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

Recruiting now · Phase 2

Conditions studied: Type 1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT07224321

Run by

Mannkind Corporation

People needed

100

Starts

2026-02-04

Expected to finish

2027-09-01

Last updated by the study team

2026-07-07

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 10 to <18 years of age
• Clinical diagnosis of stage 3 T1D, per the investigator. Stage 3 is defined as hyperglycemia, meeting ADA glycemic and clinical diagnostic criteria
• Able to start the Afrezza-BI regimen within 21 days following T1D diagnosis (day 1 is based on the first insulin dose)
• Forced Expiratory Volume in One Second (FEV1) >80.0% of predicted Global Lung Function Initiative (GLI) value
• Investigator believes that participant can be expected to follow the study protocol
• No medical, psychiatric, psychosocial conditions, or medications being taken that in the investigator's judgment would be a safety concern for participation in the study

You may not qualify if…

• Prior insulin treatment for stage 2 T1D
• In the judgment of the investigator, history of chronic lung disease, such as asthma, or chronic obstructive pulmonary disease, lung cancer, or any other clinically important pulmonary disease (e.g., cystic fibrosis, bronchopulmonary dysplasia)
• Allergy or known hypersensitivity to human regular insulin
• Smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) within 3 months prior to screening and/or positive cotinine test for smoking
• Positive urine pregnancy test for female subjects of childbearing potential

Where it is running

• University of Virginia — Charlottesville, Virginia, United States (enrolling)
• University of California San Francisco — San Francisco, California, United States (enrolling)
• Barbara Davis Center for Diabetes Young Adult Clinic — Aurora, Colorado, United States (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• University of Florida — Gainesville, Florida, United States (enrolling)
• Indiana University — Indianapolis, Indiana, United States (enrolling)
• Joslin Diabetes Center — Boston, Massachusetts, United States (enrolling)
• Children's Hospital Los Angeles — Los Angeles, California, United States (enrolling)
• Baylor College of Medicine — Houston, Texas, United States (enrolling)
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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