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This study evaluates the addition of dapagliflozin in the treatment of type 2 diabetes with metformin and evogliptin combination therapy. Half of subjects will receive dapagliflozin, metformin and evogliptin, while the other half will receive placebo, metformin and evogliptin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin 10mg + Evogliptin 5mg + Metformin | Experimental |
| |
| Dapagliflozin Placebo + Evogliptin 5mg + Metformin | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin 10mg | Drug | Dapagliflozin 10mg, orally, once daily, up to 24weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from the baseline in HbA1c (%) after 24 weeks | Baseline, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from the baseline in fasting plasma glucose(mg/dL) after 24 weeks | Baseline, 24 weeks | |
| Change from the baseline in HbA1c response rate(<7.0%, <6.5%) after 24 weeks | Baseline, 24 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea Bucheon St. Mary's Hospital | Bucheon-si | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39223856 | Derived | Jeong IK, Choi KM, Han KA, Kim KA, Kim IJ, Han SJ, Lee WY, Yoo SJ. Efficacy and safety of dapagliflozin add-on to evogliptin plus metformin therapy in patients with type 2 diabetes: A randomized, double-blind, placebo-controlled study. Diabetes Obes Metab. 2024 Nov;26(11):5065-5077. doi: 10.1111/dom.15838. Epub 2024 Sep 2. |
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| Placebo | Drug | Dapagliflozin Placebo, orally, once daily, up to 24weeks |
|
| Evogliptin 5mg | Drug | Evogliptin 5mg, orally, once daily for background therapy |
|
|
| Metforminâ„1000mg | Drug | Metforminâ„1000mg, orally, daily for background therapy |
|
| Change from the baseline in weight after 24 weeks |
| Baseline, 24 weeks |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| C557982 | 4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one |
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