A Study Comparing Subcutaneous Rapid Acting Insulin and One Formulation of Inhaled Insulin in Subjects With Type 2 Diabetes
Status:
Completed
Trial end date:
2009-01-01
Target enrollment:
Participant gender:
Summary
The original protocol was a randomized, open-label, 3-way cross-over study with 9 scheduled
visits. The visits comprised an initial screening visit, 3 treatment visits for the meal
challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 3
sequential visits for the glucose clamp, and a final close-out visit.
Protocol Amendment 1 was a randomized, open-label, 2-way cross-over study with 7 visits for
each completed subject. The visits comprise an initial screening visit, 2 treatment visits
for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety
visit, 2 sequential visits for the glucose clamp, and a final close-out visit.
For both the original protocol and Protocol Amendment 1, subjects were hospitalized in the
clinical unit for all procedures.