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Amylin Pharmaceuticals, Inc. and Eli Lilly and Company announced that a randomized, double-blind, cross-over, four-week head-to-head study has found their drug Byetta provided significantly lower glucose levels in the post-meal setting when compared to main rival Januvia in diabetes mellitus type 2 patients.
The results, which mark the first reported head-to-head study directly comparing Byetta and Januvia, were presented at the 44th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Rome, Italy and will also be published in the Current Medical Research and Opinion journal.
Byetta contains exenatide, a drug which is a member of a new class of medications called incretin mimetics. It is somewhat inconvenient to use as it is administered as an injection under the skin of the abdomen, thigh, or arm, 30 to 60 minutes before the first and last meal of the day. The drug is actually a synthetic version of exendin-4, a hormone found in the saliva of the Gila monster, which is a venomous lizard native to the southwestern United States and northern Mexico.
Both Amylin and its collaborator, Indianapolis-based drug company Eli Lilly & Co., agreed to warn possible and current patients of the high risk of pancreatitis the drug poses after learning of the 30 mild cases reported so far to the FDA. Although Byetta isn’t very popular among patients because it has to be injected twice a day, Amylin said about 1 million people have been prescribed the drug.
Byetta, which is administered through injection twice a day in order to lower blood sugar in people suffering from type 2 diabetes, was released on the market in 2005. Amylin also plans to come up with the long-acting release formula which is scheduled to hit the market in 2010.
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