combination treatment to achieve adequate glycemic control. As such, we performed
three studies of Saxagliptin given as add-on therapy to patients inadequately controlled
on three commonly used classes of medication. In the first study, 743 patients
inadequately controlled on 1,500 mgs or greater of Metformin were randomized to
Saxagliptin 2.5 mgs, 5 mgs, or 10 mgs versus placebo in addition to their previous
Metformin dose. In this study Saxagliptin led to decreases in A1c of 0.59%, 0.69% and
0.58% from baseline, decreases that were all statistically significant versus placebo.
to one of five treatment arms, Saxagliptin 2.5 mgs or 5 mgs given once in the morning,
Saxagliptin 2.5 mgs with provision for titration to 5 mgs based on pre-specified glycemic
criteria, Saxagliptin 5 mgs given in the evening, or placebo. In this study Saxagliptin led
the decreases in A1c from baseline ranging from 0.61% to 0.71% as was the case for the
first monotherapy study the decreases in A1c were statistically significant versus placebo
for all treatment groups.
from baseline. These changes were also statistically significant compared to placebo. In
the third study a total of 768 patients inadequately controlled on a sub maximal dose of
Sulfonylurea were all placed on a standard dose of 7.5 mgs glyburide upon entering a
The second study, which was smaller in size, randomized 365 patients
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or 45 mgs of pioglitazone or 4 mgs or 8 mgs total daily dose of rosiglitazone were
randomized to Saxagliptin 2.5 mgs or 5 mgs versus placebo, in addition to their TZD
regimen upon study entry.
In the second study, 565 patients inadequately controlled on either 30 mgs
In this study, Saxagliptin led to reductions in A1c of 0.66% and 0.94%