received Saxagliptin 5 mgs added to an intermediate dose of SU compared with up
titration of SU monotherapy. The difference, 14.6% compared with 10.1%, was not
statistically significant. Events of confirmed hypoglycemia, defined as symptoms of
hypoglycemia and with fingerstick blood glucose measurement less than or equal to 50
mg/dL, were infrequent and also occurred at similar rates for Saxagliptin 5 mgs and
placebo under all treatment conditions.
secretion in a glucose dependent manner thereby minimizing the risk of hypoglycemia.
This table summarizes both reported and confirmed events of hypoglycemia for
Saxagliptin in the phase 3 studies and for the placebo controlled pool population. In
accordance with its mechanism of action, the frequency of reported hypoglycemia, that is
symptoms of hypoglycemia, in patients who received Saxagliptin 5mgs as monotherapy
or in combination with Metformin or TZD was similar to those reported in patients who
(erosions and ulcers), in cynomolgus monkeys exposed to Saxagliptin. As a
consequence, we closely monitored skin related adverse events in the phase 3 program,
including measures to provide investigator training and supplemental data collection
DPP-4 inhibitors augment the action of GLP-1, increasing Insulin
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
Metformin, whereas monotherapy at 10 mgs range from 1.5% to 5%, compared with 4%
in those patients who received Metformin monotherapy.
Similarly, in our initial combination study with Metformin, the incidence
In non-clinical studies, we observe multi-focal reversible skin lesions