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NCT04974528 · ClinicalTrials.gov registry record · Phase 3
Afrezza® INHALE-1 Study in Pediatrics
A Phase 3 study of Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, sponsored by Mannkind Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 319
- Enrollment target
- 20
- Study locations
NCT04974528 is a Phase 3 study of Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1 that has completed, run by Mannkind Corporation. The registered enrollment target is 319 participants, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT04974528, a Phase 3 study of Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, has completed, sponsored by Mannkind Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 319 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 319 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (93% lower). The listed sponsor is Mannkind Corporation, which has 42 total studies on file at ClinicalTrials.gov.
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.
NCT04974528 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Iowa.
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.
What interventions are being tested in trial NCT04974528?
The interventions under investigation include: Afrezza (BIOLOGICAL), Rapid-acting Insulin Analog (BIOLOGICAL), Basal Insulin (BIOLOGICAL).
Who is sponsoring clinical trial NCT04974528?
This trial is sponsored by Mannkind Corporation, which has 42 total clinical trials registered on ClinicalTrials.gov.
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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.