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double-blind treatment, secondary endpoints included change from baseline to week 24 in

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fasting plasma glucose, proportionate patients achieving a therapeutic glycemic response

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to find his A1c of less than 7% at week 24, and change from baseline to week 24 in the

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area under the curve from zero to 180 minutes for postprandial glucose response to a

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standard oral glucose challenge. All efficacy endpoints were evaluated prior to the

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initiation of rescue therapy.

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parallel arm and multi-center in design. All studies had a placebo lead-in period followed

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by a 24-week double blind short-term period. These studies included controlled

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extensions of 12 to 42 months, allowing long-term comparisons of Saxagliptin relative to

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control therapies. In order to allow patients with worsening glycemic control to remain

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safely in the studies, there was provision for rescue medication based on pre-specified

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glycemic criteria. These studies shared a common primary endpoint and a number of key

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secondary endpoints.

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in treatment-naive patients with A1c values ranging from 7% to 10% at baseline. The

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first study randomized approximately 400 patients to Saxagliptin given at fixed doses of

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2.5 mgs, 5mgs, or 10 mgs versus placebo. In this study Saxagliptin led to decreases of

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0.43%, 0.46% and 0.54% from baseline. The decreases in A1c were statistically

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significant versus placebo for all three treatment groups.

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The primary endpoint was change in A1c from baseline to week 24 of

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Two of our six phase 3 studies examine Saxagliptin given as monotherapy

Scribes, LLC Toll Free 1-800-675-8846 www.scribesllc.com

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transplant or diagnosed with HIV, or demonstrated abnormalities on screening tests

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with hepatic, renal or hematologic function.

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The six pivotal phase 3 studies were randomized, double blind, control

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