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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. #