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A Randomized, Double-blind, Multi-center, Placebo-controlled, Phase III Trial to Evaluate the Efficacy and Safety of DW1026C1 or DW1026C2 Add-on to Metformin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin and Sitagliptin Combination Therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DW1026C1 & DW1026C2 placebo & DW1026S placebo | Experimental |
| |
| DW1026C1 placebo & DW1026C2 & DW1026S placebo | Experimental |
| |
| DW1026C1 placebo & DW1026C2 placebo & DW1026S | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DW1026C1 | Drug | Sitagliptin 100mg+Empagliflozin 10mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| % change of HbA1c | % change of HbA1c in week 24 from baseline | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yeouido St. Mary's Hospital The Catholic University | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41883295 | Derived | Lim S, Kim TN, Mok JO, Chung CH, Hwang YC, Cho HC, Won JC, Jeon E, Kang ES, Lee KY, Kim CH, Kwak SH, Park CY, Park KS, Kim SY, Lee JH, Lee SH, Cho DH, Kwon HS, Han KA. Efficacy and Safety of Fixed-Dose Combinations of Sitagliptin and Empagliflozin as Add-On to Metformin in Korean Patients With Type 2 Diabetes: A Randomised, Double-Blind, Multi-Centre, Placebo-Controlled, Phase III Trial. Diabetes Obes Metab. 2026 Jun;28(6):4847-4859. doi: 10.1111/dom.70669. Epub 2026 Mar 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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| DW1026C2 |
| Drug |
Sitagliptin 100mg+Empagliflozin 25mg |
|
| DW1026S | Drug | Sitagliptin 100mg |
|
| D004700 | Endocrine System Diseases |