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Afrezza® INHALE-1 Study in Pediatrics

NCT04974528 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 319

Last updated 2025-05-06

No results posted yet for this 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

  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2

Interventions

BIOLOGICAL

Afrezza

Pharmaceutical form: powder Route of administration: inhalation

BIOLOGICAL

Rapid-acting Insulin Analog

Pharmaceutical form: clear and colorless solution for injection Route of administration: subcutaneous

BIOLOGICAL

Basal Insulin

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Sponsors & Collaborators

  • Jaeb Center for Health Research

    collaborator OTHER

  • Mannkind Corporation

    lead INDUSTRY

Principal Investigators

  • Kevin Kaiserman · Mannkind Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-29
Primary Completion
2024-10-03
Completion
2025-04-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04974528 on ClinicalTrials.gov