INHALE-3: Afrezza® Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Diabetes
Public ClinicalTrials.gov record NCT05904743. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
INHALE-3: A 17-Week Randomized Trial and a 13-Week Extension, Evaluating the Efficacy and Safety of Inhaled Insulin (Afrezza) Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Diabetes
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05904743
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 141 participants
Conditions and interventions
Conditions
Interventions
- Afrezza Biological
- insulin degludec Biological
- Rapid-acting Insulin Analog Biological
- Basal Insulin Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 7, 2023 (Actual)
- Primary completion
- Mar 26, 2024 (Actual)
- Completion
- Jun 24, 2024 (Actual)
- Last update posted
- Aug 9, 2024
2023 – 2024
United States locations
- U.S. sites
- 19
- U.S. states
- 13
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Loma Linda University-Diabetes Treatment Center | Loma Linda | California | 92354 | — |
| Sansum Diabetes Research | Santa Barbara | California | 93105 | — |
| Barbara Davis Center | Aurora | Colorado | 80045 | — |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | — |
| Northwestern University Division of Endocrinology, Metabolism and Molecular Medicine | Chicago | Illinois | 60611 | — |
| Iowa Diabetes Research | West Des Moines | Iowa | 50265 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Las Vegas Endocrinology | Henderson | Nevada | 89074 | — |
| Endocrine Associate of West Village, PC | Long Island City | New York | 11106 | — |
| Mount Sinai Diabetes Center | New York | New York | 10075 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | — |
| Texas Diabetes & Endocrinology, P.A. | Austin | Texas | 78731 | — |
| The University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Diabetes and Glandular Disease Clinic, P.A. | San Antonio | Texas | 78229 | — |
| University of Washington Diabetes Institute | Seattle | Washington | 98119 | — |
| Mountain State Diabetes | Parkersburg | West Virginia | 26101 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05904743, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 9, 2024 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05904743 live on ClinicalTrials.gov.