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DR. WOLF: It would be hard to make that statement relative to an active

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controlled trial. Our statements at the present time are based upon comparison to placebo

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Saxagliptin, it does not demonstrate any worrisome trends for hypoglycemia in primarily

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placebo-controlled trials. The proper way to assess that is do active control studies. We

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currently have an active control study ongoing, a head-to-head study against Sulfonylurea

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on top of Metformin and this study is long in duration and is ongoing at this time. So,

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one of the reasons that we are conducting the study is to address that very question.

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definition of primary MACE, and I just wonder if you could share with us how you came

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to it, I guess if I were thinking about it for the first time, I might think along - what I

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think was along the lines of thinking that the FDA followed that, let's start with SMQMI

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and go from there. You didn't do that and I just wonder if you could tell us how you got

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to that primary definition and is it really the first one you tried or, what can you tell us

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about that?

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because I didn't really see evidence in the data set to support a claim I guess, that you

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have less propensity to hypoglycemia than other agents, in the signals that you presented,

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there was nothing worrisome about an excess amount of hypoglycemia, but nor was - did

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I see any support that you would be relatively less prone to hypoglycemia than other

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agents. Is that something you think you can defend based on the clinical data?

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DR. KONSTAM: All right. So at this point, it's really hard to make that

statement definitively I guess.

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primarily.

DR. KONSTAM: Okay. The second question I have is about your

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DR. WOLF: We agree with your assessment of the current data for

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