this period, supporting a beneficial effect at the level of the alpha cell. In addition to
decreasing plasma glucose following oral glucose challenge, treatment with Saxagliptin
led to statistically significant reductions in fasting plasma glucose versus control in all
phase 3 studies. In the six pivotal studies, Saxagliptin 5 mgs led to decreases in fasting
plasma glucose ranging from 10mgs to 23 mg/dL relative to control. In these studies,
differences in fasting plasma glucose between Saxagliptin and control were seen as early
as week two, the earliest time point of measurement. The impact of Saxagliptin on
fasting plasma glucose provided clinical evidence for improvement in basal beta cell
function as also indicated by corresponding increases in phase 2b.
mgs led to decreases of 31 mgs to 50 mg/dL relative to control in two-hour plasma
glucose. The reductions in postprandial glucose we saw in conjunction with increases in
Insulin provide evidence for the effect of Saxagliptin in improving beta cell function.
antihyperglycemic effects across subgroups of demographic and baseline diabetes
characteristics. This figure summarizes control subtracted A1c lowering from baseline
by gender, race, age, A1c at baseline, duration of diabetes, and creatinine clearance for
Saxagliptin 5 mgs as add-on therapy to Metformin. Consistent and clinically meaningful
reductions in A1c that is between 0.6% and 1% were seen for all sub groups.
In addition, we also observed decreases in postprandial glucagon during
Treatment with Saxagliptin consistently led to beneficial
significant decreases in glucose at 120 minutes as well as three-hour glucose area
under the curve following standard oral glucose challenge versus control.
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As shown in this figure, in the six pivotal phase 3 studies, Saxagliptin 5
In summary, Saxagliptin 5 mgs given as monotherapy, add-on
combination treatment, and initial combination therapy with Metformin led to consistent,