Clinical trialNCT05904743CompletedPhase 4Interventional

INHALE-3: Afrezza® Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Diabetes

SponsorMannkind CorporationEnrollment141Diabetes Mellitus, Type 1

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

INHALE-3 is a Phase 4, randomized controlled trial (RCT) that will randomly assign participants ≥18 years of age with type 1 diabetes (T1D) using multiple daily injections (MDI), an automated insulin delivery (AID) system, or a pump without automation, and continuous glucose monitoring (CGM) 1:1 to an insulin regimen of insulin degludec plus inhaled insulin (Afrezza) and CGM or continuation of usual care. The primary outcome of the RCT is at 17 weeks. The RCT will be followed by a 13-week extension phase in which participants in both groups will use the degludec-inhaled insulin regimen.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Irl B. Hirsch, MD
University of Washington
Study ChairKOL profile →
clinicaltrials.gov ↗
Kevin Kaiserman, MD
Mannkind Corporation
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

19 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Loma Linda University-Diabetes Treatment Center
Loma Linda, California, United States
Sansum Diabetes Research
Santa Barbara, California, United States
Barbara Davis Center
Aurora, Colorado, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Northwestern University Division of Endocrinology, Metabolism and Molecular Medicine
Chicago, Illinois, United States
Iowa Diabetes Research
West Des Moines, Iowa, United States
Boston Medical Center
Boston, Massachusetts, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Las Vegas Endocrinology
Henderson, Nevada, United States
Endocrine Associate of West Village, Pc
Long Island City, New York, United States
Mount Sinai Diabetes Center
New York, New York, United States
Suny Upstate Medical University
Syracuse, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, United States
the University of Texas Southwestern Medical Center
Dallas, Texas, United States
Diabetes and Glandular Disease Clinic, P.A.
San Antonio, Texas, United States
University of Washington Diabetes Institute
Seattle, Washington, United States
Mountain State Diabetes
Parkersburg, West Virginia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Insulin, regular, human →Basal InsulinRapid-acting Insulin AnalogInsulin degludec →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 7 Jul 2023
Primary completion: 26 Mar 2024
Completion: 24 Jun 2024
Last update posted: 9 Aug 2024
Registered enrollment: 141
Registry id: NCT05904743

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.