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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04974528 | Afrezza® INHALE-1 Study in Pediatrics | PHASE3 | COMPLETED | 319 | — | — | Sep 29, 2021 | Apr 29, 2025 | May 6, 2025 | 39 | United States |
Change in HbA1c from baseline to Week 26, for noninferiority assessment
| Arm | Type | Description |
|---|---|---|
| Afrezza (Technosphere Insulin) + Basal Insulin | EXPERIMENTAL | Individualized dose of Afrezza (Technosphere Insulin) for each patient before each meal (breakfast, lunch, and dinner) for 26 weeks. Individualized basal insulin (insulin degludec, insulin glargine or insulin detemir) for each patient. |
| RAA Injection + Basal Insulin | ACTIVE_COMPARATOR | Individualized dose of RAA injection (insulin aspart, insulin lispro or insulin glulisine) for each patient for 26 weeks. Individualized basal insulin (insulin degludec, insulin glargine or insulin detemir) for each patient. |
| Name | Type | Description |
|---|---|---|
| Afrezza | BIOLOGICAL | Pharmaceutical form: powder Route of administration: inhalation |
| Rapid-acting Insulin Analog | BIOLOGICAL | Pharmaceutical form: clear and colorless solution for injection Route of administration: subcutaneous |
| Basal Insulin | BIOLOGICAL | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
Inclusion Criteria: * Assent from the pediatric subject, as appropriate, and fully informed consent from the parent(s) or legal guardian, as required by both state and federal laws and the local Institutional Review Board (IRB) * Subjects ≥4 and \<18 years of age * Clinical diagnosis of type 1 diab...