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The purpose of this study is evaluate the long term safety and efficacy of DWP16001 compared to placebo in the treatment of type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DWP16001 | Experimental | DWP16001 Tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP16001 Amg | Drug | DWP16001 Amg, Tablets, Orally, Once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in Adverse events (AEs) and adverse events of special interest (AESIs)* at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP | *Hypoglycemia, urinary tract infection, genital infection, pollakiuria, or polyuria | at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline* in HbA1c at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP | * Visit 2 (randomization) of the prior phase 3 study (Protocol No: DW_DWP16001301) | at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP |
| Changes from baseline* in FPG at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP |
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Inclusion Criteria:
Exclusion Criteria:
Those who dropped out of the previously conducted phase 3 clinical trial (Protocol No: DW_DWP16001301)
Pregnant or lactating women or those who do not consent to the use of appropriate contraceptive methods during clinical trials Appropriate method of birth control for you or your partner: You must agree to one of the following
In case the investigator judges that participation in this extended clinical trial is inappropriate in consideration of the 24-week observation progress in the previously conducted phase 3 clinical trial (Protocol No: DW_DWP16001301)
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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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* Visit 2 (randomization) of the prior phase 3 study (Protocol No: DW_DWP16001301) |
| at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP |
| Proportion of subjects achieving HbA1c target of < 7% at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP | * Visit 2 (randomization) of the prior phase 3 study (Protocol No: DW_DWP16001301) | at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP |
| D004700 | Endocrine System Diseases |