Drug & Device Development
(Reuters Health ADA) – Novo Nordisk’s experimental long-acting insulin degludec (Tresiba) was as effective in lowering blood sugar as Sanofi’s top-selling insulin glargine (Lantus) and led to far fewer incidents of potentially dangerous overnight hypoglycemia, according to results from a late-stage study.
Degludec met the primary goal of the study in patients with type 2 diabetes by lowering blood sugar as well as insulin glargine, based on hemoglobin A1C.
The trial also measured whether degludec could cut incidents of hypoglycemia, particularly overnight.
Overall hypoglycemia rates were statistically similar for both drugs in the 52-week, 1,030-patient study. But the rate of nocturnal hypoglycemia was 36% lower for those using degludec, compared with insulin glargine.
”That’s quite a remarkable reduction,” the study’s lead researcher, Dr. Bernard Zinman, said in a telephone interview.
”One of the things that we want to really avoid in managing diabetes is hypoglycemia. This is a significant advance in the use of basal insulin in managing type 2 diabetes,” he said.
Deglucec, which is awaiting a U.S. approval decision, suffered a regulatory setback on Friday when the Food and Drug Administration extended its review of the new ultra-long acting insulin until Oct. 29 to consider further data. The expectation was that the FDA would render its decision on the drug by July 29.
Similarly impressive reductions of hypoglycemia have been seen in a number of trials of degludec in both type 1 and type 2 patients, said Dr. Zinman, professor of medicine at the University of Tornoto. He was to present data from his study on Saturday at the annual scientific sessions of the American Diabetes Association in Philadelphia.
”I see this as being an insulin that people will first of all use in those patients that are having hypoglycemia, but very quickly will adopt as the insulin of choice in the context of replacing basal insulin,” Dr. Zinman said.
Dr. Zinman said patients taking degludec in his study developed slight weight gains, comparable to those seen with insulin glargine. Weight gains are a concern for diabetics because they can lead to or worsen obesity, which can aggravate their condition.
The most common side effects seen in patients taking degludec included bronchitis, gastrointestinal inflammation and headaches.
More than 360 million people worldwide suffer from diabetes with more than 90% of them having type 2, according to the International Diabetes Federation.
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