Europe approves dapagliflozin for Type 1 diabetes, thanks in part, to UB research

An oral medication developed to treat patients with Type 2 diabetes has been approved by the European Commission for patients with Type 1 diabetes, in large part due to pioneering research conducted and advanced by a UB researcher.

In its announcement last month 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.

DEPICT-1 was led by Paresh Dandona, MD, SUNY Distinguished Professor in the Department of Medicine in the Jacobs School of Medicine and Biomedical Sciences at UB. He was the study’s principal investigator and lead author on the paper reporting the trial’s results in The Lancet Diabetes & Endocrinology in November 2017.

“Our pioneering work has led to the licensing of dapagliflozin for Type 1 diabetes in Europe,” Dandona said. “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.

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,” said Dandona, a physician with UBMD Internal Medicine, who also sees patients at the Diabetes and 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. 

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 % 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 another Type 2 diabetes drug together with insulin might be a potent “triple therapy” for improving outcomes in Type 1 diabetes.

For more information about that study, contact Jean Hejna at 716-535-1850 or Zahid Sayeed at 716-535-1853.