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423 patients. This was a randomized controlled study that included five Saxagliptin

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doses of 2.5 mgs, 5 mgs, 10 mgs, 20 mgs and 40 mgs compared with placebo given for

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12 weeks. The study demonstrated greater lowering of A1c and fasting glucose at the 5

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mg dose compared with the 2.5 mgs dose without evidence for incremental benefit at

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higher doses. There was no dose limiting toxicity observed in this study. As a

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consequence, doses of 2.5 mgs, 5 mgs and 10 mgs once daily were chosen for further

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study in the phase 3 program. 5 mgs were included in all studies in the phase 3 program.

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2.5 mgs enabled further study at the lower end of the dose range, and 10 mgs provided

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additional safety experience at the high end of the dose range and addressed whether

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greater efficacy would be evident with longer exposure beyond 12 weeks.

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These studies included over 4,600 patients of which more than 3,400 received

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Saxagliptin. The program included a phase 2b monotherapy dose ranging study, six

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pivotal phase 3 studies and a phase 3 mechanism of action study. The six pivotal studies

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evaluated Saxagliptin over a range of different treatment modalities including

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administration as monotherapy, add-on combination treatment, and as initial combination

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therapy with Metformin.

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control across a range of A1c values by study. Age of the entry was 18 to 77 years.

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Patients were excluded who had a recent significant cardiovascular event. In addition,

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patients were excluded who had history of significant heart failure. Patients were also

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excluded if they were immunocompromised. For example, having undergone organ

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Saxagliptin was evaluated in a phase 2b dose ranging study that included

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The pivotal phase 3 studies enroll patients with inadequate glycemic

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The Saxagliptin phase 2b/3 clinical program consisted of eight studies.

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