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monotherapy study 11. At week 24, approximately 70% of subjects in the Saxagliptin

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treatment groups remained while this was approximately 58% for placebo subjects.

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Within the Saxagliptin groups, no dose response was seen. These are graphs for the three

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add-on combination studies. In the add-on to Metformin study, approximately 75% of

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subjects were retained in the short-term period by week 24 while only 63% of placebo

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subjects remained. In the add-on to Glyburide study, 77% of the Saxagliptin treated

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subjects remained at the end of the short-term period, while this was 66% for placebo.

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Interestingly, for the add-on to TCD studies the numbers were similar for Saxagliptin

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treated and placebo subjects, both around 80%.

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randomized treatment with open label rescue, and this clearly has important

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implications versus an overt open label extension. As representatives for the core phase

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2I studies, I will show the disposition data for one monotherapy study as well as the add-

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on combination studies.

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ranged from 78 to 90%. While I will not go into detail about disposition into the long-

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term periods since they are still ongoing, I will mention that as of the 120-day safety

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update, 50 to 58% of subjects in the monotherapy studies remained in the long-term

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period, 29 to 77% remained in the add-on combination studies and 66 to 77% of subjects

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remained in the long-term period of the initial combination with Metformin study.

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Here is a graphical representation of the short-term disposition data for

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The proportion of randomized subjects who entered the long-term period

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Saxagliptin. As was with the demographic data, the exposure data is of particular

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relevance when interpreting Forest plots to be shown later in the statistical presentation.

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The analyses performed by FDA in the applicant were based on exposures from the short-

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Next I will present exposure data for subjects who were treated with

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