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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 Amg Placebo | Placebo Comparator | DWP16001 Amg Placebo, Tablets, Orally, Once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP16001 | Drug | DWP16001 A mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c level at Week 24 after administration of the IP | 1.Change from Visit 2 (randomization) in HbA1c level at Week 24 after administration of the IP | at Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c level at Weeks 6, 12, and 18 after administration of the IP | 1.Changes from Visit 2 (randomization) in HbA1c level at Weeks 6, 12, and 18 after administration of the IP | at weeks 6, 12, and 18 |
| FPG level at Weeks 6, 12, 18, and 24 after administration of the IP |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daewoong pharmatceutical | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39054871 | Derived | Kwak SH, Han KA, Kim ES, Choi SH, Won JC, Yu JM, Oh S, Yoo HJ, Kim CH, Kim KS, Chun S, Kim YH, Cho SA, Kim DH, Park KS. Long-term efficacy and safety of enavogliflozin in Korean people with type 2 diabetes: A 52-week extension of a Phase 3 randomized controlled trial. Diabetes Obes Metab. 2024 Oct;26(10):4203-4212. doi: 10.1111/dom.15738. Epub 2024 Jul 26. |
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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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2.Changes from Visit 2 (randomization) in FPG level at Weeks 6, 12, 18, and 24 after administration of the IP |
| at weeks 6, 12, 18, and 24 |
| HbA1c level < 7% at Weeks 6, 12, 18, and 24 after administration of the IP | 3.Proportions of subjects who achieved HbA1c level < 7% at Weeks 6, 12, 18, and 24 after administration of the IP | at weeks 6, 12, 18, and 24 |
| D004700 | Endocrine System Diseases |