Afrezza® INHALE-1 Study in Pediatrics

About the trial

Sponsor

Mannkind Corporation (with Jaeb Center for Health Research)

Tested

Afrezza (biological), Rapid-acting Insulin Analog (biological), Basal Insulin (biological)

Dates

Started 2021-09-29; completion 2025-04-29

Results posted

Not yet

INHALE-1 is a Phase 3, open-label, randomized clinical study evaluating the efficacy and safety of Afrezza in combination with a basal insulin (i.e., the Afrezza group) versus insulin aspart, insulin lispro or insulin glulisine in combination with a basal insulin (i.e., the Rapid-acting Insulin Analog \[RAA\] injection group) in pediatric subjects with type 1 or type 2 diabetes mellitus. Following 26 weeks of randomized treatment (i.e., Afrezza or RAA injection combined with a basal insulin), all subjects will enter a treatment extension where subjects will receive Afrezza until Week 52. The purpose of the treatment extension is to assess safety and efficacy with continued use of Afrezza.…

From ClinicalTrials.gov, last updated 2025-05-06. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Mannkind Corporation reported $80,574 in research payments for this study in 2025 (249 payments).

Products named: Afrezza

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.