* 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 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
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.