Pioneering research by Paresh Dandona, MD, PhD, was cited by the European Commission in its decision to approve dapagliflozin for patients with Type 1 diabetes.
Dandona Research Influences European OK of Diabetes Drug
Published April 24, 2019 This content is archived.
story based on news release by ellen goldbaum
Pioneering research conducted and advanced by Paresh Dandona, MD, PhD, SUNY Distinguished Professor of medicine and chief of endocrinology, diabetes and metabolism, played a key role in the European Commission’s decision to approve dapagliflozin for patients with Type 1 diabetes.
In its announcement in March approving the Type 2 diabetes drug dapagliflozin for adults with Type 1 diabetes when insulin doesn’t provide adequate blood sugar control, the European Commission cited DEPICT-1 and DEPICT-2, randomized clinical trials that demonstrated how it benefits patients with Type 1 diabetes.
Pioneering Study’s Results Published in 2017
Dandona led DEPICT-1 and was the study’s principal investigator and lead author on the paper reporting the trial’s results in The Lancet Diabetes & Endocrinology in September 2017.
“Our pioneering work has led to the licensing of dapagliflozin for Type 1 diabetes in Europe,” Dandona says. “This is a novel oral treatment for Type 1 diabetes, which, when used as an adjunct to insulin, improves the predictability of blood sugar control and provides a real quality of life benefit for patients with the disease.”
Dapagliflozin is marketed under the brand name Forxiga in Europe and Farxiga in the U.S.; it is currently under regulatory review in the U.S. and Japan as an adjunct treatment to insulin for patients with Type 1 diabetes.
Type 1 Diabetes Focus Dates Back to Fellowship
For decades, Dandona has been motivated to find new treatments for Type 1 diabetes, which is still addressed with multiple daily infusions of insulin, which, he likes to point out, was discovered nearly a century ago.
He has led the field in exploring potential treatments to use as adjunct therapies with insulin since his published work on another Type 2 diabetes drug, liraglutide, in 2011.
“The sad state of Type 1 diabetics has haunted me since I started my fellowship in endocrinology in the United Kingdom in 1975,” says Dandona, a physician with UBMD Internal Medicine, who also sees patients at the Diabetes-Endocrinology Center of Western New York.
DEPICT-1, which stands for Dapagliflozin in Patients with Inadequately Controlled Type 1 diabetes, was the first global multicenter investigation of dapagliflozin to test its efficacy and safety for Type 1 diabetes.
The double-blind, randomized, three-arm, phase 3 multicenter study was conducted at 143 sites in 17 countries, including the U.S. It was funded by AstraZeneca and Bristol-Myers Squibb, the companies that partnered to develop dapagliflozin.
Dapagliflozin Works in Conjunction With Insulin
The results demonstrated that when this drug — a sodium glucose cotransporter-2 inhibitor (SGLT-2) — was administered as an adjunct therapy in addition to the insulin that patients with Type 1 diabetes need to survive, it significantly improved outcomes.
In the study, approximately half of the patients taking dapagliflozin reduced their A1C levels by more than .5 of 1 percent without experiencing severe drops in blood sugar (hypoglycemia). Dapagliflozin exerts its plasma glucose-lowering effects by inducing the excretion of glucose in the urine.
Dandona is currently leading a study funded by JDRF — the leading global organization funding Type 1 diabetes research — to determine if dapagliflozin and semaglutide together with insulin would provide a potent “triple therapy” for improving outcomes in Type 1 diabetes. He expects more than 60 percent of patients with Type 1 diabetes to achieve hemoglobin A1c levels below 7 percent.