Inhaled insulin noninferior to usual care, industry trial in type 1 diabetes finds
Patients who began using inhaled insulin were more likely to have an improvement or worsening in their HbA1c level than patients who continued their existing insulin regimens, but overall glycemic control was similar with either strategy, a randomized trial found.
Overall HbA1c control was similar in patients switching to a regimen that included inhaled Technosphere insulin compared to those continuing current insulin delivery methods, a trial found.
The trial, funded by the inhaled insulin manufacturer, included adults with type 1 diabetes from 19 sites. They were randomized to inhaled insulin plus insulin degludec (n=62) or continuation of their pre-study insulin delivery method (n=61) for 17 weeks. The pre-study regimen was an automated insulin delivery system in 48% of patients and multiple daily insulin injections in 45%. Results were published by Diabetes Care on Dec. 6.
Mean HbA1c levels went from 7.57% at baseline to 7.62% at 17 weeks in the inhaled insulin group and from 7.59% to 7.54% in the continuation group (adjusted difference, 0.11% [95% CI, −0.10% to 0.33%]; P=0.01 for noninferiority). The inhaled insulin group showed more change in their HbA1c levels: 21% had an improvement of at least 0.5% and 26% had a worsening of at least 0.5%, compared to 5% and 3%, respectively, in the continuation group. The most common side effect of inhaled insulin was a brief cough; eight participants in that group discontinued due to side effects.
The study authors concluded that “while the study results support consideration of [inhaled insulin] as a viable option for patients with type 1 diabetes, patient selection with respect to prescribing [inhaled insulin] is important.” Overnight hyperglycemia was more common in the inhaled insulin group, possibly due to underdosing at dinner that was not corrected later, they observed.
Successful use of inhaled insulin requires good self-management and frequent inhalation during the day and evening, the study authors noted. “When this is done, substantial glycemic improvement is possible even in switching from an [automated insulin delivery] system. However, when this is not the case, there can be glycemic worsening as observed in a subset of study participants.” The authors called for additional research to determine which patients would benefit from inhaled insulin and what dosing strategies are optimal.