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In all four treatment paradigms the 5 mgs group provided greater efficacy

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than the 2.5 mg group. The difference in A1c lowering was 0.1% to 0.3% greater for the

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5 mg versus 2.5 mg group. The aggregate data support the 5 mg dose as the usual clinical

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dose. Overall, in all treatment paradigms that is, Saxagliptin given as monotherapy or as

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add-on treatment to Metformin, TZD, or SU, A consistent efficacy benefit was observed

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for Saxagliptin 5 mgs versus 2.5 mgs. These results are consistent with observations of

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ability to further understand the dose response for efficacy. This figure summarizes A1c

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lowering for the 2.5 mg and 5 mg groups over four treatment paradigms, that is, as

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monotherapy, add-on treatment to Metformin, add-on to TZD, and add-on to SU, based

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on findings from the six phase 2b/3 studies that contain this dose. In order to further

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understand the effects of Saxagliptin as monotherapy, we performed post-hoc pooled

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analysis of the three phase 2b/3 monotherapy studies for A1c lowering at week 12. The

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monotherapy studies were the smallest in our clinical program. This analysis enabled us

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to incorporate the entirety of our monotherapy experience at a common time point.

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10 mgs versus 5 mgs. As we will show later, the safety profile with the 2.5 mg and 5 mg

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groups were generally comparable. As a consequence, 5 mgs is our proposed usual

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clinical dose. The preceding analyses have focused on changes from baseline in A1c, the

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5 mg dose also proved to be effective when we assessed its impact on postprandial

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glucose and fasting plasma glucose. We observed clinically meaningful and statistically

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patients who achieve the pre specified glycemic goal of A1c less than 7% was also

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larger in the Saxagliptin treatment groups compared with the control groups.

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greater DPP-4 inhibition at trough with the 5 mg versus 2.5 mg dose.

In contrast, there was no evidence for an incremental efficacy benefit for

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The study of multiple doses in the phase 2b/3 program enhanced our

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