Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Afrezza® INHALE-1 Study in Pediatrics
NCT04974528 · View on ClinicalTrials.gov ↗
Study Summary
INHALE-1 is a Phase 3, open-label, randomized clinical study evaluating the efficacy and safety of Afrezza in combination with a basal insulin (i.e., the Afrezza group) versus insulin aspart, insulin lispro or insulin glulisine in combination with a basal insulin (i.e., the Rapid-acting Insulin Analog \[RAA\] injection group) in pediatric subjects with type 1 or type 2 diabetes mellitus. Following 26 weeks of randomized treatment (i.e., Afrezza or RAA injection combined with a basal insulin), all subjects will enter a treatment extension where subjects will receive Afrezza until Week 52. The purpose of the treatment extension is to assess safety and efficacy with continued use of Afrezza. Pediatric subjects ≥4 and \<18 years of age will be enrolled in this study. Subjects will be randomly assigned in a 1:1 ratio to either the Afrezza group or the RAA injection group. The study is composed of: * Up to 5-week screening/run-in period * 26 week randomized treatment period * 26-week treatment extension * 4-week follow-up period
Conditions Studied
Interventions
- BIOLOGICAL Afrezza
- BIOLOGICAL Rapid-acting Insulin Analog
- BIOLOGICAL Basal Insulin
Study Locations (20)
California
- Children's Hospital Los Angeles — Los Angeles
- Children's Hospital of Orange County — Orange
- Stanford University — Palo Alto
- Sutter Institute for Medical Research (formerly Center of Excellence in Diabetes and Endocrinology) — Sacramento
- University of California San Diego, Rady Children's Hospital — San Diego
- University of California San Francisco — San Francisco
Florida
- University of Florida — Gainesville
- Joe DiMaggio Children's Hospital — Hollywood
- Advent Health Orlando — Orlando
- University of South Florida — Tampa
Iowa
- University of Iowa — Iowa City
- Iowa Diabetes Research, IDR — West Des Moines
Maryland
- Dr. Barry J. Reiner — Baltimore
- Johns Hopkins University — Baltimore
Connecticut
- Yale New Haven Hospital — New Haven
Delaware
- Nemours Children's Hospital, Delaware — Wilmington
Georgia
- Emory University, Children's Healthcare of Atlanta — Atlanta
Idaho
- Rocky Mountain Clinical Research — Idaho Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 319 participants |
| Start Date | 2021-09-29 |
| Est. Completion | 2025-04-29 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04974528
The ClinicalTrials.gov registry entry for NCT04974528 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 319 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mannkind Corporation, which has 39 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 3 interventions — of which Afrezza is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04974528 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Iowa. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04974528 about?
NCT04974528 is a clinical study titled "Afrezza® INHALE-1 Study in Pediatrics". INHALE-1 is a Phase 3, open-label, randomized clinical study evaluating the efficacy and safety of Afrezza in combination with a basal insulin (i.e., the Afrezza group) versus insulin aspart, insulin lispro or insulin glulisine in combination with a basal insulin (i.e., the Rapid-acting Insulin Anal...
What is the current status of trial NCT04974528?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 319 participants. The study started on 2021-09-29. Estimated completion is 2025-04-29.
What conditions does trial NCT04974528 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04974528?
The interventions under investigation include: Afrezza (BIOLOGICAL), Rapid-acting Insulin Analog (BIOLOGICAL), Basal Insulin (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04974528?
This trial is sponsored by Mannkind Corporation, which has 39 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04974528 being conducted?
This trial has 20 study locations across California, Connecticut, Delaware, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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