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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: Completed Phase 3 study of Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, sponsored by Mannkind Corporation.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Change in HbA1c from baseline to Week 26, for noninferiority assessment

Conditions Studied

Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1

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

FieldValue
Enrollment Target 319 participants
Start Date 2021-09-29
Est. Completion 2025-04-29
Phase Phase 3
Mannkind Corporation

42 total trials

What the finished NCT04974528 record still lists

NCT04974528 is an interventional study that assigns participants to a tested intervention. The registered 319 participants enrollment target is mid-sized for trials with a published cap, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (93% lower).

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 names 20 study sites across 10 states, led by 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.

Learn More About Clinical Trials

Similar trials for Diabetes Mellitus, Type 2

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04974528's enrollment target sits among peer trials

319 116th of 348 higher than 233 of 348 other Diabetes Mellitus, Type 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04974528, the US trial registry maintained by the National Library of Medicine. NCT04974528 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.