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MACE analysis. These lines represent the median exposure and these represent the full

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range of exposure. We can see that monotherapy study 11 and that the add-on to

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Metformin study 14 have the greatest exposures, both around 90 and 100 weeks. While

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studies eight and 41, the phase 2b and the phase 3 mechanism of action studies have the

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lowest exposures. The remaining studies had fairly consistent exposures.

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published in February of 2008 recommends that phase 2I trial data for drugs developed

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for type 2 two diabetes be available for at least 2500 subjects exposed to the

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investigational product with at least 1300 to 1500 of these subjects exposed for one year

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or more and at least 300 to 500 exposed to the product for 18 months or more. I show

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you this slide to confirm that the Sponsor met these recommendations.

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The database for the requested MACE analyses consists of the eight phase 2b3 studies

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already mentioned. Seven of the eight are placebo controlled. The initial combination

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with Metformin study contained active and placebo comparisons. The analyses requested

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by FDA were performed on the following. The short-term 24-week period alone which

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excludes data collected after glycemic rescue, and then the short-term plus long-term

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data, which does include data following the initiation of rescue therapy. Again subjects

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who continued into the long-term period remained on double-blind randomized

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treatment.

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These are box plots that show exposure for each of the studies used in the

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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

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120-day safety update. This slide summarizes the exposure in Saxagliptin treated

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subjects.

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To put this into context for you, the FDA Draft Guidance for diabetes

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