| Outcome Measures: |
Primary: Dose-corrected area-under-the serum insulin concentration vs. time curve (AUC0-540 min) for inhaled Technosphere® Insulin compared to that of subcutaneous regular human insulin, crossover approx every 2 weeks for up to 10 weeks|Area under the glucose infusion rate (GIR AUC0-540 min) for Technosphere® Insulin compared to regular human insulin, crossover approx every 2 weeks for up to 10 weeks|Intra-patient and inter-patient comparison of CV % between treatments was based on a t-test.for bioavailability (ie, SI AUC0-540 min) & bioeffect (ie, GIR AUC0-540 min), crossover approx every 2 weeks for up to 10 weeks | Secondary: Safety variables included adverse events, HbA1c, pulmonary function tests, and diabetes-specific signs (ie, hypoglycemia and hyperglycemia), crossover approx every 2 weeks for up to 10 weeks|Safety variables included adverse events (AEs), clinical laboratory tests, HbA1c, pulmonary function tests, electrocardiograms, vital signs, physical examinations, and diabetes-specific signs, crossover approx every 2 weeks for up to 10 weeks
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