UPDATE 1-Novo insulin slashes noctural hypoglycemia in study

Sat Jun 9, 2012 12:28am IST

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* Novo's drug cuts nocturnal hypoglycemia 36 pct vs Lantus

* Glucose control from Novo's degludec comparable to Lantus

* FDA delays approval decision on degludec until Oct 29

By Ransdell Pierson and Bill Berkrot

June 8 (Reuters) - Novo Nordisk's experimental long-acting insulin degludec was as effective in lowering blood sugar as Sanofi's top-selling 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 Lantus, based on a measure of control over time called A1C.

The trial also measured whether degludec could cut incidents of hypoglycemia, the most feared side effect of insulin in which blood sugar drops to levels that can cause fainting or hurt heart function. Doctors and patients are particularly concerned about overnight, or nocturnal, hypoglycemia because patients are asleep and unable to recognize or address the problem.

Overall hypoglycemia rates were statistically similar for both drugs, known as basal insulins, in the 52-week, 1,030-patient study. But the rate of overnight hypoglycemia was 36 percent lower for those taking the injectable Novo Nordisk drug, compared with Lantus.

"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. Investors had expected the FDA to render its decision on the drug by July 29.

The Novo drug and an experimental basal drug being developed by Eli Lilly and Co, if approved, would attempt to wrest away a big chunk of Lantus' annual $5 billion in sales. The Sanofi drug owns some 80 percent of the basal insulin market.

Novo has tested degludec in a large number of trials, among patients with type 1 diabetes, the less common, more severe form of the disease that typically begins in childhood, and type 2 diabetes, which is highly linked to obesity.

Patients with type 1 diabetes take some form of basal insulin, as well as rapid-acting insulins at mealtimes. The basal insulin is supposed to keep blood sugar levels consistent over long periods. Many patients with type 2 diabetes start with oral drugs, but many eventually require insulin.

Similarly impressive reductions of hypoglycemia have been seen in a number of trials of degludec in both type 1 and type 2 patients, said 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," Zinman said.

Zinman said patients taking degludec in his study developed slight weight gains, comparable to those seen with Lantus. 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 percent of them having type 2, according to the International Diabetes Federation.

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