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Novo Nordisk diabetes drug highly effective: study

Posted on: Tuesday, 13 June 2006, 10:07 CDT

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.

Source: REUTERS

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