effects improved beta cell function and alpha cell function are complementary to the
mechanism of action for existing therapies, making Saxagliptin a good option as either
monotherapy or as combination therapy. Saxagliptin has been studied on a large clinical
development program at exposures up to 80x the proposed usual clinical dose, 5 mgs
2 diabetes, particularly for new therapies that address some of the tolerability and safety
issues associated with currently available agents. Saxagliptin provides clinically
meaningful improvements in glycemic control as shown by consistent effects to reduce
hemoglobin A1c, fasting plasma glucose and postprandial glucose. The glycemic benefit
of Saxagliptin has been demonstrated when given as monotherapy, add-on combination
therapy, and initial combination therapy.
experience at twice the proposed usual clinical dose. It has a low risk for hypoglycemia,
has no or minimal differences in body weight change compared to control, and has no
identified clinical signal for hepatic, pancreatic or renal safety concerns. There is no
human clinical correlate to skin findings seen in monkeys. There was a small decrease in
mean lymphocyte count that was not progressive and not associated with infectious
related adverse outcomes.
This benefit is consistently seen across sub groups of patients. Saxagliptin
It was well tolerated at all doses studied in phase 3, including a substantial
therapies for type 2 diabetes, we performed numerous meta-analyses of the long-term
experience of Saxagliptin and eight randomized controlled phase 2b/phase 3 studies.
These meta-analyses included data from over 3,300 patients exposed to Saxagliptin for
In summary, there is substantial unmet need for new treatments of type
Given concerns regarding the cardiovascular safety profile of new
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