Published September 8, 2016
Researchers in the Division of Endocrinology, Diabetes and Metabolism have found that dapagliflozin, designed for Type 2 diabetes, can benefit patients with Type 1 diabetes.
The findings come on the heels of their previous studies that found Type 1 diabetics benefit from insulin and liraglutide, another drug designed and marketed to treat Type 2 diabetes, in a randomized controlled trial. The new study maintains the global leadership of the UB team in the treatment of Type 1 diabetes since their first publication on the use of liraglutide in 2011.
In a paper published Aug. 4 in the Journal of Clinical Endocrinology and Metabolism, the researchers reported that patients with Type 1 diabetes saw improved blood glucose control with a “triple therapy” of insulin, liraglutide and dapagliflozin.
Thirty Type 1 diabetics, who were already taking liraglutide and insulin to manage their diabetes, participated in a randomized, placebo-controlled clinical trial. Participants were between the ages of 18 and 75, and 20 of them were randomly assigned to receive 10 milligrams of dapagliflozin daily for 12 weeks. The other 10 received a placebo during the same period.
“Since liraglutide produces improvements most impressively in patients with higher body mass index and higher hemoglobin A1C, it is clear that we need other agents that act independently of insulin since Type 1 diabetics have no beta cells that produce insulin,” explained senior author on the paper Paresh Dandona, MD, PhD, SUNY Distinguished Professor of medicine and chief of endocrinology, diabetes and metabolism.
Hemoglobin A1C — patients’ average blood glucose over a 90-day period — declined by 0.66 percent among participants who received the triple therapy, while there was no significant change in the placebo group. Fourteen people on the triple therapy lost weight, with weight loss averaging four pounds. Patients in the placebo group did not lose weight.
Twenty-six participants completed the study. Two of the participants receiving the triple therapy developed diabetic ketoacidosis, a dangerous complication that occurs when acids and substances called ketones build up in the blood due to lack of insulin. This occurred within two days of researchers increasing the daily dapagliflozin dose to 10 milligrams from 5 milligrams. Both people were withdrawn from the study.
“Our data also show for the first time that all patients on dapagliflozin experience an increase in ketones,” Dandona says. “This may predispose people to developing diabetic ketoacidosis, particularly among those who have a marked reduction in insulin from taking liraglutide together with dapagliflozin and who have consumed too few carbohydrates.”
“Our study sheds light on potential strategies for preventing diabetic ketoacidosis, but more research is still needed in this area.”
Dandona says the data suggest that insulin dose reductions should be minimized and that the higher dose of dapagliflozin should not be used in such patients.
Other Division of Endocrinology, Diabetes and Metabolism faculty who are co-authors are:
Other co-authors are: Nitesh D. Kuhadiya, MD, first author on the study; Aditya Mehta, MBBS; Manisha Garg, MD; Salman Khan, Jeanne Hejna and Barrett Torre.