FDA guidance on antihyperglyacemic therapies for type 2 diabetes: One decade later

Author:

McGuire Darren K.1ORCID,Marx Nikolaus2,Johansen Odd Erik3ORCID,Inzucchi Silvio E.4,Rosenstock Julio5ORCID,George Jyothis T.6

Affiliation:

1. Division of CardiologyUniversity of Texas Southwestern Medical Center Dallas Texas

2. Department of Internal Medicine IUniversity Hospital Aachen, RWTH Aachen University Aachen Germany

3. Clinical DevelopmentTherapeutic Area Cardiometabolism, Boehringer Ingelheim Asker Norway

4. Section of EndocrinologyYale University School of Medicine New Haven Connecticut

5. Dallas Diabetes Research Center at Medical City and University of Texas, Southwestern Medical Center Dallas Texas

6. Clinical DevelopmentTherapeutic Area Cardiometabolism, Boehringer Ingelheim Ingelheim Germany

Funder

Boehringer Ingelheim

Publisher

Wiley

Subject

Endocrinology,Endocrinology, Diabetes and Metabolism,Internal Medicine

Reference47 articles.

1. US Department of Health and Human Services Food and Drug Administration. Guidance for Industry. Diabetes Mellitus ‐ Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes. 2008. Available atwww.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm071627.pdf(accessed October 8 2018).

2. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes

3. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes

4. Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes

5. Intarcia press‐release Oct 9th 2018.https://www.intarcia.com/media/media‐archive/press‐releases/intarcia‐announces‐successful‐cardiovascular‐safety‐results‐in‐p.html. Accessed Oct 9 2018.

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