Treatment safety and efficacy of inhaled insulin (AERx® iDMS 1) compared with subcutaneous insulin therapy in patients with type 1 diabetes: 1-year data from a randomized, parellel group trial

Abstract

Aims: Assessment of the long-term safety and efficacy of liquid inhaled insulin via AERx® insulin Diabetes Management System (iDMS) in a basal/bolus treatment regimen of adults with Type 1 diabetes. Methods: Patients were randomized 2 : 1 to prandial inhaled (n = 205) or subcutaneous (s.c.) (n = 99) insulin, plus one/two daily injections of neutral protamine Hagedorn (NPH) insulin for 12 months. The primary endpoints were pulmonary function tests (PFT) and baseline changes in chest X-rays at 12 months. Safety and efficacy assessments were measured at regular intervals. Results: PFTs after 12 months were comparable between the groups, except for reduced per cent of predicted carbon monoxide l..