monotherapy study 11. At week 24, approximately 70% of subjects in the Saxagliptin
treatment groups remained while this was approximately 58% for placebo subjects.
Within the Saxagliptin groups, no dose response was seen. These are graphs for the three
add-on combination studies. In the add-on to Metformin study, approximately 75% of
subjects were retained in the short-term period by week 24 while only 63% of placebo
subjects remained. In the add-on to Glyburide study, 77% of the Saxagliptin treated
subjects remained at the end of the short-term period, while this was 66% for placebo.
Interestingly, for the add-on to TCD studies the numbers were similar for Saxagliptin
treated and placebo subjects, both around 80%.
randomized treatment with open label rescue, and this clearly has important
implications versus an overt open label extension. As representatives for the core phase
2I studies, I will show the disposition data for one monotherapy study as well as the add-
on combination studies.
ranged from 78 to 90%. While I will not go into detail about disposition into the long-
term periods since they are still ongoing, I will mention that as of the 120-day safety
update, 50 to 58% of subjects in the monotherapy studies remained in the long-term
period, 29 to 77% remained in the add-on combination studies and 66 to 77% of subjects
remained in the long-term period of the initial combination with Metformin study.
Here is a graphical representation of the short-term disposition data for
The proportion of randomized subjects who entered the long-term period
Saxagliptin. As was with the demographic data, the exposure data is of particular
relevance when interpreting Forest plots to be shown later in the statistical presentation.
The analyses performed by FDA in the applicant were based on exposures from the short-
Next I will present exposure data for subjects who were treated with
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