Recruiting
Phase 2

Afrezza & Basal Insulin

Sponsor:

Mannkind Corporation

Code:

NCT07224321

Conditions

Type 1 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Technosphere Insulin

Technosphere Insulin

Basal insulin

Study Details

Brief summary:

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.

Conditions

Type 1 Diabetes Mellitus

Study ID

NCT07224321

Start date

Feb 4, 2026

Status verified date

Aug, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Afrezza (Technosphere Insulin) + Basal Insulin

Individualized dose of Afrezza (Technosphere Insulin) and basal insulin for each patient before each meal (breakfast, lunch, and dinner) for 13 weeks.

Interventions

Technosphere Insulin

2 unit

Technosphere Insulin

4, 8, 12 units

Basal insulin

subcutaneously-injected basal insulin

Primary outcome measure

  • Percentage of participants with Continuous Glucose Meter (CGM) measured time in range (TIR) ≥70% [ Time Frame: 13 weeks ]

Central Contacts and Locations

Central contacts

Jennifer Pleitez

818-661-5032jpleitez@mannkindcorp.com

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Pamela Parcon

323-203-8744pparcon@chla.usc.edu

Principal Investigator:

Roshi Monzavi, MD

University of California San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

Avani Narayan

415-530-8047Avani.Narayan@ucsf.edu

Principal Investigator:

Laya Ekhlaspour, MD

Barbara Davis Center for Diabetes Young Adult Clinic

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Cari Berget

303-724-8977cari.berget@cuanschutz.edu

Principal Investigator:

Gregory Forlenza, MD

Yale University

Recruiting

New Haven, Connecticut, United States, 06511

Contacts

Amy Steffen, BSN

203-737-8852Amy.steffen@yale.edu

Principal Investigator:

Jennifer Sherr, MD

University of Florida

Recruiting

Gainsville, Florida, United States, 32610

Contacts

Sarah Peeling

352-273-5275smpeeling@peds.ufl.edu

Principal Investigator:

Brittany Bruggeman, MD

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Sana Kalaji

317-274-0306skalaji@iu.edu

Principal Investigator:

Linda DiMeglio, MD

Joslin Diabetes Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Kerry Milaszewski

617-975-8209Kerry.Milaszewski@joslin.harvard.edu

Principal Investigator:

Lori Laffel, MD

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Deidre Graham, RN

405-271-8001deidre-graham@ou.edu

Principal Investigator:

David Sparling, MD

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Anh Nguyen

832-822-3870anh.nguyen2@bcm.edu

Principal Investigator:

Daniel DeSalvo, MD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Sara Prince

434-320-5599SP4SA@uvahealth.org

Principal Investigator:

Melissa Schoelwer, MD

More Information

Sponsor

Mannkind Corporation

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Keywords

  • Diabetes Mellitus
  • Insulin
  • Inhaled
  • Afrezza
  • Technosphere
  • Pediatric
  • Inhaled Insulin
  • Type 1 Diabetes
  • Newly diagnosed type 1 diabetes
  • Technosphere Insulin
  • rapid-acting inhaled insulin
  • Meal-time inhaled insulin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Mannkind Corporation on 2026-08-13.