about the number of patients who had baseline Diabetic Kidney Disease. If I could
please project slide 3-52, so this slide summarizes the prevalence of micro-vascular
complications of type 2 diabetes in our population. I think we may need to comeback to
you after the break on the breakdown by severity of renal impairment. The vast majority
of the patients who had an abnormal creatinine clearance were between 50 and 80. So
they fall into the mild category. I do want to remind the committee that we have an on
going clinical trial, randomized clinical trial examining patients who have both moderate
and severe renal impairment.
DR. WOLF: We did not see evidence for pancreatic injury in our non
clinical safety studies, and I will now ask Dr. Roland Chen to come to the podium to
describe our clinical experience in pancreatitis and the clinical development program.
Two quick questions, number one, do you have any further information on tumors of the
skin either in animals or humans, you talked about ulcerations a little bit, and any more
information on pancreatitis whether it’s acute or chronic or silent with elevation of
pancreatic enzymes either in animal or human?
program were frequent and balanced between the treatment groups. Can I have slide 27-
1 please. This slide summarizes the adverse events of pancreatitis in our phase 2b3 pool
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whether they were based on a hypercholesterolemia or not. Approximately half of the
DR. BURMAN: Thank you. I had a question for the Sponsor as well.
DR. CHEN: Events of pancreatitis seeing in the Saxagliptin clinical
patients we had based on hypercholesterolemia were on a Statin.
DR. TEERLINK: That’s very helpful. My question was in regards to the
stages of chronic kidney disease that patients had in enrollment before at baseline.
DR. WOLF: Let me first share some data with you, we were asked also