11

The incidence rate ratio for primary MACE for the phase 2b/phase 3 pool population is

12

shown at the top of the slide. The incidence rate ratio for each individual study is shown

13

below. The point estimate and the 95% of confidence intervals are shown relative to a

14

vertical line drawn at unity. Data to the left of the vertical line indicate the Saxagliptin is

15

better, data to the right of the vertical line indicate the control is better.

5

weighted Kaplan Meier estimate for cumulative proportion. The X-axis represents time

6

measured in weeks, the Y-axis represents the cumulative percent of patients with primary

7

MACE. The data in this figure do not indicate increased risk for primary MACE for

8

Saxagliptin treatment patients during either the short-term or the long-term phase of our

9

studies.

17

the incidence rate ratio was 0.83. As expected, there was some variability in the point

18

estimate for each individual trial, but there was considerable overlap in the confidence

19

intervals indicating consistency in results for the trials in the phase 2b/phase 3 program.

20

Our statistical analysis plan specified that we would analyze primary MACE in sub

21

groups of patients with clinical evidence of cardiovascular disease and with

22

cardiovascular risk factors.

10

The next slide summarizes the incidence rate ratio for primary MACE.

52

16

In the pooled analysis the upper bound or the 95% confidence interval for

1

on the results of a primary MACE. However, as stated previously, the results for the

2

FDA defined endpoint of custom MACE would be nearly identical to the results for

3

primary MACE.

23

Our analysis plan specified sub groups of patients who are believed to be

24

at increased risk of CV events based on epidemiologic data. Those sub groups included

4

This slide depicts the time to onset of first primary MACE using a

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