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effects improved beta cell function and alpha cell function are complementary to the

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mechanism of action for existing therapies, making Saxagliptin a good option as either

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monotherapy or as combination therapy. Saxagliptin has been studied on a large clinical

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development program at exposures up to 80x the proposed usual clinical dose, 5 mgs

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once daily.

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2 diabetes, particularly for new therapies that address some of the tolerability and safety

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issues associated with currently available agents. Saxagliptin provides clinically

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meaningful improvements in glycemic control as shown by consistent effects to reduce

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hemoglobin A1c, fasting plasma glucose and postprandial glucose. The glycemic benefit

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of Saxagliptin has been demonstrated when given as monotherapy, add-on combination

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therapy, and initial combination therapy.

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experience at twice the proposed usual clinical dose. It has a low risk for hypoglycemia,

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has no or minimal differences in body weight change compared to control, and has no

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identified clinical signal for hepatic, pancreatic or renal safety concerns. There is no

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human clinical correlate to skin findings seen in monkeys. There was a small decrease in

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mean lymphocyte count that was not progressive and not associated with infectious

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related adverse outcomes.

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This benefit is consistently seen across sub groups of patients. Saxagliptin

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It was well tolerated at all doses studied in phase 3, including a substantial

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therapies for type 2 diabetes, we performed numerous meta-analyses of the long-term

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experience of Saxagliptin and eight randomized controlled phase 2b/phase 3 studies.

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These meta-analyses included data from over 3,300 patients exposed to Saxagliptin for

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In summary, there is substantial unmet need for new treatments of type

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Given concerns regarding the cardiovascular safety profile of new

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