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

ClinicalTrials.gov ID

NCT07224321

Lead Sponsor

Mannkind CorporationINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

100Estimated

Last Update Posted

Aug 13, 2026Actual

Start Date

Feb 4, 2026Actual

Primary Completion Date

Mar 2027Estimated

Completion Date

Sep 2027Estimated

Official Title

INHALE-1st: Technosphere Insulin (Afrezza®) In Combination With Basal Insulin For Youth With Newly-Diagnosed Type 1 Diabetes

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.

• Type 1 Diabetes Mellitus

• Technosphere Insulin
• Basal insulin

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Mannkind CorporationINDUSTRY

Collaborators

Jaeb Center for Health ResearchOTHER

Amy.steffen@yale.edu203-737-8852

skalaji@iu.edu317-274-0306

anh.nguyen2@bcm.edu832-822-3870

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