Afrezza + Insulin Degludec for Type 1 Diabetes

Recruiting in Palo Alto (17 mi)

+18 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Mannkind Corporation

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Irl B. Hirsch, MD

Principal Investigator

University of Washington

Kevin Kaiserman, MD

Principal Investigator

Mannkind Corporation

Eligibility Criteria

Adults over 18 with Type 1 Diabetes using multiple daily injections, an automated insulin delivery system, or a pump without automation and continuous glucose monitoring. They must be on a stable insulin regimen for at least 3 months, not have used inhaled insulin recently, and have no conditions that could affect safety or compliance.

Inclusion Criteria

I am willing to undergo pregnancy tests if I can have children.

No medical, psychiatric, or other conditions, or medications being taken that in the Investigator's judgment would be a safety concern for participation in the study. This includes considering the potential impact of medical conditions known to be present including cardiovascular, liver, kidney disease, thyroid disease, adrenal disease, malignancies, vision difficulties, active proliferative retinopathy, and other medical conditions; psychiatric conditions including eating disorders; drug or alcohol abuse

I have been using insulin for at least 6 months.

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Exclusion Criteria

Exposure to any investigational product(s), including drugs or devices, in the 90 days prior to the start of screening

I only have diabetes or no other conditions affecting my blood sugar levels.

I've had a severe low blood sugar or DKA episode in the last 3 months.

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Treatment Details

Interventions

Afrezza (Insulin)
Basal Insulin (Insulin)
Insulin degludec (Insulin)
Rapid-acting Insulin Analog (Insulin)

Trial OverviewThe INHALE-3 trial is testing if combining Afrezza (inhaled insulin) with long-acting basal insulin degludec improves blood sugar control compared to usual care in adults with Type 1 Diabetes. Participants will either continue their current treatment or switch to the new combination for a total of 30 weeks.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Afrezza (Technosphere Insulin) + insulin degludecExperimental Treatment2 Interventions

The Afrezza-Degludec group will inhale Afrezza at meals and corrections and will inject insulin degludec once a day for the 17 weeks of the RCT Phase. Dexcom Continuous Glucose Monitoring (CGM) will be provided. The Afrezza-Degludec group will continue to use Afrezza and insulin degludec for an additional 13 weeks in the Extension Phase.

Group II: Usual Care: Insulin delivery with either MDI, a pump without automation, or an AID system and CGMActive Control2 Interventions

The Usual Care group will continue to receive insulin as they did before the study. This could be by multiple daily injections (MDI) or by using an insulin pump with or without automation for the 17 weeks of the randomized controlled trial (RCT) Phase. Participants will continue to use their personal continuous glucose monitor (CGM) as they did before the study. The Usual Care group will then use Afrezza and insulin degludec for 13 weeks in the Extension Phase. Dexcom CGM will be provided during the Extension Phase.