Diabetes Mellitus, Type 2 Clinical Trial
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.
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.
After review of the meal challenge data from the Original Protocol design, it became
apparent that the TI Inhalation Powder, insulin lispro, and Exubera doses were not well
matched, and resulted in significantly higher insulin exposure following insulin lispro than
the two inhaled treatments. All meal challenge visits were completed for the 18 subjects
enrolled. However, the glucose clamp visits were discontinued since it was discovered that a
direct comparison between the treatments was not possible.
The protocol was amended (Amendment 1) to ensure that the insulin exposures between TI
Inhalation Powder and insulin lispro were more suited (increased the TI Inhalation Powder
doses and decreased the insulin lispro dose). An Exubera arm was not included in Amendment 1
due to the market removal of this product.
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.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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