X hits on this document

553 views

0 shares

0 downloads

0 comments

34 / 170

13

Saxagliptin in a wide range of patients. We designed our phase 3 program in consultation

14

with the FDA. The program was designed to support an indication to improve glycemic

15

control in adults with type 2 diabetes. The pivotal phase 3 studies inform the use of

16

Saxagliptin as monotherapy, add-on combination therapy, and initial combination

17

therapy.

2

development programs. The non-clinical development program included in vitro and in

3

vivo assessments of the pharmacodynamic, safety pharmacology and pharmacokinetic

4

properties of Saxagliptin. We conducted multiple experimental studies of the metabolism

5

of Saxagliptin and characterized the toxicology and toxicokinetics of Saxagliptin in

6

multiple species.

23

comprehensive and extensive. We studied over 5,300 subjects, of which more than 4,600

24

received Saxagliptin. A distinguishing feature of the clinical program was the evaluation

Scribes, LLC Toll Free 1-800-675-8846 www.scribesllc.com

8

the safety, pharmacokinetics, and mechanism of action. We characterized the potential of

9

drug-drug interactions, and studied Saxagliptin on multiple special populations. We

10

initially characterized the safety and efficacy of Saxagliptin across a wide range of doses

11

in a phase 2/b dose ranging study.

20

CLINICAL EFFICACY AND CLINICAL SAFETY

1

I will now provide a brief summary of our non-clinical and clinical

33

7

We conducted an extensive clinical pharmacology program to characterize

12

Our phase 3 registrational program informs the safety and efficacy of

18

19

Dr. Roland Chen will now provide a summary of the clinical profile of

Saxagliptin. Dr. Chen.

21

22

ROLAND CHEN, M.D.

Thank you, Bob. The Saxagliptin Clinical Development Program was

Document info
Document views553
Page views553
Page last viewedSun Dec 11 04:36:14 UTC 2016
Pages170
Paragraphs7975
Words54271

Comments