MACE analysis. These lines represent the median exposure and these represent the full
range of exposure. We can see that monotherapy study 11 and that the add-on to
Metformin study 14 have the greatest exposures, both around 90 and 100 weeks. While
studies eight and 41, the phase 2b and the phase 3 mechanism of action studies have the
lowest exposures. The remaining studies had fairly consistent exposures.
published in February of 2008 recommends that phase 2I trial data for drugs developed
for type 2 two diabetes be available for at least 2500 subjects exposed to the
investigational product with at least 1300 to 1500 of these subjects exposed for one year
or more and at least 300 to 500 exposed to the product for 18 months or more. I show
you this slide to confirm that the Sponsor met these recommendations.
The database for the requested MACE analyses consists of the eight phase 2b3 studies
already mentioned. Seven of the eight are placebo controlled. The initial combination
with Metformin study contained active and placebo comparisons. The analyses requested
by FDA were performed on the following. The short-term 24-week period alone which
excludes data collected after glycemic rescue, and then the short-term plus long-term
data, which does include data following the initiation of rescue therapy. Again subjects
who continued into the long-term period remained on double-blind randomized
These are box plots that show exposure for each of the studies used in the
I will now delve into the core of the presentation of the MACE analyses.
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term and long-term periods. Therefore this includes rescued subjects and data from the
120-day safety update. This slide summarizes the exposure in Saxagliptin treated
To put this into context for you, the FDA Draft Guidance for diabetes