Afrezza® INHALE-1 Study in Pediatrics
Public ClinicalTrials.gov record NCT04974528. 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-1: A 26-week Primary Treatment Phase, With 26-week Extension, Open-label, Randomized Clinical Trial Evaluating the Efficacy and Safety of Afrezza® Versus Rapid-acting Insulin Analog Injections, Both in Combination With a Basal Insulin, in Pediatric Subjects With Type 1 or Type 2 Diabetes Mellitus
Study identification
- NCT ID
- NCT04974528
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Mannkind Corporation
- Industry
- Enrollment
- 319 participants
Conditions and interventions
Interventions
- Afrezza Biological
- Basal Insulin Biological
- Rapid-acting Insulin Analog Biological
Biological
Eligibility (public fields only)
- Age range
- 4 Years to 17 Years
- 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
- Sep 28, 2021
- Primary completion
- Oct 2, 2024
- Completion
- Apr 28, 2025
- Last update posted
- May 5, 2025
2021 – 2025
United States locations
- U.S. sites
- 39
- U.S. states
- 25
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Children's Hospital of Orange County | Orange | California | 92868 | — |
| Stanford University | Palo Alto | California | 94304 | — |
| Sutter Institute for Medical Research (formerly Center of Excellence in Diabetes and Endocrinology) | Sacramento | California | 95821 | — |
| University of California San Diego, Rady Children's Hospital | San Diego | California | 92123 | — |
| University of California San Francisco | San Francisco | California | 94158 | — |
| Yale New Haven Hospital | New Haven | Connecticut | 06511 | — |
| Nemours Children's Hospital, Delaware | Wilmington | Delaware | 19803 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| Joe DiMaggio Children's Hospital | Hollywood | Florida | 33021 | — |
| Advent Health Orlando | Orlando | Florida | 32803 | — |
| University of South Florida | Tampa | Florida | 33612 | — |
| Emory University, Children's Healthcare of Atlanta | Atlanta | Georgia | 30329 | — |
| Rocky Mountain Clinical Research | Idaho Falls | Idaho | 83404 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Iowa Diabetes Research, IDR | West Des Moines | Iowa | 50265 | — |
| University of Louisville, Norton Children's Hospital | Louisville | Kentucky | 40202 | — |
| Dr. Barry J. Reiner | Baltimore | Maryland | 21229 | — |
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | — |
| Michigan Pediatric Endocrine and Diabetes Services | Livonia | Michigan | 48152 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Children's Mercy Hospital | Kansas City | Missouri | 64111 | — |
| The DOCS | Las Vegas | Nevada | 89113 | — |
| Atlantic Health | Morristown | New Jersey | 07960 | — |
| UBMD Pediatrics Buffalo | Buffalo | New York | 14203 | — |
| NYU Langone, Hassenfeld Children's Hospital | New York | New York | 10016 | — |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Oklahoma Children's Hospital | Oklahoma City | Oklahoma | 73104 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| AM Diabetes and Endocrinology Center | Bartlett | Tennessee | 38133 | — |
| UT Southwestern | Dallas | Texas | 75390 | — |
| DHR Health | Edinburg | Texas | 78539 | — |
| Diabetes & Glandular Disease Clinic, DGD | San Antonio | Texas | 78229 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
| Seattle Children's | Seattle | Washington | 98105 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53201 | — |
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 NCT04974528, 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 May 5, 2025 · Synced May 16, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04974528 live on ClinicalTrials.gov.