INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes

INHALE-1st is a Phase 2, single-arm, multi-center, clinical study evaluating the safety and efficacy of Afrezza in combination with subcutaneously-injected basal insulin (BI) for youth 6 to \<18 years old with newly diagnosed stage 3 type 1 diabetes (T1D). The study will also evaluate the effect of an Afrezza plus BI reigmen on participant and parent/legally authorized representative satisfaction. Participants will be followed for 13 weeks during the main phase followed by an optional Extension Phase for participants continuing to use Afrezza in combination with BI for up to 26 weeks.

NCT Number	NCT07224321
Lead Sponsor	Mannkind Corporation Collaborators: Jaeb Center for Health Research
Conditions	Type 1 Diabetes Mellitus
Enrollment	100 participants
Start Date	2026-02-04
Primary Completion	2027-03 (estimated)
Study Completion	2027-09 (estimated)
Updated on ClinicalTrials.gov	2026-08-13