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combination treatment to achieve adequate glycemic control. As such, we performed

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three studies of Saxagliptin given as add-on therapy to patients inadequately controlled

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on three commonly used classes of medication. In the first study, 743 patients

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inadequately controlled on 1,500 mgs or greater of Metformin were randomized to

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Saxagliptin 2.5 mgs, 5 mgs, or 10 mgs versus placebo in addition to their previous

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Metformin dose. In this study Saxagliptin led to decreases in A1c of 0.59%, 0.69% and

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0.58% from baseline, decreases that were all statistically significant versus placebo.

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to one of five treatment arms, Saxagliptin 2.5 mgs or 5 mgs given once in the morning,

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Saxagliptin 2.5 mgs with provision for titration to 5 mgs based on pre-specified glycemic

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criteria, Saxagliptin 5 mgs given in the evening, or placebo. In this study Saxagliptin led

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the decreases in A1c from baseline ranging from 0.61% to 0.71% as was the case for the

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first monotherapy study the decreases in A1c were statistically significant versus placebo

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for all treatment groups.

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from baseline. These changes were also statistically significant compared to placebo. In

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the third study a total of 768 patients inadequately controlled on a sub maximal dose of

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Sulfonylurea were all placed on a standard dose of 7.5 mgs glyburide upon entering a

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The second study, which was smaller in size, randomized 365 patients

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Type 2 diabetes is a progressive disease and many patients require

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or 45 mgs of pioglitazone or 4 mgs or 8 mgs total daily dose of rosiglitazone were

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randomized to Saxagliptin 2.5 mgs or 5 mgs versus placebo, in addition to their TZD

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regimen upon study entry.

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In the second study, 565 patients inadequately controlled on either 30 mgs

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In this study, Saxagliptin led to reductions in A1c of 0.66% and 0.94%

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