DR. TEERLINK: Okay, and related to that, what would be very useful is
obviously one of the things that's in the recommendations from the diabetes guidelines is
that it says specifically that program should include patients at high risk of cardiovascular
recent cardiovascular event from our clinical trial experience. We did look carefully at
the incidents of cardiovascular events in subsets of patients who were at increased risk;
even in those subsets of patients we did not see a signal for cardiovascular harm for
of patients were above 65 years of age, and the majority of patients had duration of
diabetes much less than five years. I would appreciate if you could preset more detail on
the breakdown of the renal insufficiency experience where a breakdown of 80 millimeters
per minute is not all that informative as well as a breakdown of the details that micro-
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intent of your inclusion and exclusion criteria in the data set that we have before us,
that's the first question.
approval we would - and we are planning a comprehensive set of studies including,
pharmacoepidemiologic studies and additional randomized clinical trial studies as Dr.
Daniels described in higher risk patients.
events such as, patients with relatively advanced disease, elderly patients and patients
with some lesser degree of - some degree of renal impairment, granted that it's for new
clinical programs and so you don't technically fall under that requirement although, I
guess that's part of what this committee meeting is about.
DR. WOLF: I agree with you that we did exclude patients who had had a
Nonetheless, it's still probably useful to see. I saw that you had only 15%
DR. TEERLINK: Based on 40 events?
DR. WOLF: Based on 40 events. As part of our plan going forward post