gentlemen. This morning I along with the FDA statistician will be presenting the results
of the MACE analyses performed. To give you an overview of what I will be discussing,
I will briefly introduce Saxagliptin outlined as clinical development program and detail
the common phase 2I study design. I will then go into subject demographics and
disposition and subject exposure. I will then present the core of this talk the MACE
analysis, which will include a presentation by the FDA statistician and a brief summary
will conclude the presentation. As much of this information in the next few slides is
already been presented this morning, I will be brief.
NAOMI LOWY, M.D.
Squibb is seeking an indication for Saxagliptin as an adjunct to diet and exercise to
improve glycemic control in patients with type 2 Diabetes Mellitus. DPP-4 is the enzyme
responsible for inactivation of GLP-1 and GIP, the incretin hormones, and in response to
an enteral glucose challenge, the ingredients are gut hormones that regulate postprandial
glucose excursion in a glucose dependent manner. Incretins regulate postprandial
glucose excursion both by increasing Insulin secretion and decreasing glucagon release.
This effect is glucose dependent, hypoglycemia is minimized. Januvia is currently the
only FDA approved DPP-4 inhibitor.
Good morning, Mr. Chairman, members of the Committee, Ladies and
Saxagliptin is an oral Dipeptidyl peptidase-4 inhibitor and Bristol-Myers
meeting is open for public observation, public attendees may not participate except
with the specific request of the panel. Dr. Lowy is presenting.
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The phase 2b3 program included in the NDA is comprised of eight
studies. Six are phase 2I studies in which the main study period was 24 weeks, a phase-