The commercial failure of Exubera- (Pfizer, New York, NY), the first inhaled insulin product to come to market, led other companies such as Eli Lilly-Alkermes to halt studies of similar drug delivery in development intended to compete for a share of the lucrative diabetes market. Does this signal defeat for efforts to deliver insulin via the lungs? The science and circumstances behind the Lilly-Alkermes decision to discontinue trials of the AIR- inhaled insulin product are explored in a special supplement to Diabetes Technology & Therapeutics, a peer-reviewed journal published by Mary Ann Liebert, Inc. (www.liebertpub.com). The supplement is available free online at www.liebertpub.com/dia
The supplement presents the data on AIR inhaled insulin that has been made available by Eli Lilly (Indianapolis, IN) and Alkermes (Cambridge, MA), co-developers of the drug. Eight articles describe various protocols in which the effectiveness and safety of AIR were compared to traditional insulin injections in patients with type 1 or type 2 diabetes. These studies represent noninferiority trials, in which AIR was evaluated for its potential to be at least as safe and effective as subcutaneous (SC) insulin across a range of parameters.
Satish K. Garg, MD, Professor of Medicine and Pediatrics at the University of Colorado Denver, and Editor-in-Chief of Diabetes Technology & Therapeutics, and colleagues report the results of a 2-year Phase 3 trial conducted in 385 patients, in an article entitled, "Two-Year Efficacy and Safety of AIR Inhaled Insulin in Patients with Type 1 Diabetes: An Open-Label Randomized Controlled Trial." The study found AIR to be inferior to SC insulin (in a noninferiority clinical trial design) in its ability to maintain optimal blood glucose levels over time, based on measurements of glycosylated hemoglobin (HbA1c).