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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Mannkind Corporation
Study ID
NCT07224321
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Technosphere Insulin — DRUG
    2 unit
  • Technosphere Insulin — DRUG
    4, 8, 12 units
  • Basal insulin — DRUG
    subcutaneously-injected basal insulin

Study Details

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 10 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.

Key Dates

Start date
Feb 4, 2026
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027
Pamela Parcon
[email protected]
323-203-8744
Roshi Monzavi, MD (PRINCIPAL_INVESTIGATOR)
University of California San FranciscoSan FranciscoCalifornia94158
Avani Narayan
[email protected]
415-530-8047
Laya Ekhlaspour, MD (PRINCIPAL_INVESTIGATOR)
Barbara Davis Center for Diabetes Young Adult ClinicAuroraColorado80045
Cari Berget
[email protected]
303-724-8977
Gregory Forlenza, MD (PRINCIPAL_INVESTIGATOR)
Yale UniversityNew HavenConnecticut06511
Amy Steffen, BSN
[email protected]
203-737-8852
Jennifer Sherr, MD (PRINCIPAL_INVESTIGATOR)
University of FloridaGainesvilleFlorida32610
Sarah Peeling
[email protected]
352-273-5275
Brittany Bruggeman, MD (PRINCIPAL_INVESTIGATOR)
Indiana UniversityIndianapolisIndiana46202
Sana Kalaji
[email protected]
317-274-0306
Linda DiMeglio, MD (PRINCIPAL_INVESTIGATOR)
Joslin Diabetes CenterBostonMassachusetts02215
Kerry Milaszewski
[email protected]
617-975-8209
Lori Laffel, MD (PRINCIPAL_INVESTIGATOR)
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104
Deidre Graham, RN
[email protected]
405-271-8001
David Sparling, MD (PRINCIPAL_INVESTIGATOR)
Baylor College of MedicineHoustonTexas77030
Anh Nguyen
[email protected]
832-822-3870
Daniel DeSalvo, MD (PRINCIPAL_INVESTIGATOR)
University of VirginiaCharlottesvilleVirginia22903
Sara Prince
[email protected]
434-320-5599
Melissa Schoelwer, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Children's Hospital Los Angeles· Los Angeles, CAUniversity of California San Francisco· San Francisco, CABarbara Davis Center for Diabetes Young Adult Clinic· Aurora, COYale University· New Haven, CTUniversity of Florida· Gainesville, FLIndiana University· Indianapolis, IN

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