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Label indication AFREZZA ® is indicated to improve glycemic control in adult and pediatric patients 6 years of age and older with diabetes mellitus. AFREZZA ® is a rapid acting inhaled human insulin indicated to improve glycemic control in adult and pediatric patients 6 years of age and older with diabetes mellitus. FDA label
Also known as Technosphere Insulin
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 inhaled insulin product developed by MannKind Corporation for the treatment of Type 1 Diabetes Mellitus. It is being studied in pediatric patients with Type 1 and Type 2 diabetes, including a Phase 3 trial in children as young as 4 years old.
Afrezza is made by MannKind Corporation, which trades on the Nasdaq under the ticker MNKD. MannKind is the developer responsible for the Afrezza program, including the pediatric clinical studies conducted in the United States.
Afrezza has been evaluated in a Phase 3 pediatric study, the INHALE-1 trial, and an earlier Phase 2 safety and pharmacokinetics study in pediatric patients. Both trials are listed as completed, and no Afrezza trials are currently active.
Afrezza has been studied in two completed trials. NCT04974528, the Phase 3 INHALE-1 pediatric study, enrolled 319 participants with Type 1 or Type 2 diabetes. NCT02527265, a Phase 2 safety and pharmacokinetics study, enrolled 30 pediatric patients with Type 1 Diabetes Mellitus.
The two completed Afrezza trials together enrolled 349 participants. The Phase 3 INHALE-1 study contributed 319 of those participants, and the Phase 2 pediatric safety and pharmacokinetics study contributed 30. Both studies enrolled patients aged 4 years and older in the United States.
Yes. The Afrezza trials were randomized and used an active-controlled design, meaning participants received a comparator treatment rather than a placebo. The studies were not double-blind, and enrollment was not restricted to patients selected by a biomarker.