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This is a randomized, open-label, active-controlled, parallel, multicenter, phase IV clinical study evaluating the efficacy and safety of switching Metformin+SGLT2-i+DPP4-i to Metformin+SGLT2-i+TZD in patients with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin + Dapagliflozin 10mg/Pioglitazone 30mg | Experimental | One tablet of Metformin and one tablet of Dapagliflozin 10mg/Pioglitazone 30mg administered orally once daily for 24 weeks. |
|
| Metformin + Dapagliflozin 10mg/Sitagliptin 100mg | Active Comparator | One tablet of Metformin and one tablet of Dapagliflozin 10mg/Sitagliptin 100mg administered orally once daily for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | The dosage and dose frequency are maintained as they were before the screening. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c (%) change at 24 weeks compared to the baseline (Visit 2) | The mean change of HbA1c at 24 weeks compared to the baseline (Visit 2) is evaluated. | From baseline to end of treatment at 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oh | Contact | +82 2-708-8000 | syoh@boryung.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea, Seoul St. Mary's Hospital | Recruiting | Seoul | Seocho District | 06591 | South Korea |
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| Dapagliflozin/Pioglitazone | Drug | Dapagliflozin 10mg/Pioglitazone 30mg QD |
|
| Dapagliflozin/Sitagliptin | Drug | Dapagliflozin 10mg/Sitagliptin 100mg QD |
|
| 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 |
|---|---|
| D008687 | Metformin |
| C529054 | dapagliflozin |
| D000077205 | Pioglitazone |
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014230 | Triazoles |
| D011719 | Pyrazines |
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