Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Afrezza · 2 trials · 3 indications
Change in HbA1c from baseline to Week 26, for noninferiority assessment
Insulin Cmax after a dose of Afrezza
| 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. |
| Afrezza (Technosphere Insulin) | EXPERIMENTAL | Individualized dose of Afrezza (Technosphere Insulin) for each patient at each meal (breakfast, lunch, and dinner) for 30 days. During the trial, all patients will receive multiple injections of basal long acting insulin, in general at bedtime every day. |
| 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...
Afrezza is an investigational drug being studied for the treatment of Type 1 Diabetes Mellitus. It is a monoclonal antibody developed by MannKind Corporation. Afrezza is currently in Phase 3 clinical development and has not been approved by the FDA.
Afrezza is a monoclonal antibody, but its specific molecular target has not been disclosed. It is being studied for its effects on Type 1 Diabetes Mellitus, a metabolic condition. The mechanism of action is not fully understood at this time.
Afrezza is developed by MannKind Corporation, a biopharmaceutical company. The company is conducting clinical trials to evaluate the safety and efficacy of Afrezza in patients with Type 1 Diabetes Mellitus.
Afrezza is currently in Phase 3 clinical development. It has completed a Phase 3 trial and a Phase 2 trial. Afrezza is investigational and has not been approved by the FDA for any indication.
Afrezza has been studied in two clinical trials. The Phase 3 trial NCT04974528, known as the INHALE-1 study, enrolled 319 patients with Type 1 or Type 2 Diabetes Mellitus. The Phase 2 trial NCT02527265 enrolled 30 patients with Type 1 Diabetes Mellitus. Both trials are completed.
Afrezza is not the same as insulin. It is a monoclonal antibody being studied for Type 1 Diabetes Mellitus, whereas insulin is a hormone used to regulate blood sugar. Afrezza's mechanism of action is distinct from insulin replacement therapy.