clinical trial · NCT07224321
INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes
Type 1 Diabetes MellitusTechnosphere InsulinTechnosphere InsulinBasal insulin
brief 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.
started
Feb 4, 2026
primary completion
Mar 1, 2027
completion
Sep 1, 2027
last updated
May 18, 2026
official title
INHALE-1st: Technosphere Insulin (Afrezza®) In Combination With Basal Insulin For Youth With Newly-Diagnosed Type 1 Diabetes
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol