Novo Nordisk's liraglutide effective in Japan study
23 Jun 2007 15:00:09 GMT Source: Reuters
By Bill Berkrot NEW YORK, June 23 (Reuters) - Novo Nordisk's experimental <NOVOb.CO> diabetes drug, liraglutide, significantly improved blood sugar control over a range of doses in a mid-stage study of Japanese patients with type 2 diabetes, researchers said on Saturday. Nearly 75 percent of patients who received the highest dose of liraglutide got their A1c levels -- a standard measure of blood glucose -- below the target of 7 percent without incidence of hypoglycemia, or dangerously low blood sugar. That compared to just 9 percent for patients who received a placebo in the 14-week clinical trial. Data from the study of 226 Japanese patients were presented at the American Diabetes Association scientific meeting in Chicago. "A well-tolerated agent with once-daily administration that can allow a majority of patients to achieve good glycemic control with a low risk of hypoglycemia and no weight gain is very promising and will be a considerable advance in diabetes treatment," said Professor Yutaka Seino of Kyoto University Graduate School of Medicine, who led the Novo-funded study. Earlier this week, Denmark's Novo Nordisk unveiled successful results from the first of a program of five planned late-stage studies that could be used to seek approval of the medicine. Novo is the word's biggest maker of insulin products. Liraglutide is an engineered version of the human GLP-1 molecule that works by increasing the way insulin-secreting cells in the pancreas release insulin in response to glucose. It is designed to stimulate release of insulin only when glucose levels become too high. Patients began the study with baseline A1c levels of between 8.1 percent and 8.5 percent and received either once-daily liraglutide at 0.1 milligrams, 0.3 mg, 0.6 mg, 0.9 mg or a placebo. The drug's effectiveness improved as the dosing got higher but all tested doses were statistically significantly better than placebos, researchers said. Researchers said A1c reductions of 0.8 percent, 1.2 percent, 1.6 percent and 1.9 percent were seen, respectively, with increasing doses of liraglutide. At the lowest dose, 22 percent of patients achieved the ADA guideline target of A1c levels below 7 percent. That rose to 43 percent who reached the target at 0.6 mg of liraglutide, 62 percent at 0.6 mg and 75 percent at the highest dose. There were no relevant changes in body weight over the course of the study, which tested the medicine in normal-weight subjects, researchers said. In previous liraglutide studies patients taking the drug lost weight, but most type 2 diabetes studies include overweight subjects. Normal weight patients are less likely to shed pounds in a short-term study. Weight loss is considered an important advantage over some older medicines that cause some weight gain as obesity is one of the leading causes of type 2 diabetes, the most common form of the disease. In addition, patients often stop taking their medication if it causes them to add pounds. The main gastrointestinal adverse events seen with the highest dose of liraglutide compared with placebo were diarrhea, gastritis and nausea.
