NCT05904743

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

INHALE-3: A 17-Week Randomized Trial and a 13-Week Extension, Evaluating the Efficacy and Safety of Inhaled Insulin (Afrezza) Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Diabetes

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Mannkind Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2023-07-07
• Primary completion: 2024-03-26
• Completion: 2024-06-24
• First posted: 2023-06-15
• Last updated: 2024-08-09

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study