Status and phase
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About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Ability to provide informed consent for study participation
Clinical diagnosis of T1D (per the Investigator)
Treatment with insulin for at least 6 months prior to the collection of the baseline continuous glucose monitoring (CGM) data
Same treatment regimen (MDI, an AID system, or an insulin pump without automation) for the 3 months prior to screening
Total daily insulin dose 20-100 units
Age ≥ 18 years
HbA1c <11.0%
Participant uses real-time CGM (any type of real-time CGM) on a regular basis (at least 70% of the time in the 4 weeks prior to screening)
No use of inhaled insulin in the 3 months prior to screening
If female of childbearing potential, willing and able to have pregnancy testing
Investigator believes that the participant can safely use the study treatment and will follow protocol
No medical, psychiatric,or other conditions, or medications being taken that in the Investigator's judgement would be a safety concern for participation in the study
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
141 participants in 2 patient groups
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Central trial contact
Johanna Ulloa; Jennifer Pleitez
Data sourced from clinicaltrials.gov
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