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 standalone therapy without incidents of hypoglycemia, or dangerously low blood sugar, according to data presented at the American Diabetes Association scientific meeting in Washington.
Mads Krogsgaard Thomsen, Novo’s chief science officer, told Reuters he believed the medicine could become a “blockbuster” with annual sales of more than $1 billion a year.
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 6.6 pounds over 14 weeks compared with a loss of 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. and Amylin Pharmaceuticals Inc., 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.
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.
Novo’s Thomsen said the Danish company planned to file liraglutide for approval in 2008 and should be able to launch it in 2009, a few months ahead of a rival long-acting version of Byetta.