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A multicenter, randomized, placebo-controlled clinical trial, double-blind, parallel-group
Phase 3 study in patients with T2DM, who have inadequate glycemic control on Drug A alone or Drug A in combination with antihyperglycemic drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DWP16001 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP16001 0.3mg | Drug | 1 tablet, Orally, Once daily single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from Baseline HbA1c | at Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
Patients with type 1 diabetes mellitus (T1DM), congenital diabetes mellitus (DM), or secondary diabetes as follows:
Patients receiving SGLT2 inhibitors, GLP-analogues, thiazolidinediones, or sulfonylureas (at Screening and Run in).
At Visit 1 (Screening), patients with a history of the following:
Patients who are on or likely to require treatment for ≥14 consecutive days or repeated courses of pharmacologic doses of corticosteroids.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Younghee Kim | Contact | 82-10-5768-9733 | 2210285@daewoong.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | 135-710 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41397686 | Derived | Hong JH, Min KW, Lee CB, Chamnan P, Sirirak T, Sony K, Sattanon S, Kim HJ, Kim SY, Kim Y, Heo JA, Cho JM, Nah JJ, Park MH, Kim JH. Efficacy and Safety of Enavogliflozin as Add-on in Adults with Type 2 Diabetes Mellitus Inadequately Controlled with Insulin or Insulin with Other Antidiabetic Drugs. Diabetes Metab J. 2025 Dec 15. doi: 10.4093/dmj.2025.0477. Online ahead of print. |
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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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| DWP16001 Placebo |
| Drug |
1 tablet, Orally, Once daily single dose |
|
| D004700 | Endocrine System Diseases |