| June 14
June 14 A Novo Nordisk drug combining
its long-acting insulin degludec with its type 2 diabetes
treatment Victoza maintained superior blood sugar reduction
after one year than either medicine separately, according to
data from a late stage trial presented on Saturday.
The combination therapy also helped more patients achieve
recommended blood sugar levels and appeared to reduce side
effects of each of the drugs when taken alone.
After 52 weeks of treatment, patients taking the combination
drug IDegLira had an average 1.8 percent reduction in A1c levels
- a common measure of blood sugar over time. That compared with
an average A1c decline of 1.4 percent for the insulin and 1.2
percent for Victoza, known chemically as liraglutide.
The Danish drugmaker had previously released data from the
trial called Dual I after 26 weeks. The new data, unveiled at
the American Diabetes Association (ADA) meeting in San
Francisco, showed that IDegLira maintained its significantly
superior efficacy over an additional 26 weeks.
The average A1c level after a year was 6.4 percent for
IDegLira, 6.9 percent for insulin degludec, sold in some markets
as Tresiba, and 7.1 percent for Victoza. ADA guidelines call for
A1c levels below 7 percent. Seventy eight percent of IDegLira
patients achieved that goal versus 63 percent for degludec and
57 percent for Victoza.
"It provides unparalleled glucose lowering compared to every
other drug that's been developed in diabetes, and it does so
very safely," said Professor John Buse of University of North
Carolina School of Medicine, one of the lead investigators.
Morningstar analyst Karen Andersen is forecasting IDegLira
annual sales reaching about $1 billion.
Combination therapies for the growing type 2 diabetes health
crisis are becoming increasingly common as patients continually
require additional medicines as the disease progresses. As many
as a third of all Americans could have diabetes by 2050 if
present trends continue unabated, the ADA has cautioned.
The study included 1,663 type 2 diabetes patients whose
blood sugar was not properly controlled by metformin, the most
common initial treatment for the disease.
Patients taking IDegLira had a mean weight reduction of 0.9
pounds (0.4 kg). That compared with average weight gain of 5.1
lbs (2.3 kg) for insulin degludec and a loss of 6.6 lbs (3 kg)
for Victoza, for which Novo is seeking additional U.S. and
European approvals as a weight loss drug.
Weight loss is a particularly beneficial effect as obesity
is a leading cause of type 2 diabetes and insulin tends to cause
IDegLira also led to a 37 percent lower rate of
hypoglycemia, or dangerously low blood sugar, than the
long-acting insulin, researchers said. Victoza has been
associated with very low rates of hypoglycemia.
Buse called IDegLira "a particularly synergistic
combination" that allowed for gradual dose increases.
"The nausea and other GI side effects that are the Achilles
heel for liraglutide is reduced dramatically by the slow
titration process," he said.
(Reporting by Bill Berkrot; Editing by Grant McCool)