Assessing the impact of a new delivery method of insulin on glycemic control using a novel trial design.

Objective: The purpose of the trial was to examine the impact of inhaled human insulin (INH) on patient or physician willingness to adopt insulin after oral diabetes agent failure.

Research Design And Methods: The EXPERIENCE trial was a one-year randomized controlled trial conducted at primary, secondary and tertiary care facilities in Europe and North America. The primary study endpoint was difference in glycated hemoglobin (A(1c)) between randomized groups at 26 weeks, and results from that phase have been reported previously.