New Diabetes Drug Shows Promise in Trial
MONDAY June 8, 2009 -- An experimental diabetes drug called liraglutide appears to outperform exenatide (Byetta), the only currently approved drug in its class, a study funded by liraglutide's maker, Novo Nordisk, shows.
Liraglutide is a laboratory-made version of glucagon-like peptide-1 (GLP-1), a hormone produced by the body that stimulates insulin production. Several members of the GLP-1 family are in clinical trials.
In the new phase III trial -- usually the last kind done before marketing approval is sought -- injecting liraglutide once daily showed greater benefits in terms of blood sugar control and appeared to be easier on patients than Byetta, which is injected twice a day, according to a report published online June 8 in The Lancet to coincide with its presentation at the American Diabetes Association's annual meeting in New Orleans.
Patients taking liraglutide also lost more weight during the 26-week trial than those taking Byetta, the researchers report. Byetta was approved by the U.S. Food and Drug Administration in 2005.
"The results suggest that liraglutide might be a treatment option for type 2 diabetes, especially when weight loss and risk of hypoglycemia are major considerations," wrote a team led by Dr. John Buse, of the University of North Carolina School of Medicine.
In the study, 464 adult patients with inadequately controlled type 2 diabetes were randomized to receive either liraglutide at 1.8 milligrams once daily or Byetta at 10 micrograms two times per day. All of the participants were also taking the maximum tolerated doses of either the standard diabetes drug metformin, sulphonylurea or both.
Patients on liraglutide showed better glucose control based on their blood HbA1C measurements, which track blood sugar fluctuations over time, the team reported. The experimental drug was also more than twice as good as Byetta at reducing mean fasting blood glucose levels. On the other hand, Byetta performed better than liraglutide at reducing blood sugar immediately after meals, suggesting that liraglutide exerts its effects prior to food intake, or during fasting, according to the authors.
Patients on liraglutide lost an average of about seven pounds during the trial, compared to about 6.4 pounds for those taking Byetta, the team said.
In a journal editorial, Drs. Christophe De Block and Luc Van Gaal, of the University of Antwerp in the Netherlands, wrote that the trial "shows that liraglutide provides greater improvements in glycemic control and is better tolerated than exenatide."
The study follows a similar trial, published in The Lancet last September, which found liraglutide performed better than a now-standard medication from a different class, glimepiride (Amaryl). That trial was also sponsored by Novo Nordisk.
Like the other GLP-1 versions, liraglutide has all the advantages of the natural molecule, with longer-lasting activity, said Dr. Sten Madsbad, a professor of endocrinology at the University of Copenhagen in Denmark, who wrote an editorial that accompanied the September study.
"First, it stimulates insulin production," Madsbad explained. "Then it also promotes glucagon release from the pancreas. It also changes appetite, and therefore you eat less." Glucagon is a hormone that helps manage blood sugar levels.
"We want more medications that have this type of profile," Dr. Alan Garber, a professor of medicine, biochemistry and cell and molecular biology at Baylor College of Medicine, in Houston, and lead author of the liraglutide/glimepiride trial, said at the time of its release.
"It is very well-tolerated, has few side effects and can lead to weight loss," Garber said. "Most diabetes medications now produce weight gain, and that is very discouraging to our patients."
In related news, also published simultaneously in The Lancet and at the diabetes association meeting, researchers reported data from a phase II trial for another experimental diabetes drug, aleglitazar. That trial assessed the safety and effectiveness of the drug, one of a class of medications called PPAR co-agonists that affect both blood sugar control and fat.
In the 16-week trial, 332 patients with type 2 diabetes received either once-daily doses of aleglitazar (at varying doses), the diabetes drug pioglitazone (Actos), or a placebo.
At lower doses, aleglitazar appeared safe and effective, with less incidence of heart failure or edema than either Actos or placebo; it produced less weight gain than Actos when given at the 150-microgram dose.
"The favorable balance in the safety and efficacy profile of aleglitazar represents encouraging short-term clinical data for this agent, and provides good evidence to enter phase III investigation," wrote a team led by Dr. Robert R. Henry of the University of California, San Diego.
The study was funded by aleglitazar's maker, F. Hoffmann-La Roche AG.
Today's oral medications for diabetes are described by the American Diabetes Association.
Posted: June 2009
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