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A multicenter, randomized, double-blind, parallel group, placebo-controlled, phase 3 study to evaluate the efficacy and safety of the combination of A51R3 and AJU-A51 compared with the combination of A51R3 and A51R2 in patients with Type 2 diabetes mellitus who have inadequate glycemic control with the combination of A51R3 and A51R2
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AJU-A51+A51R2 placebo+A51R3 | Experimental |
| |
| AJU-A51 placebo+A51R2+A51R3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AJU-A51 | Drug | Subjects take the investigational products once a day for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in HbA1c | Changes in HbA1c at the 24th week after the administration of investigational products from the baseline | 24th week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39375869 | Derived | Hong JH, Kim MJ, Min KW, Won JC, Kim TN, Lee BW, Kang JG, Kim JH, Park JH, Ku BJ, Lee CB, Kim SY, Shon HS, Lee WJ, Park JY. Efficacy and safety of a fixed-dose combination of dapagliflozin and linagliptin (AJU-A51) in patients with type 2 diabetes mellitus: A multicentre, randomized, double-blind, parallel-group, placebo-controlled phase III study. Diabetes Obes Metab. 2025 Jan;27(1):81-91. doi: 10.1111/dom.15985. Epub 2024 Oct 7. |
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| A51R2 | Drug | Subjects take the investigational products once a day for 24 weeks. |
|
| A51R3 | Drug | Subjects take the investigational products once a day for 24 weeks. |
|
| AJU-A51 Placebo | Drug | Subjects take the investigational products once a day for 24 weeks. |
|
| A51R2 Placebo | Drug | Subjects take the investigational products once a day for 24 weeks. |
|