |
| 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<6.5% at week24 | 0wk, 8wk, 16wk, 24wk | |
| The proportion of subjects achieving HbA1c<7% at week24 | 0wk, 8wk, 16wk, 24wk | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sung Woo Park, M.D., PhD | Kangbuk Samsung Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kangbuk Samsung Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C583175 | anagliptin |
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| Drug |
Anagliptin 100mg, tablet, BID |
|
| Placebo of Anagliptin | Drug | Placebo of Anagliptin 100mg, tablet, BID |
|
| The change from baseline to week 24: Fasting plasma glucose |
| 0wk, 24wk |
| change from baseline to week 24 in Fasting serum insulin | 0 wk, 24 wk |
| change from baseline to week 24 in Fasting serum pro-insulin | 0 wk, 24wk |
| change in from baseline to week 24 fasting serum c-peptide | 0wk, 24wk |
| change from baseline to week 24 in HOMA-β | owjm 24wk |
| change from baseline to week 24 in HOMA-IR | 0wk, 24 wk |
| D004700 | Endocrine System Diseases |