INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes
Public ClinicalTrials.gov record NCT07224321. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
INHALE-1st: Technosphere Insulin (Afrezza®) In Combination With Basal Insulin For Youth With Newly-Diagnosed Type 1 Diabetes
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07224321
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 100 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 4, 2026 (Actual)
- Primary completion
- Mar 2027 (Estimated)
- Completion
- Sep 2027 (Estimated)
- Last update posted
- Aug 13, 2026
2026 – 2027
United States locations
- U.S. sites
- 10
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | Recruiting |
| University of California San Francisco | San Francisco | California | 94158 | Recruiting |
| Barbara Davis Center for Diabetes Young Adult Clinic | Aurora | Colorado | 80045 | Recruiting |
| Yale University | New Haven | Connecticut | 06511 | Recruiting |
| University of Florida | Gainsville | Florida | 32610 | Recruiting |
| Indiana University | Indianapolis | Indiana | 46202 | Recruiting |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | Recruiting |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | Recruiting |
| Baylor College of Medicine | Houston | Texas | 77030 | Recruiting |
| University of Virginia | Charlottesville | Virginia | 22903 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07224321, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 13, 2026 · Synced Oct 26, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07224321 live on ClinicalTrials.gov.