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Researchers to share early INHALE-3 data on efficacy of basal insulin plus inhaled insulin for type 1 diabetes

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A Scientific Sessions symposium will feature a panel of investigators who will share findings from the INHALE-3 randomized trial, which compared the effectiveness and safety of an insulin regimen consisting of basal insulin (degludec) plus inhaled insulin (Afrezza) and continuous glucose monitoring (CGM) versus usual care and CGM in adults with type 1 diabetes.

Irl B. Hirsch, MD
Irl B. Hirsch, MD

The Efficacy and Safety of Inhaled Insulin Used with Insulin Degludec Compared with Automated Insulin Delivery or Multiple Daily Insulin Injections in Adults with Type 1 Diabetes—Results of the INHALE-3 Randomized Trial will take place on Saturday, June 22, from 8:00 a.m. – 9:30 a.m. ET in Room W320, the Chapin Theater, of the Orlando Convention Center. The symposium also will be livestreamed on the virtual meeting platform for registered meeting participants and will be available on-demand following the 84th Scientific Sessions.

“With INHALE-3, the question is whether we can achieve improved mealtime glycemic control in people with type 1 diabetes with degludec plus Afrezza, as well as benefits regarding secondary glucometric endpoints, such as time in range, time below range, etc.,” said INHALE-3 Study Chair Irl B. Hirsch, MD, Professor and Diabetes Treatment and Teaching Chair at the University of Washington (UW) School of Medicine and UW Medicine Diabetes Institute.

Although results from INHALE-3 are pending, Dr. Hirsch noted that a previously reported study demonstrated that patients taking Afrezza had significantly reduced postprandial spikes in blood glucose.

“One of the things that is very interesting about INHALE-3 is that the participants randomized to the control arm had the opportunity at the end of the study to use the Afrezza in an observation arm for 13 weeks. I think it will be very telling to see how many of them are going to want to stay on Afrezza,” Dr. Hirsch said. “We will see what the results show, but I hope it will inform clinicians who are not familiar with this insulin that, for the right person, it may be a very good option for insulin delivery.”

In this Phase 4, randomized controlled trial, approximately 120 participants with type 1 diabetes using multiple daily injections, an automated insulin delivery system or a pump without automation, and CGM were randomly assigned to an insulin regimen of insulin degludec plus inhaled insulin Afrezza and CGM or continuation of usual care. The primary outcome of the trial was at 17 weeks, followed by a 13-week extension phase in which participants in both groups used the degludec-inhaled insulin regimen.

The study results will be presented in three parts.

Ruth S. Weinstock, MD, PhD, SUNY Upstate Medical University, will discuss the comparison of inhaled insulin versus rapid-acting analogue insulin in trial participants who use automated insulin delivery or multiple daily insulin injections during standardized in-clinic meal challenges.

Grazia Aleppo, MD, FACE, FACP, Northwestern University, Feinberg School of Medicine, will review the effect of inhaled insulin degludec compared to automated insulin delivery and in subgroups.

Carol J. Levy, MD, CDCES, Icahn School of Medicine at Mount Sinai, will provide an overview of the primary efficacy, safety, and quality-of-life outcomes.

Dr. Hirsch will provide a critique of the study design and results.

Additionally, Halis K. Akturk, MD, Barbara Davis Center for Diabetes, will discuss the history of inhaled insulin and the study rationale. Yogish C. Kudva, MD, Mayo Clinic, will discuss study methods and the baseline characteristics of participants. Thomas Blevins, MD, Texas Diabetes and Endocrinology, will present data on the use of inhaled insulin in clinical practice.

Register Today for the 84th Scientific Sessions


Join us in Orlando for the 84th Scientific Sessions, June 21-24. Full in-person registration includes access to all of the valuable onsite content during the meeting and on-demand access to the virtual program June 25-Aug. 26. For those unable to join us in-person, we are planning a virtual program to allow as many people as possible to participate and learn about the latest advances in diabetes research, prevention, and care.