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INHALE-3: Afrezza® Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Diabetes

NCT05904743 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2024-08-09

No results posted yet for this study

Summary

INHALE-3 is a Phase 4, randomized controlled trial (RCT) that will randomly assign participants ≥18 years of age with type 1 diabetes (T1D) using multiple daily injections (MDI), an automated insulin delivery (AID) system, or a pump without automation, and continuous glucose monitoring (CGM) 1:1 to an insulin regimen of insulin degludec plus inhaled insulin (Afrezza) and CGM or continuation of usual care. The primary outcome of the RCT is at 17 weeks. The RCT will be followed by a 13-week extension phase in which participants in both groups will use the degludec-inhaled insulin regimen.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

BIOLOGICAL

Afrezza

Pharmaceutical form: powder Route of administration: inhalation

BIOLOGICAL

insulin degludec

Pharmaceutical form: solution for injection Route of administration: subcutaneous

BIOLOGICAL

Rapid-acting Insulin Analog

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

BIOLOGICAL

Basal Insulin

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

Sponsors & Collaborators

  • Jaeb Center for Health Research

    collaborator OTHER

  • Mannkind Corporation

    lead INDUSTRY

Principal Investigators

  • Kevin Kaiserman, MD · Mannkind Corporation

  • Irl B. Hirsch, MD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-07
Primary Completion
2024-03-26
Completion
2024-06-24
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 NCT05904743 on ClinicalTrials.gov