OBJECTIVES: The objective of this study was to compare the rate of micro- and macrovascular complications in type 2 diabetes mellitus (T2DM) patients, from increased insulin use due to the addition of inhaled human insulin Exubera(EXU) as a treatment option versus subcutaneous (sc) insulin alone using the Economic Assessment of Glycemic Control and Long-term Effects(Eagle) model. METHODS: The model included uncontrolled T2DM patients eligible for insulin. Long-term consequences were based on risk equations derived from DCCT, UKPDS and WESDR. The model used Freemantle's estimates for year one. In the arm where EXU and sc insulin were available, 43% of patients initiated insulin therapy (35% inhaled and 8% sc insulin) versus 16% when only sc insulin was available. The subsequent yearly increase in insulin uptake was based on data from the DIN-LINK study. The model assumed 8% of patients remained on sc insulin. RESULTS: The mortality rate observed after 10 years was 34.5% versus 36.3% with inhaled and sc insulin versus sc insulin respectively. Complications observed after 10 years, when inhaled and sc insulin were available vs. sc insulin alone, were 14.7% vs. 16.1% for myocardial infarction and stroke, 5.2% vs. 5.9% for proliferative retinopathy, 43.4% vs. 47.3% for microalbuminuria and 14.1% vs. 17.2% for clinical neuropathy. In sensitivity analyses, EXU's advantages remained when insulin uptake was capped at 60% (i.e. always at least 40% on OADs). CONCLUSION: Delaying insulin initiation increases the rate of complications. The results showed that when insulin use is increased due to the availability of inhaled insulin, a reduction in all-cause mortality and the number of complications should be observed. Exubera has the potential to improve diabetes management by overcoming barriers to insulin initiation in T2DM patients, and could help prevent more long-term complications associated with T2DM.