UNC clinical trials play crucial role in FDA approval for diabetes drug

Led by John Buse, MD, PhD, director of the UNC Diabetes Care Center, the clinical research of UNC doctors and the participation of thousands of patients culminates in a new, effective, and safe daily injectable drug to combat type-2 diabetes.

UNC clinical trials play crucial role in FDA approval for diabetes drug click to enlarge John Buse, MD, PhD

Media contact: Mark Derewicz, 984.974-1915, mark.derewicz@unch.unc.edu

November 29, 2016

CHAPEL HILL, NC – This week, the U.S. Food and Drug Administration (FDA) approved Xultophy 100/3.6 – the brand name for combined insulin degludec and the drug liraglutide. It is a daily injection manufactured by Novo Nordisk and generally referred to as IDegLira. John Buse, MD, PhD, Verne S. Caviness Distinguished Professor of Medicine at the UNC School of Medicine and director of the UNC Diabetes Care Center, led the clinical trials at UNC to show that IDegLira was safe and effective for treating patients with type-2 diabetes.

“This approval for Xultrophy is really the culmination of 17 years of clinical trials, for which UNC doctors and researchers provided substantial leadership,” said Buse, who also heads the NC TraCS Institute, the academic home of the NIH Clinical and Translational Science Awards (CTSA) Program at UNC. “From the first patient we studied back in 1999, I was blown away by the efficacy of the combined approach to control glucose and reduce A1C – a three-month average measure of blood sugar. The IDegLIra clinical trials were among the most gratifying that I have participated in.”

At UNC, Buse led the DUAL trials, which demonstrated IDegLira’s impressive A1C reduction with lower rates of hypoglycemia than insulin alone. Also, IDeglira was shown to be significantly better at helping patients control weight and nausea. In the LEADER trial, Buse and others showed that IDegLira controlled blood sugar very effectively while demonstrating across-the-board cardiovascular benefit – the first type-2 diabetes drug to do so.

“In my opinion, I think that IDegLira is the most effective anti-hyperglycemic agent for the vast majority of people with type-2 diabetes inadequately controlled on other treatments,” Buse said. “One could argue that with the availability of IDegLira there’s no clinical rationale for using any of the basal insulin products as the first injected blood glucose lowering drug. Our studies raise the question of whether we should use basal insulin alone at all in the future.”

Xultophy 100/3.6 is administered as a once-daily injection from a prefilled pen and can be taken with or without food. 

The drug company Sanofi also received approval this week for a similar drug, the clinical trials for which Buse was not involved.

 “Our team at UNC played a major role in testing the safety and efficacy of this drug,” Buse said. “And of course, none of this kind of research would be possible if not for the patients we see every day who volunteer for these studies.”

Along with Buse, UNC doctors and researchers involved in the IDegLira clinical trials included, Sue Kirkman, MD, Jean Dostou, MD, Beth Harris, MD, Laura Young, MD, April Goley, NP, Kate Bergamo, NO, Joe Largay, PA-C , and several study coordinators. 

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