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This study evaluates the efficacy and safety of adding the SGLT-2 inhibitor DA5221-T to the combination therapy of DA5221-B1 and the DPP-4 inhibitor DA5221-B2 in patients with type 2 diabetes who have inadequate blood glucose control. The study focuses on assessing the effectiveness and safety of the triple combination therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DA5221-T1 + DA5221-R2 + DA5221-B1 + DA5221-B2 | Experimental |
| |
| DA5221-R1 + DA5221-T2 + DA5221-B1 + DA5221-B2 | Experimental |
| |
| DA5221-R1 + DA5221-R2 + DA5221-B1 + DA5221-B2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA5221-T1 | Drug | DA5221-T1 + DA5221-R2, orally, once daily, up to 24 weeks |
|
| 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 |
|---|---|---|---|---|---|---|
| Severance Hospital, Yonsei University college of Medicine | Seoul | South Korea |
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| DA5221-T2 | Drug | DA5221-R1 + DA5221-T2, orally, once daily, up to 24 weeks |
|
| Placebo | Drug | DA5221-R1 + DA5221-R2, orally, once daily, up to 24 weeks |
|
| DA5221-B1 | Drug | DA5221-B1, orally, daily for background therapy |
|
| DA5221-B2 | Drug | DA5221-B2, 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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