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clinical development program. Our development program provided clinical experience at

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high multiples of our proposed usual clinical dose of 5 mgs. This included exposures of

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400 mgs. That is 80 x the proposed 5 mg dose, for two weeks, 100 mgs for six weeks, 40

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mgs and 20 mgs for 12 weeks, and 10 mgs for 102 weeks. Three doses of Saxagliptin

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were evaluated in the phase 3 program with approximately one-third of the experience

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accrued at 10 mgs or two times that of the proposed usual clinical dose. Saxagliptin was

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well tolerated at all doses without any dose limiting toxicity. The numbers of patients

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included in the Saxagliptin phase 2b/3 program either met or exceeded guidelines issued

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by both ICH and FDA as shown in this table.

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clinically meaningful, and statistically significant reductions in A1c, fasting plasma

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glucose, and postprandial glucose, together with increases in achievement of treatment

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targets. In addition, Saxagliptin led to beneficial effects across various sub groups of

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demographics and baseline diabetes characteristics.

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drugs intended for the long-term treatment of non-life threatening conditions. In

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February of 2008, the FDA issued a new draft guidance for the development of drugs for

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treatment of type 2 diabetes. In this guidance, the FDA identified target numbers for

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patients exposed to the investigational agent for one year and for 18 months. As shown

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in this table we either met or exceeded both guidances at the time we filed the NDA for

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Saxagliptin. By the time we filed the day 120 update to the FDA we had accrued

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substantial additional long-term experience. By that time more than 2,000 patients were

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exposed for one year, 1,000 for 18 months, and 400 for two years. In addition, we

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Saxagliptin safety profile was studied across a wide range of doses in the

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In 1995, ICH issued guidance on exposure to assess clinical safety for

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