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The purpose of this study is to determine the efficacy and safety of DWP16001 compared to placebo in the treatment of type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DWP16001 Amg | Experimental | DWP16001 Amg, Tablets, Orally, Once daily |
|
| DWP16001 Bmg | Experimental | DWP16001 Bmg, Tablets, Orally, Once daily |
|
| DWP16001 Cmg | Experimental | DWP16001 Cmg, Tablets, Orally, Once daily |
|
| Placebo | Placebo Comparator | Placebo, Tablets, Orally, Once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP16001 | Drug | DWP16001 tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbA1c | at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in FPG | at week 4, 8, 12 | |
| The proportion of patients who achieve HbA1c < 7.0%, HbA1c < 6.5% and HbA1c reduction >0.5% from baseline | at week 4, 8, 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Choi | Contact | jhchoi413@daewoong.co.kr | ||
| Hyun | Contact | wrhyun075@daewoong.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daewoong pharmatceutical | Recruiting | 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 |
|---|---|
| C000729921 | Enavogliflozin |
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| Placebo |
| Drug |
DWP16001 placebo-matching tablets |
|
| D004700 | Endocrine System Diseases |