Pulmonary function changes related to acute and chronic administration of inhaled insulin.

The need for frequent insulin injections to achieve optimal glycemic control remains a major barrier to initiating and maintaining insulin therapy in diabetes. The inhaled route of insulin administration offers many potential advantages. However, there are ongoing concerns regarding the pulmonary safety of inhaled insulin. Published studies reporting pulmonary safety and data submitted to the Food and Drug Administration were reviewed. All studies were open-label, included adult subjects with type 1 and 2 diabetes, and excluded patients with underlying lung disease. Inhaled insulin was compared with subcutaneous insulin and oral agents. Inhaled insulin is associated with small, consistent reductions in lung function, primarily forced expiratory volume in 1 s (FEV(1)) and diffusion capacity for carbon monoxide (DL(CO)). The small reductions in lung function occurred early (within 12 weeks) and did not progress over time. The magnitudes of the reductions were 30-50 mL for FEV(1) and 0.5-1.0 standard units for DL(CO). Collectively, the data indicate that inhaled insulin is safe in studies with duration up to 4 years. The Food and Drug Administration requires monitoring of lung function on a regular basis.