June 13, 2006

Novo Nordisk diabetes drug highly effective: study

By Bill Berkrot

NEW YORK (Reuters) - An experimental diabetes drug by Novo
Nordisk dramatically improved blood sugar levels and lowered
weight in type 2 diabetes patients in a mid-stage clinical
trial, researchers said on Tuesday.

The drug, liraglutide, proved effective as a stand-alone
therapy without incidents of hypoglycemia, or dangerously low
blood sugar, according to data presented at the American
Diabetes Association scientific meeting in Washington.

The 14-week, 165-patient study tested liraglutide at doses
of 0.65 milligrams, 1.25 mg and 1.9 mg against a placebo, with
the medicine achieving statistical significance versus placebo
at all three doses. At the highest dose, hemoglobin A1C levels
-- a common measure of blood sugar -- was driven down by an
average of 1.74 percent, researchers said.

"This was more than highly statistically significant, it
was one of the biggest reductions in hemoglobin A1C of any
studies seen before," Dr. Sten Madsbad, professor of
endocrinology at the University of Copenhagen and the study's
principal investigator, said in an interview.

In addition, patients injected with the highest dose of
liraglutide lost an average of 3 kilograms (6.6 pounds) over 14
weeks compared with a loss of 1.2 kg (2.6 pounds) in the
placebo group.

Weight loss is considered a major advantage over some older
diabetes drugs that can cause weight gain, as obesity is the
leading cause of type 2 diabetes. Patients often stop taking
medication if they start to put on weight.

Byetta, a new diabetes drug from Eli Lilly and Co., has
enjoyed an extremely successful launch in part because it also
promotes weight loss. Patients lost an average of 5 pounds in a
30-week trial of Byetta that doubled to 10 pounds after two
years in an extension study presented at the ADA meeting.

Madsbad said the weight loss seen with liraglutide was
particularly impressive as there were no lifestyle changes,
such as diet or exercise components, involved in the study.

"We need longer studies of one or two years to learn about
how much weight loss can be induced by liraglutide," he said.

Madsbad said none of the patients in the study had gotten
their A1C levels below the ADA guideline of 7 percent with
previous medications. About half of them saw levels fall below
the desired 7 percent after 14 weeks on liraglutide.

He said researchers also saw a surprising added benefit of
lower blood pressure in the liraglutide patients.

Alan Moses, Novo's associate vice president for clinical
research and medical affairs, said the phase 2 data was
exciting, but he cautioned that it was still early days.

"We need to confirm all of these findings by reproducing
them in our large phase 3 program," he said. "We need to see a
much larger number of patients over a longer period of time."

Liraglutide, an engineered version of the human GLP-1
molecule, works by improving the way insulin secreting cells in
the pancreas release insulin in response to glucose.