NCT07224321

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

INHALE-1st: Technosphere Insulin (Afrezza®) In Combination With Basal Insulin For Youth With Newly-Diagnosed Type 1 Diabetes

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Mannkind Corporation · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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 10 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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Technosphere Insulin	2 unit
DRUG	Technosphere Insulin	4, 8, 12 units
DRUG	Basal insulin	subcutaneously-injected basal insulin

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-11-01
• Completion: 2027-07-01
• First posted: 2025-11-04
• Last updated: 2026-03-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study