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New Diabetes Drug Performs Well In Trials

Posted by Chrissie Cole
Friday, September 26, 2008 8:21 AM EST
Category: Major Medical
Tags: FDA & Prescription Drugs, Diabetes, Diabetes Drugs, Drug Products, Liraglutide, Byetta, Amaryl, Amylin Pharmaceuticals, Eli Lilly, Novo Nordisk, Pancreatitis


IMAGE SOURCE: Wikimedia Commons / human insulin / author: Pdeitiker

A new class of diabetes drugs has shown promising results in a clinical trial conducted to help bring it to market, researchers report.

If approved, liraglutide would be the second GLP-1 diabetes medicine approved by the FDA for sale in the U.S. The first is exenatide (Byetta), which was approved in 2005.

Results of the trial have been given to the FDA and they will determine whether to approve the drug for use in the U.S. It should be out sometime in the first half of 2009.

Byetta and Liraglutide are analogs of a hormone known as GLP-1 (glucagon-like peptide-1), which works to stimulate insulin production while expanding insulin-making beta cells in the pancreas. A related class of diabetes drug, the DPP-4 inhibitor, blocks an enzyme that breaks down GLP-1.

Liraglutide, like other GLP-1 versions, has all the advantages of natural molecule with longer-lasting activity said Dr. Sten Madsbad, a professor of endocrinology at the University of Copenhagen in Denmark, who wrote an accompanying editorial.

“It starts by stimulating the production of insulin,” Madsbad said.” Then, it promotes glucagon release from the pancreas. It also inhibits appetite and therefore the patient will eat less.”

Glucagon is a hormone that helps manage blood levels of sugar.

Two patients taking the drug, Byetta, have died, and four are recovering apparently from damage to the pancreas. Researchers are unsure, at this time, if liraglutide will have the same rare and dangerous side effects.

Both liraglutide and Byetta have similar side effects which can include diarrhea, nausea and vomiting, although they tend to subside during the first month of use.

One caveat to the DPP-4 inhibitor is that DPP-4 plays a role in immunity and therefore patients taking these types of drugs have an increased risk of developing infections.

The study, by Alan Garber, MD, PhD of Baylor College of Medicine and colleagues, compared liraglutide and Amaryl, which is in a class of drugs called sulfonylureas, which stimulates insulin secretion.

For the trial, 746 patients diagnosed with early type-2 diabetes were given a once-daily either a 1.2 mg or 1.8 mg dose of liraglutide by injection or Amaryl once daily oral tablet. The patients taking liraglutide were given dummy pills; those taking Amaryl were given a harmless placebo.

Prior to treatment starting, patients’ HbA1c scores – a measure of long-term blood sugar control – were recorded between 7 to 11 percent.

After a year researchers found:

» In patients taking 1.8 mg of liraglutide HbA1c levels dropped 1.14%

» In patients taking 1.2 mg of liraglutide HbA1c levels dropped 0.84%

» In patients taking Amaryl HbA1c levels dropped 0.51%

» 51% of patients taking 1.8 mg doses of liraglutide were able to reach the American Diabetes Association recommend HbA1c target level of 7.0% or less.

» 43 percent of patients taking 1.2 mg doses of liraglutide were able to reach recommended HbA1c levels.

» 28 percent of patients taking Amaryl reached target HbA1c levels.

Most of the patients taking Amaryl gained weight while those taking liraglutide notably lost weight. Weight loss that occurred during the first 16 weeks of the trial was maintained a year after the follow up.

Liraglutide was also more effective in reducing patient’s blood pressure than that of Amaryl.

“Liraglutide is effective and safe as initial drug therapy for the treatment of type-2 diabetes and has advantages over other drugs used in monotherapy, such as greater weight loss, the number of [too-high-blood-sugar] events, and high blood pressure,” researchers concluded

The study is published in the September online issue of The Lancet and funded by Novo Nordisk, the maker of liraglutide. #

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