DR. CHEN: Could I have slide 2-101 please. This slide summarizes the
baseline creatinine clearance at baseline for our phase 2/phase 3 pool population. Data
are shown for the various Saxagliptin doses, all Saxagliptin in control. We have broken
this out into creatinine clearance of less than 50. We have cut the 50-80 range into two
categories - that is 50-65 milliliters per minute, 65-80, and greater than 80. As Dr. Wolf
have long-term duration experience in our clinical program. If I could have the slide that
shows the experience, please project slide 3-51. This slide summarizes the experience in
our phase 2b/phase 3 program for patients who had at least five years’ or ten years’
duration of type 2 diabetes. Please note that approximately 20-30% and in some cases
40% of patients had at least five years of disease. You see the experience for at least ten
years. This slide also displays the experience for creatinine clearance below 80. I know
that you asked for greater detail and that’s what we are going to provide to you now. Dr.
50. This distribution was largely a consequence of our broad use of Metformin in our
clinical program and the Metformin package label, which actually contra-indicates
patients who have serum creatinines of greater than 1.5 or 1.4, depending on gender. As
Dr. Wolf mentioned earlier we are conducting a renal study in patients with moderate,
severe, or end-stage renal disease to gain more experience in this patient population.
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at the experience with skin cancers in the clinic and again we saw no evidence for a
signal for increase in skin cancers among Saxagliptin-exposed patients.
mentioned earlier, the majority of patients had a creatinine clearance that was greater than
80 at baseline. About 16% of those patients had creatinine clearances between 50 and 80.
There was a comment during the morning proceedings about whether we
About 1 to 1.5%, a small minority, had creatinine clearances of less than