Inhaled Insulin Shows Promise in Enhancing Type 1 Diabetes Management: INHALE-3 Trial
USA: Results from INHALE-3, a clinical trial investigating inhaled insulin in adults with type 1 diabetes, demonstrated its safety and efficacy in improving glycemic control. These findings suggest that inhaled insulin could serve as a viable alternative to traditional insulin delivery methods, offering potential benefits for patients seeking enhanced diabetes management options. The study, presented at the American Diabetes Association (ADA) annual meeting.on June 22, highlights significant insights into using this novel insulin formulation.
Dr. Irl B. Hirsch, the Study Chair from the University of Washington School of Medicine, emphasized the study's implications, stating, "Our findings indicate that inhaled insulin may benefit patients actively engaged in diabetes self-care, aiming to further reduce hyperglycemia or seeking an alternative to insulin pumps."
INHALE-3, classified as a Phase 4 randomized controlled trial, enrolled around 120 participants with type 1 diabetes using various insulin delivery methods and continuous glucose monitoring. Participants were assigned to either receive a regimen of insulin degludec combined with inhaled insulin Afrezza and CGM or continue with their usual care.
The study revealed that a higher percentage of participants using the inhaled insulin regimen achieved significant improvements in A1C levels compared to those continuing with standard care. Specifically, 21 percent of the inhaled insulin group achieved an A1C improvement exceeding 0.5 percent, contrasting with only 5 percent in the standard care group.
"Crucially, among participants starting with an A1C above 7 percent, none in the standard care group achieved levels below 7 percent by the end of the study, while 21 percent in the inhaled insulin group did," noted Dr. Hirsch.
The primary trial endpoint was assessed at 17 weeks, followed by a 13-week extension phase where both groups utilized the degludec-inhaled insulin regimen. These findings underscore the potential of inhaled insulin as a beneficial addition to diabetes management strategies, offering patients a promising alternative for achieving improved glycemic control.
Moving forward, further research and clinical evaluation will be essential to fully elucidate the long-term benefits and optimal utilization of inhaled insulin in managing type 1 diabetes.
The primary focus of the study was the change in A1C levels, with secondary endpoints including alterations in time-in-range (TIR) and hypoglycemia monitored through continuous glucose monitoring (CGM), along with patient-reported outcomes assessing satisfaction with insulin delivery.
Furthermore, the research highlighted that 19 percent of participants who transitioned from an automated insulin delivery (AID) system to a combination of inhaled insulin and degludec achieved an A1C improvement exceeding 0.5 percent. Conversely, within the inhaled insulin group, 26 percent experienced a decline in A1C greater than 0.5 percent compared to 3 percent in the standard care group, illustrating the variability in response to inhaled insulin therapy.
Dr. Irl B. Hirsch emphasized the individualized nature of insulin therapy, stating, "It's clear that inhaled insulin isn't universally suitable for everyone. Understanding the appropriate dosing of basal and inhaled insulin is crucial for optimizing outcomes."
Summarizing the symposium, Dr. Thomas Blevins of Texas Diabetes and Endocrinology reflected on the study's insights and potential implications for clinical practice. "INHALE-3 provided valuable lessons. Inhaled insulin excels in controlling postprandial spikes, offers rapid action and clearance to minimize insulin stacking, and boasts discreet and convenient administration."
However, Dr. Blevins cautioned against its use in patients with chronic pulmonary conditions like asthma or COPD or those hypersensitive to regular insulin. He stressed the importance of baseline and regular pulmonary function tests, including spirometry, even in asymptomatic patients initiating inhaled insulin therapy.
Looking ahead, Dr. Blevins underscored the need for refined guidelines and optimal practices in utilizing inhaled insulin, highlighting the role of shared decision-making between patients and healthcare providers in determining the suitability of this therapy.
As research continues to evolve, ongoing evaluation and adaptation of protocols will be essential to maximize the benefits of inhaled insulin while ensuring patient safety and satisfaction in managing type 1 diabetes.
Reference:
Beck RW, et al "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" ADA 2024.
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