Initiation of prandial insulin therapy with AIR inhaled insulin or insulin lispro in patients with type 2 diabetes: A randomized noninferiority trial.

Abstract Background: Insulin initiation in patients with type 2 diabetes is often delayed because of concerns about injections. Our objective was to compare the effects of AIR® inhaled insulin (Eli Lilly and Co., Indianapolis, IN) (AIR is a registered trademark of Alkermes, Inc., Cambridge, MA) with those of injectable insulin on glycemic control and safety. Methods: This was planned as a 24-month, open-label, randomized study in adults with diabetes inadequately controlled by one or more oral antihyperglycemic medications (OAMs). Following a 2-week baseline period, patients continued OAMs and were randomized to AIR insulin (n = 208) or insulin lispro (n = 203) before meals. The primary end point was hemoglobin A1C (A1C) change from baseline to 6 months. Noninferiority was established if the upper limit of the 95% confidence interval of the difference in A1C change was ≤0.4%. Results: Early termination of the study diminished the number of patients for the 12- and 24-month analyses, but not for the primar...