RecruitingPhase 2NCT07224321

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


Sponsor

Mannkind Corporation

Enrollment

100 participants

Start Date

Feb 4, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 10 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using inhaled insulin (Afrezza) as part of a treatment regimen in the first days after a Type 1 diabetes diagnosis can help preserve the body's remaining insulin-producing cells and improve blood sugar control. It is specifically for children and teenagers who have just been diagnosed with Type 1 diabetes. **You may be eligible if...** - You are between 10 and 17 years old - You have been newly diagnosed with Type 1 diabetes (stage 3, meaning you have symptoms and elevated blood sugar) - Treatment can begin within 10 days of your first insulin injection (or within 10 days of being discharged if you were hospitalized) - Your lung function is normal or near normal (FEV1 above 80% of expected) **You may NOT be eligible if...** - You previously received insulin treatment for stage 2 (pre-symptomatic) Type 1 diabetes - You have a chronic lung condition such as asthma, COPD, cystic fibrosis, or any other serious lung disease - You are allergic to human regular insulin - You are currently smoking Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTechnosphere Insulin

2 unit

DRUGTechnosphere Insulin

4, 8, 12 units

DRUGBasal insulin

subcutaneously-injected basal insulin


Locations(10)

Children's Hospital Los Angeles

Los Angeles, California, United States

University of California San Francisco

San Francisco, California, United States

Barbara Davis Center for Diabetes Young Adult Clinic

Aurora, Colorado, United States

Yale University

New Haven, Connecticut, United States

University of Florida

Gainsville, Florida, United States

Indiana University

Indianapolis, Indiana, United States

Joslin Diabetes Center

Boston, Massachusetts, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Baylor College of Medicine

Houston, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07224321


Related Trials