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RecruitingPhase 2

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

Mannkind Corporation · with Jaeb Center for Health Research · NCT07224321

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 6–17 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
100
US sites recruiting
10
Study start
February 4, 2026
Record last updated
August 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Technosphere Insulin; Technosphere Insulin; Basal insulin

Conditions: Type 1 Diabetes Mellitus

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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 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

Recruiting US locations

  • Children's Hospital Los Angeles

    Los Angeles, CA 90027

    Site contact: Pamela Parcon · 323-203-8744 · pparcon@chla.usc.edu

  • University of California San Francisco

    San Francisco, CA 94158

    Site contact: Avani Narayan · 415-530-8047 · Avani.Narayan@ucsf.edu

  • Barbara Davis Center for Diabetes Young Adult Clinic

    Aurora, CO 80045

    Site contact: Cari Berget · 303-724-8977 · cari.berget@cuanschutz.edu

  • Yale University

    New Haven, CT 06511

    Site contact: Amy Steffen, BSN · 203-737-8852 · Amy.steffen@yale.edu

  • University of Florida

    Gainsville, FL 32610

    Site contact: Sarah Peeling · 352-273-5275 · smpeeling@peds.ufl.edu

  • Indiana University

    Indianapolis, IN 46202

    Site contact: Sana Kalaji · 317-274-0306 · skalaji@iu.edu

  • Joslin Diabetes Center

    Boston, MA 02215

    Site contact: Kerry Milaszewski · 617-975-8209 · Kerry.Milaszewski@joslin.harvard.edu

  • University of Oklahoma Health Sciences Center

    Oklahoma City, OK 73104

    Site contact: Deidre Graham, RN · 405-271-8001 · deidre-graham@ou.edu

  • Baylor College of Medicine

    Houston, TX 77030

    Site contact: Anh Nguyen · 832-822-3870 · anh.nguyen2@bcm.edu

  • University of Virginia

    Charlottesville, VA 22903

    Site contact: Sara Prince · 434-320-5599 · SP4SA@uvahealth.org

Study contacts (from the official record)

  • Jennifer Pleitez · 818-661-5032 · jpleitez@mannkindcorp.com
All diabetes studies in California →
INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes (NCT07224321) | Bored Studies