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patients with type 2 diabetes to reach glycemic targets. We conducted a study that

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assessed the safety and efficacy of Saxagliptin plus Metformin given as initial therapy

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versus Saxagliptin or Metformin monotherapy in treatment naive patients with higher

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A1c values at baseline. That is, a patient population less likely to reach goal on

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monotherapy alone.

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blinded fashion to 15 mgs in the short-term period. Approximately 92% of patients in

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this group received 15 mgs at the end of the study period. This was thus a study of

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Saxagliptin added on to a mid-dose SU versus continued up titration of the mid-dose

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monotherapy SU. There was little effect observed in the up titrated glyburide arm as

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compared to decreases in A1c of 0.54% and 0.64% in the Saxagliptin 2.5 mgs and 5 mgs

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arms. These changes were both statistically significant versus control. Of note, in all

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three studies the 5 mgs group led to the greatest numerical decrease in A1c.

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groups; Metformin monotherapy, Saxagliptin monotherapy at 10 mgs once daily,

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Saxagliptin 5 mgs once daily plus Metformin, and Saxagliptin 10 mgs once daily plus

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Metformin. In the three treatment groups that contain Metformin, Metformin could be

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titrated to achieve a maximal total daily dose of 2,000 mgs. Saxagliptin 5 or 10 mgs

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given as initial combination treatment led to similar decreases in A1c of 2.5%. These

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changes were statistically significant compared with both monotherapy components

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alone. In the studies just presented as described in our briefing book, the proportion of

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Initial anti hyperglycemic monotherapy is frequently insufficient to enable

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In this study eligible patients were randomized to one of four treatment

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four-week placebo lead-in period. The patients were then randomized to Saxagliptin

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2.5 or 5 mgs added on to 7.5 mgs glyburide versus 10 mgs of glyburide.

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In the glyburide monotherapy arm, titration of glyburide was permitted in

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