Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06329674 | Efficacy and Safety of AJU-A51 in Type 2 Diabetes Mellitus Patients | PHASE3 | COMPLETED | 235 | — | — | Apr 27, 2021 | Jun 13, 2023 | Mar 26, 2024 | 1 | South Korea |
Changes in HbA1c at the 24th week after the administration of investigational products from the baseline
| Arm | Type | Description |
|---|---|---|
| AJU-A51+A51R2 placebo+A51R3 | EXPERIMENTAL | - |
| AJU-A51 placebo+A51R2+A51R3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AJU-A51 | DRUG | Subjects take the investigational products once a day for 24 weeks. |
| 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. |
Inclusion Criteria: * Those who voluntarily signed the informed consent to participate in this study. * Adults aged 19-75 years. * Those diagnosed with type 2 diabetes mellitus. * 7% ≤ HbA1c ≤ 10.5% * FPG ≤ 270 mg/dL * BMI ≤ 40 kg/㎡ * Subjects able to understand the study, comply with study procedu...