Saxagliptin in a wide range of patients. We designed our phase 3 program in consultation
with the FDA. The program was designed to support an indication to improve glycemic
control in adults with type 2 diabetes. The pivotal phase 3 studies inform the use of
Saxagliptin as monotherapy, add-on combination therapy, and initial combination
development programs. The non-clinical development program included in vitro and in
vivo assessments of the pharmacodynamic, safety pharmacology and pharmacokinetic
properties of Saxagliptin. We conducted multiple experimental studies of the metabolism
of Saxagliptin and characterized the toxicology and toxicokinetics of Saxagliptin in
comprehensive and extensive. We studied over 5,300 subjects, of which more than 4,600
received Saxagliptin. A distinguishing feature of the clinical program was the evaluation
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the safety, pharmacokinetics, and mechanism of action. We characterized the potential of
drug-drug interactions, and studied Saxagliptin on multiple special populations. We
initially characterized the safety and efficacy of Saxagliptin across a wide range of doses
in a phase 2/b dose ranging study.
CLINICAL EFFICACY AND CLINICAL SAFETY
I will now provide a brief summary of our non-clinical and clinical
We conducted an extensive clinical pharmacology program to characterize
Our phase 3 registrational program informs the safety and efficacy of
Dr. Roland Chen will now provide a summary of the clinical profile of
Saxagliptin. Dr. Chen.
ROLAND CHEN, M.D.
Thank you, Bob. The Saxagliptin Clinical Development Program was