Investment Research and Business Due Diligence
Thursday, April 18, 2013
The first outcome study on a DPP-IV inhibitor will report data Mid year 2013
The SAVOR study is a placebo-controlled 16,500 patient trial designed to evaluate
the safety and efficacy of saxagliptin (O
with regard to cardiovascular outcomes in
diabetic patients (A1c 6.5 – 12) either with a previous cardiovascular event or at
high risk for cardiovascular events
. The study is expected to report
top line data
by mid year 2013.
data from the study will be
the implications are likely to be across the DPP-IV class. Currently the DPP-IV take about 12 pe
ent share in the the
duction in CV outcome,
ot only h
enhance its mar
ut also help the DPP-
IV class in further increasing its dominance in t
l oral anti-diabetes market.
The data from t
is also awaited as
would also pro
long term safety of the
, especially with regard to the pancreatitis issue.
event driven trial designed to stop when 1040 primary endpoint events are
collected. The primary efficacy and safety endpoint is the time to the first
occurrence of the composite of CV death, non-fatal MI or non-fatal ischemic stroke.
antidiabetics and/or insulin but excluding incretin based therapy. Subjects not being
treated with anti-diabetic medication at baseline are also being enrolled.
Top-line data expected in mid-2013.
Study lead by the academic research organizations TIMI Study Group and
Hadassah University Medical Center.
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