423 patients. This was a randomized controlled study that included five Saxagliptin
doses of 2.5 mgs, 5 mgs, 10 mgs, 20 mgs and 40 mgs compared with placebo given for
12 weeks. The study demonstrated greater lowering of A1c and fasting glucose at the 5
mg dose compared with the 2.5 mgs dose without evidence for incremental benefit at
higher doses. There was no dose limiting toxicity observed in this study. As a
consequence, doses of 2.5 mgs, 5 mgs and 10 mgs once daily were chosen for further
study in the phase 3 program. 5 mgs were included in all studies in the phase 3 program.
2.5 mgs enabled further study at the lower end of the dose range, and 10 mgs provided
additional safety experience at the high end of the dose range and addressed whether
greater efficacy would be evident with longer exposure beyond 12 weeks.
These studies included over 4,600 patients of which more than 3,400 received
Saxagliptin. The program included a phase 2b monotherapy dose ranging study, six
pivotal phase 3 studies and a phase 3 mechanism of action study. The six pivotal studies
evaluated Saxagliptin over a range of different treatment modalities including
administration as monotherapy, add-on combination treatment, and as initial combination
therapy with Metformin.
control across a range of A1c values by study. Age of the entry was 18 to 77 years.
Patients were excluded who had a recent significant cardiovascular event. In addition,
patients were excluded who had history of significant heart failure. Patients were also
excluded if they were immunocompromised. For example, having undergone organ
Saxagliptin was evaluated in a phase 2b dose ranging study that included
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.