Safety and Efficacy of AIR Inhaled Insulin Compared with Subcutaneous Insulin in Patients Having Diabetes and Asthma: A 12-Month, Randomized, Noninferiority Trial

Abstract Background: Long-term safety and efficacy of AIR® inhaled insulin (Eli Lilly and Co., Indianapolis, IN) (AIR is a registered trademark of Alkermes, Inc., Cambridge, MA) in patients with diabetes and concomitant lung disease remain to be established. Methods: This 1-year, randomized, open-label, active comparator, two-arm, parallel study compared the safety and efficacy of AIR insulin to subcutaneous (SC) insulin in patients having type 1 or type 2 diabetes and asthma. Patients with type 2 diabetes continued taking their prestudy oral antihyperglycemic medication. Results: Change in hemoglobin A1C from baseline to end point was similar for the AIR insulin and SC insulin groups (−0.063 ± 0.128% and −0.315 ± 0.128% respectively, P = 0.105), but noninferiority failed to be achieved (the upper limit of the 95% confidence interval [−0.053, 0.555] was >0.4%). The total daily prandial dose increased more in the AIR insulin group than in the SC insulin group (0.150 U/kg and 0.044 U/kg, respectively, P = 0...