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Phase 3 study to assess the Efficacy and Safety of YYC405 in Type 2 Diabetes Patients
Phase 3 study to assess the Efficacy and Safety of YYC405-T when added to Metformin and Dapagliflozin combination therapy in patients with type 2 diabetes mellitus who have inadequate glycemic control
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Take YYC405-T and Metforminâ„1000mg, Dapagliflozin 10mg |
|
| Placebo control | Placebo Comparator | Take YYC405-T Placebo and Metforminâ„1000mg, Dapagliflozin 10mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YYC405-T | Drug | Subjects take the investigational products once a day for 24 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Change from baseline in Glycosylated Hemoglobin (HbA1c) | Baseline, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Change from baseline in Glycosylated Hemoglobin (HbA1c) | Baseline, 12weeks |
| FPG, Fasting insulin | Change from baseline in Fasing plasma glucose and Fasting insulin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sungrae Kim, MD, Ph.D | Bucheon St Mary Hospital | Study Chair |
| 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 |
|---|---|---|---|
| 38425186 | Derived | Lim S, Lee SH, Min KW, Lee CB, Kim SY, Yoo HJ, Kim NH, Kim JH, Oh S, Won JC, Kwon HS, Kim MK, Park JH, Jeong IK, Kim S. A multicentre, double-blind, placebo-controlled, randomized, parallel comparison, phase 3 trial to evaluate the efficacy and safety of pioglitazone add-on therapy in type 2 diabetic patients treated with metformin and dapagliflozin. Diabetes Obes Metab. 2024 Jun;26(6):2188-2198. doi: 10.1111/dom.15526. Epub 2024 Feb 29. |
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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 |
|---|---|
| C529054 | dapagliflozin |
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a Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel group
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Double-blind
| Metforminâ„1000mg |
| Drug |
Subjects take the investigational products once a day for 24 weeks. |
|
| Dapagliflozin 10mg | Drug | Subjects take the investigational products once a day for 24 weeks. |
|
| YYC405-T placebo | Drug | Microcrystalline cellulose, Subjects take the investigational products once a day for 24 weeks. |
|
| Baseline, 12weeks, 24weeks |
| C-peptide | Change from baseline in C-peptide | Baseline, 12weeks, 24weeks |
| D004700 | Endocrine System Diseases |