Novo diabetes drug tops older medicine at two years

NEW YORK 08 june 2009 – Novo Nordisk A/S's experimental diabetes drug liraglutide was significantly better at helping patients control blood sugar than an older common medicine after two years of treatment, according to data from a clinical trial.

Among patients who completed the two-year trial, 58 percent of those who took the 1.8 milligram dose of the closely watched Novo injectable drug reached and maintained target blood sugar levels compared with 37 percent of patients treated with glimepiride, the company said.

American Diabetes Association (ADA) guidelines call for A1C levels -- a commonly used measure of blood sugar over time -- of 7 percent or less.

The 1.8 mg liraglutide patients saw A1C levels on average drop by 1.1 percent compared with a 0.6 percent reduction with glimepiride.

Patients taking liraglutide once daily also lost an average of 2.7 kilograms (6 pounds), while glimepiride patients gained 1.1 kg (2.4 pounds). Weight loss is an important advantage in type 2 diabetes patients, as most tend to be overweight and obesity is one of the leading causes of the disease, which is reaching epidemic proportions.

"People overall lose weight with liraglutide. That's a significant value-added benefit to this class of drugs," Dr. Alan Garber from the Baylor College of Medicine in Houston and one of the study's lead researchers said in an interview.

The data, which also showed far fewer incidents of hypoglycemia, or dangerously low blood sugar, with liraglutide, were presented on Sunday at the ADA scientific meeting in New Orleans.

Glimepiride, sold by Sanofi-Aventis as Amaryl, belongs to an old class of diabetes medicines called sulfonylureas, which are typically a second drug added to Type 2 diabetes therapy after metformin.

Liraglutide belongs to a newer GLP-1 class of injectable drugs that work by stimulating release of insulin only when blood sugar levels are high.

"We were able to show that the safety risks of hypoglycemia are 10 times greater with the sulfonlyurea than with liraglutide because it has a completely different biochemical mechanism of action," Garber said.

"To top it all off the blood sugar control with this agent is almost twice as good as with a maximum dose of what most people consider to be the best of the sulfonylureas," he added.

The most common side effects seen with liraglutide in the study were nausea, diarrhea and vomiting, and most were transient, researchers said.

Liraglutide is awaiting U.S. and European approval decisions, but its once-projected multibillion-dollar-a-year potential has taken a hit over safety concerns raised by an advisory panel to the U.S. Food and Drug Administration.

A European panel recommended approval, but the U.S. panel was split over worry about thyroid tumors found in mice and rats tested with the medicine.

U.S. approval is critical to the commercial success of the drug that would compete with Byetta, a GLP-1 sold by Amylin Pharmaceuticals Inc and Eli Lilly and Co.

"My patients were really unhappy to go off the trial because they liked liraglutide," Garber said. "They like the fact that they lost some weight."