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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07282054 | Efficacy and Safety of THDB0206 Compared to Insulin Lispro Injection in Participants With Type 1 Diabetes | PHASE3 | COMPLETED | 550 | — | — | Apr 13, 2022 | Jan 24, 2025 | Dec 15, 2025 | 1 | China |
| Arm | Type | Description |
|---|---|---|
| THDB0206 Injection | EXPERIMENTAL | - |
| Insulin Lispro Injection | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| THDB0206 | DRUG | Subcutaneous THDB0206 three times daily, with individualized dose adjustment. |
| Insulin Lispro | DRUG | Subcutaneous insulin lispro three times daily, with individualized dose adjustment. |
| Insulin Glargine | DRUG | Subcutaneous insulin glargine once daily, with individualized dose adjustment. |
Inclusion Criteria: 1. Male or female participants, 18 to 75 years of age at informed consent (inclusive). 2. BMI between 18.0 and 30.0 kg/m² (inclusive). 3. T1DM diagnosed ≥6 months per WHO diabetes classification (2019). 4. On insulin therapy ≥6 months prior to screening. 5. Stable insulin regime...