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were incorporated both in the short-term and long-term periods. Therefore subjects could

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be rescued at any point. Here I show that the rescue criteria differed between these two

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periods. Rescue in the short-term period was based on fasting plasma glucose ranging

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from 200 to 240, while rescue in the long-term was based on hemoglobin A1c ranging

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from 7% to 8%. The details of the rescue criteria are contained in your briefing

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document, but I will point out that the cut off values dependent on the study week

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becoming more stringent as the study progressed.

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one add-on to Metformin, one add-on to sulphonylurea and one add-on to

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thiazolidinedione, and finally one initial combination with Metformin study. Both the

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monotherapy studies and the initial combination with Metformin studies enrolled

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treatment naive type 2 diabetics. These phase 2I studies also had a common primary

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efficacy endpoint, which was the change in hemoglobin A1c from baseline to week 24.

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same in the short-term and long-term periods. These included Metformin and

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thioglitazone, both of which were titratable. Now I will present the baseline demographic

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data for subjects in the phase 2b3 program. While your briefing document contains a

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more comprehensive list, here I will summarize age, duration of diabetes, history of

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coronary artery disease and previous diabetes treatment. My intention in presenting these

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is for you to understand the cardiovascular risk of the population studied. This risk is

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I mentioned earlier that rescue criteria for uncontrolled hyperglycemia

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I have listed here the specific rescue medications used, which were the

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continue. The Sponsor chose three doses of Saxagliptin to be used in the phase 2I

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program, 2.5 milligrams, 5 milligrams, which is the proposed marketing dose and 10

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milligrams. These are the actual core phase 2I studies.

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There were two monotherapy studies, three add-on combination studies,

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