First Reported Head-to-Head Study Showed BYETTA(R) (exenatide) Injection Provided Greater Reduction in Post-Meal Glucose Levels
September 09 2008 - 7:30AM
PR Newswire (US)
Patients Taking BYETTA Also Reduced Food Intake ROME, Sept. 9
/PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc.
(NASDAQ:AMLN) and Eli Lilly and Company (NYSE:LLY) today announced
results from a randomized, double-blind, cross-over, four-week
head-to-head study demonstrating that BYETTA(R) (exenatide)
injection, a GLP-1 receptor agonist, provided significantly lower
glucose levels in the post-meal setting when compared to
Januvia(TM) (sitagliptin), a DPP-4 inhibitor. Additionally,
patients treated with BYETTA reduced post-meal glucagon, showed
more efficient use of their body's own insulin and decreased their
food intake when compared to Januvia. This is the first reported
head-to-head study directly comparing the therapeutic mechanisms of
action (MOA) of BYETTA and Januvia. The findings were presented at
the 44th Annual Meeting of the European Association for the Study
of Diabetes (EASD) in Rome, Italy. The study will also be published
in the peer-reviewed journal, Current Medical Research and Opinion.
"There has been some confusion in the marketplace about the
therapeutic differences between BYETTA and Januvia, and data from
this first head-to-head study showed a clear difference in the MOAs
and resultant short-term clinical effects between these two agents.
BYETTA works directly on the GLP-1 receptor, whereas Januvia
indirectly affects GLP-1 levels," said Ralph DeFronzo, M.D.,
professor of medicine and chief of the Diabetes Division at the
University of Texas Health Science Center in San Antonio and a
clinical trial investigator on this study. "Patients on BYETTA
experienced significantly lower post-meal glucose levels, improved
measures of beta cell function and decreased food intake." The
primary endpoint of this four-week study compared the effect of
BYETTA and Januvia on 2-hour post-meal glucose. Secondary endpoints
included post-meal glucagon, insulin secretion rate, gastric
emptying, and food intake. Patients were randomly assigned to
treatment with either BYETTA (5 mcg twice daily for the first week
followed by 10 mcg twice daily for the second week) or Januvia (100
mg once daily) for two weeks; patients were then switched to the
alternate therapy for the remaining two weeks. At baseline and at
the end of each two week treatment period, patients underwent a
standard meal test and other evaluations to assess each drug's
effects on various measures of post-meal glucose control,
indicators of beta cell function and other parameters. Study
Findings In response to a standard meal, patients (evaluable
population, N=61) treated with BYETTA had significantly improved
post-meal glucose levels two hours after the standard meal when
compared to Januvia (133 mg/dL vs. 208 mg/dL at 2 hours
respectively, baseline: 245 mg/dL; P
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