Afrezza plus basal insulin for newly diagnosed Type 1 diabetes in youth
INHALE-1st: Technosphere Insulin (Afrezza®) In Combination With Basal Insulin For Youth With Newly-Diagnosed Type 1 Diabetes
This trial tests whether adding inhaled Afrezza to daily basal insulin helps 10 to 17-year-olds newly diagnosed with type 1 diabetes control their blood sugar and feel better about treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 10 Years to 17 Years |
| Sex | All |
| Sponsor | Mannkind Corporation Industry-sponsored |
| Locations | 10 sites (Los Angeles, California and 9 other locations) |
| Trial ID | NCT07224321 on ClinicalTrials.gov |
What this trial studies
In this Phase 2, single-arm, multicenter study, participants aged 10 to <18 with newly diagnosed stage 3 type 1 diabetes will start inhaled rapid-acting technosphere insulin (Afrezza) together with injected basal insulin within 21 days of diagnosis. Participants will be followed for a 13-week main phase, with an optional extension for up to 26 weeks for those who continue Afrezza plus basal insulin. The trial will collect safety data (including regular FEV1 lung function checks), measures of glycemic control, and questionnaires on participant and parent/guardian satisfaction. Enrollment excludes children with chronic pulmonary disease, prior insulin treatment for stage 2 disease, or reduced lung function (FEV1 ≤80% predicted).
Who should consider this trial
Good fit: Ideal candidates are 10 to <18 years old with a clinical diagnosis of stage 3 type 1 diabetes who can begin the Afrezza plus basal insulin regimen within 21 days of diagnosis and have normal lung function (FEV1 >80% predicted).
Not a fit: Children with chronic lung disease, low lung function, prior insulin treatment for stage 2 diabetes, or those unable to attend study visits are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could offer newly diagnosed teens a rapid, inhaled mealtime insulin option that may improve glucose control and convenience compared with injected mealtime insulin.
How similar studies have performed: Afrezza (technosphere insulin) is approved for adults and has shown effectiveness and acceptable safety in adult trials, but randomized data and experience in newly diagnosed children remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 this trial is running
Los Angeles, California and 9 other locations
- Children's Hospital Los Angeles — Los Angeles, California, United States (Not_yet_recruiting)
- University of California San Francisco — San Francisco, California, United States (Not_yet_recruiting)
- Barbara Davis Center for Diabetes Young Adult Clinic — Aurora, Colorado, United States (Recruiting)
- Yale University — New Haven, Connecticut, United States (Not_yet_recruiting)
- University of Florida — Gainesville, Florida, United States (Not_yet_recruiting)
- Indiana University — Indianapolis, Indiana, United States (Not_yet_recruiting)
- Joslin Diabetes Center — Boston, Massachusetts, United States (Recruiting)
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (Not_yet_recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Not_yet_recruiting)
- University of Virginia — Charlottesville, Virginia, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Jennifer Pleitez
- Email: jpleitez@mannkindcorp.com
- Phone: 818-661-5032
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.