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

Part of paid clinical trials in Loma Linda, California.

Sponsor
Mannkind Corporation
Study ID
NCT05904743
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Afrezza — BIOLOGICAL
    Pharmaceutical form: powder Route of administration: inhalation
  • insulin degludec — BIOLOGICAL
    Pharmaceutical form: solution for injection Route of administration: subcutaneous
  • Rapid-acting Insulin Analog — BIOLOGICAL
    Pharmaceutical form: clear and colorless solution for injection Route of administration: subcutaneous
  • Basal Insulin — BIOLOGICAL
    Pharmaceutical form: clear and colorless solution for injection Route of administration: subcutaneous

Study Details

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.

Key Dates

Start date
Jul 7, 2023
Status verified
Aug 2024
Primary completion
Mar 26, 2024
Completion
Jun 24, 2024

Study Design

Enrollment
141 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Afrezza (Technosphere Insulin) + insulin degludec
    The Afrezza-Degludec group will inhale Afrezza at meals and corrections and will inject insulin degludec once a day for the 17 weeks of the RCT Phase. Dexcom Continuous Glucose Monitoring (CGM) will be provided. The Afrezza-Degludec group will continue to use Afrezza and insulin degludec for an additional 13 weeks in the Extension Phase.
  • Active Comparator: Usual Care: Insulin delivery with either MDI, a pump without automation, or an AID system and CGM
    The Usual Care group will continue to receive insulin as they did before the study. This could be by multiple daily injections (MDI) or by using an insulin pump with or without automation for the 17 weeks of the randomized controlled trial (RCT) Phase. Participants will continue to use their personal continuous glucose monitor (CGM) as they did before the study. The Usual Care group will then use Afrezza and insulin degludec for 13 weeks in the Extension Phase. Dexcom CGM will be provided during the Extension Phase.

Primary Outcome Measure

Change in glycated hemoglobin (HbA1c) [ Time Frame: 17 weeks ]

Locations (19)

FacilityCityStateZIPSite coordinators
Loma Linda University-Diabetes Treatment CenterLoma LindaCalifornia92354-
Sansum Diabetes ResearchSanta BarbaraCalifornia93105-
Barbara Davis CenterAuroraColorado80045-
Atlanta Diabetes AssociatesAtlantaGeorgia30318-
Northwestern University Division of Endocrinology, Metabolism and Molecular MedicineChicagoIllinois60611-
Iowa Diabetes ResearchWest Des MoinesIowa50265-
Boston Medical CenterBostonMassachusetts02118-
Joslin Diabetes CenterBostonMassachusetts02215-
Mayo ClinicRochesterMinnesota55905-
Las Vegas EndocrinologyHendersonNevada89074-
Endocrine Associate of West Village, PCLong Island CityNew York11106-
Mount Sinai Diabetes CenterNew YorkNew York10075-
SUNY Upstate Medical UniversitySyracuseNew York13210-
University of North Carolina at Chapel HillChapel HillNorth Carolina27514-
Texas Diabetes & Endocrinology, P.A.AustinTexas78731-
The University of Texas Southwestern Medical CenterDallasTexas75390-
Diabetes and Glandular Disease Clinic, P.A.San AntonioTexas78229-
University of Washington Diabetes InstituteSeattleWashington98119-
Mountain State DiabetesParkersburgWest Virginia26101-

Find similar trials in Loma Linda, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Loma Linda University-Diabetes Treatment Center· Loma Linda, CASansum Diabetes Research· Santa Barbara, CABarbara Davis Center· Aurora, COAtlanta Diabetes Associates· Atlanta, GANorthwestern University Division of Endocrinology, Metabolism and Molecular Medicine· Chicago, ILIowa Diabetes Research· West Des Moines, IA

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