Inhaled Afrezza with basal insulin for youth with new type 1 diabetes
Tests inhaled Afrezza with basal insulin in youth with new type 1 diabetes.
Plain-language title generated from the registry record
Registry title: INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes
Key facts
- Where
- Aurora, Boston, Charlottesville, Gainsville, Houston, Indianapolis, Los Angeles, New Haven, Oklahoma City, and San Francisco, United StatesSee the 10 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 17 years old?
Source: NCT07224321, who can take part
Where in United States
- Barbara Davis Center for Diabetes Young Adult ClinicAurora, United StatesTaking people
- Joslin Diabetes CenterBoston, United StatesTaking people
- University of VirginiaCharlottesville, United StatesTaking people
- University of FloridaGainsville, United StatesTaking people
- Baylor College of MedicineHouston, United StatesTaking people
- Indiana UniversityIndianapolis, United StatesTaking people
- Children's Hospital Los AngelesLos Angeles, United StatesTaking people
- Yale UniversityNew Haven, United StatesTaking people
- University of Oklahoma Health Sciences CenterOklahoma City, United StatesTaking people
- University of California San FranciscoSan Francisco, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mannkind Corporation
- Trial code
- NCT07224321
- Record updated
- 13 August 2026
- Original description
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.Read full original descriptionShow less
INHALE-1st: Technosphere Insulin (Afrezza®) In Combination With Basal Insulin For Youth With Newly-Diagnosed Type 1 Diabetes
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.
Inclusion: 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.
Exclusion: 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; 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; Positive urine pregnancy test for female subjects of childbearing potential.