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received Saxagliptin 5 mgs added to an intermediate dose of SU compared with up

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titration of SU monotherapy. The difference, 14.6% compared with 10.1%, was not

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statistically significant. Events of confirmed hypoglycemia, defined as symptoms of

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hypoglycemia and with fingerstick blood glucose measurement less than or equal to 50

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mg/dL, were infrequent and also occurred at similar rates for Saxagliptin 5 mgs and

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placebo under all treatment conditions.

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secretion in a glucose dependent manner thereby minimizing the risk of hypoglycemia.

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This table summarizes both reported and confirmed events of hypoglycemia for

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Saxagliptin in the phase 3 studies and for the placebo controlled pool population. In

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accordance with its mechanism of action, the frequency of reported hypoglycemia, that is

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symptoms of hypoglycemia, in patients who received Saxagliptin 5mgs as monotherapy

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or in combination with Metformin or TZD was similar to those reported in patients who

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received placebo.

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(erosions and ulcers), in cynomolgus monkeys exposed to Saxagliptin. As a

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consequence, we closely monitored skin related adverse events in the phase 3 program,

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including measures to provide investigator training and supplemental data collection

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DPP-4 inhibitors augment the action of GLP-1, increasing Insulin

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The incidence of hypoglycemia was numerically higher for patients who

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of reported hypoglycemia in patients who receive Saxagliptin in combination with

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Metformin, whereas monotherapy at 10 mgs range from 1.5% to 5%, compared with 4%

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in those patients who received Metformin monotherapy.

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Similarly, in our initial combination study with Metformin, the incidence

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In non-clinical studies, we observe multi-focal reversible skin lesions

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