NCT07224321RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 31 Oct 2025
- Start date
- 4 Feb 2026
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Mannkind Corporation
- Diseases
- Type 1 diabetes
- NCT number
- NCT07224321
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 4 Feb 2026 to the primary completion date, 31 Mar 2027
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior insulin treatment for stage 2 T1D
- Smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) within 3 months prior to screening and/or positive cotinine test for smoking
Other illness
- 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
Other
- Positive urine pregnancy test for female subjects of childbearing potential
Who the study is looking for
- Age 6 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
Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Barbara Davis Center for Diabetes Young Adult Clinic Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Joslin Diabetes Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
| University of Florida Coordinator of this site? Confirm its status | Gainsville | United States | Recruiting |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| Children's Hospital Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.