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PHILADELPHIA — An investigational insulin being developed by Novo Nordisk significantly reduced the rate of hypoglycemia at night in adults with Type 2 diabetes, according to results of a late-stage clinical trial presented at the 72nd Scientific Sessions of the American Diabetes Association.
Novo Nordisk said during a 52-week randomized, open-label, noninferiority, treat-to-target trial, its ultra long-acting insulin degludec reduced the rate of nocturnal hypoglycemia while obtaining equivalent improvement in glucose control, compared with insulin glargine. Both insulins were given once-daily in 1,030 insulin-naïve Type 2 diabetes adults inadequately controlled with oral antidiabetic medications.
Insulin degludec was submitted for once-daily use to the Food and Drug Administration in September 2011 for regulatory review.
"Nocturnal, or night-time, hypoglycemia is a particular challenge for people living with diabetes, as these episodes are often unpredictable and difficult to detect," said Bernard Zinman, lead author and director of the diabetes center at Mount Sinai Hospital, and professor of medicine at the University of Toronto. "This study demonstrated that treatment with insulin degludec significantly reduced the rate of nocturnal hypoglycemia."