Clinical trialNCT07224321RecruitingPhase 2Interventional

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

SponsorMannkind CorporationEnrollment100Type 1 Diabetes Mellitus

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

No overall officials are registered on this study record. Site-level investigators, where published, appear with their sites below. Why? →

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

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

United States

Children'S Hospital Los Angeles
Los Angeles, California, United States
Roshi Monzavi, MD
Recruiting
University of California San Francisco
San Francisco, California, United States
Laya Ekhlaspour, MD
Recruiting
Barbara Davis Center for Diabetes Young Adult Clinic
Aurora, Colorado, United States
Gregory Forlenza, MD
Recruiting
Yale University
New Haven, Connecticut, United States
Jennifer Sherr, MD
Recruiting
University of Florida
Gainsville, Florida, United States
Brittany Bruggeman, MD
Recruiting
Indiana University
Indianapolis, Indiana, United States
Linda DiMeglio, MD
Recruiting
Joslin Diabetes Center
Boston, Massachusetts, United States
Lori Laffel, MD
Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
David Sparling, MD
Recruiting
Baylor College of Medicine
Houston, Texas, United States
Daniel DeSalvo, MD
Recruiting
University of Virginia
Charlottesville, Virginia, United States
Melissa Schoelwer, MD
Recruiting

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.

Basal insulinTechnosphere Insulin

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: 4 Feb 2026
Primary completion: 31 Mar 2027
Completion: 30 Sept 2027
Last update posted: 13 Aug 2026
Registered enrollment: 100
Registry id: NCT07224321

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.