Novo Nordisk combination diabetes drug effective after 1 yr-study

June 14 Sat Jun 14, 2014 11:15am EDT

June 14 (Reuters) - 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 weight gain.

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)

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