First approved inhaled insulin therapy for diabetes mellitus.

The long-term benefits of tight glycemic control in preventing microvascular and macrovascular complications are well established in both Type 1 diabetes mellitus (Type 1 DM) and Type 2 diabetes mellitus (Type 2 DM). Nonetheless, achievement of recommended haemoglobin A1c (HbA(1c)) goals (< or = 6.5 - 7.0%) has remained elusive, especially in patients with diabetes who require insulin therapy. Delayed/suboptimal titration of insulin is partly related to poor acceptance of multiple injection regimen by both physicians and patients. EXUBERA (human insulin [rDNA origin]; Pfizer), the first approved inhaled insulin for the treatment of diabetic patients, has been shown to be safe and as effective as regular/rapidly acting insulin in improving glycemic control. In addition to controlling postprandial glucose excursions, EXUBERA exerts a major action to reduce fasting plasma glucose (FPG) concentration. Thus, it has the potential to be used as a monotherapy in Type 2 DM, as well as in combination with an insulin sensitizer in Type 2 DM or in combination with long-acting insulin in both Type 2 DM and Type 1 DM.