age was low to mid 50s, subjects had diabetes for a mean of two to three years and in
study 11, 2.5% of subjects had prior diabetes treatment while 5% of subjects in study 38
had prior treatment. The history of coronary artery disease reported was approximately
5% in study 11 and was higher at 13% in study 38. This is the demographic data for
subjects in the initial combination with Metformin study with data fairly consistent with
those seen in the monotherapy studies. Again, the mean age was 52 years, subjects had
duration of diabetes of 1.7 years, 8% of subjects had a history of coronary artery disease
and 2% reported previous diabetes treatment.
important when interpreting the Forest plots that will be shown in the statistical
presentation. Because these are the major contributor to the Forest plots, I will be
presenting the study separately as un-pool data. Within each study however, the
treatment groups are pooled since they were well balanced.
I will next present disposition data emphasizing the short-term period here
since the MACE analysis will rely heavily on the short-term periods as well as the short-
Here is the demographic data for the two monotherapy studies. The mean
The main differences from previous slides are the duration of diabetes and previous
diabetes treatment. The duration of diabetes-ranged from five to 6.9 years which we
would expect as these subjects entered the study already on medical therapy. Therefore
100% of these subjects had previous diabetes treatment.
term plus long-term periods. It is important to remember that the short-term safety data
includes subjects who have not been rescued. Across all the core phase 2I studies, 74%
of subjects completed the short-term period. The majority of dropouts were due to
rescue. I would reiterate that these were not typical dropouts since they continued on
Finally, the demographic data for the three add-on combination studies.
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