double-blind treatment, secondary endpoints included change from baseline to week 24 in
fasting plasma glucose, proportionate patients achieving a therapeutic glycemic response
to find his A1c of less than 7% at week 24, and change from baseline to week 24 in the
area under the curve from zero to 180 minutes for postprandial glucose response to a
standard oral glucose challenge. All efficacy endpoints were evaluated prior to the
initiation of rescue therapy.
parallel arm and multi-center in design. All studies had a placebo lead-in period followed
by a 24-week double blind short-term period. These studies included controlled
extensions of 12 to 42 months, allowing long-term comparisons of Saxagliptin relative to
control therapies. In order to allow patients with worsening glycemic control to remain
safely in the studies, there was provision for rescue medication based on pre-specified
glycemic criteria. These studies shared a common primary endpoint and a number of key
in treatment-naive patients with A1c values ranging from 7% to 10% at baseline. The
first study randomized approximately 400 patients to Saxagliptin given at fixed doses of
2.5 mgs, 5mgs, or 10 mgs versus placebo. In this study Saxagliptin led to decreases of
0.43%, 0.46% and 0.54% from baseline. The decreases in A1c were statistically
significant versus placebo for all three treatment groups.
The primary endpoint was change in A1c from baseline to week 24 of
Two of our six phase 3 studies examine Saxagliptin given as monotherapy
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transplant or diagnosed with HIV, or demonstrated abnormalities on screening tests
with hepatic, renal or hematologic function.
The six pivotal phase 3 studies were randomized, double blind, control