Novo diabetes drug tops Byetta in comparison study

Mon Jun 8, 2009 10:50pm BST
 
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 * Liraglutide lowers A1C 1.12 pct vs Byetta 0.79 pct
 * 54 pct hit A1C target vs 43 pct for Byetta
 * Similar weight loss seen with both drugs
 By Bill Berkrot
 NEW YORK, June 8 (Reuters) - Novo Nordisk's (NOVOb.CO)
experimental Type 2 diabetes drug liraglutide led to greater
reduction in blood sugar than Byetta, a similar medicine sold
by Amylin Pharmaceuticals Inc (AMLN.O) and Eli Lilly and Co
(LLY.N), in a head-to-head comparison trial.
 Diabetics who took liraglutide in the 464-patient trial
experienced a greater drop in A1C level of 1.12 percent compared
with a reduction of 0.79 percent in those taking Byetta, known
chemically as exenatide, researchers said. The result was
statistically significant, researchers said.
 A1C is a commonly used measure of blood sugar over time.
American Diabetes Association (ADA) guidelines call for A1C
level of 7 percent or less.
 Fifty-four percent of patients in the liraglutide group
achieved target A1C levels compared with 43 percent of those who
took Byetta, according to data presented at the ADA scientific
meeting in New Orleans on Monday and published in The Lancet.
 Both belong to a newer GLP-1 analog class of injectable
Type 2 diabetes drugs that work by stimulating release of
insulin only when blood sugar levels are high.
 Liraglutide is injected once a day and Byetta twice daily,
although the investment community is more anxious to see
liraglutide compared with an experimental version of exenatide
that is injected just once a week. Both are awaiting approval
decisions from U.S. health regulators, with some nagging safety
concerns making approval less than certain.
 Unlike some older diabetes medicines that cause weight
gain, patients taking the GLP-1 drugs usually lose weight. That
is a significant added benefit for treating a disease reaching
epidemic proportions in which most of the patients tend to be
overweight or obese.
 In this study, liraglutide patients lost an average of 3.2
kilograms (7 pounds) and Byetta patients on average lost 2.9 kg
(6.4 pounds).
 "The clinical benefits that liraglutide provides -- from
greater glucose lowering to weight loss to better tolerability
and improvements in beta-cell function -- represent a
clinically meaningful treatment advance for patients with Type
2 diabetes," Dr. John Buse, director of the Diabetes Care
Center at the University of North Carolina School of Medicine
and one of the study's lead investigators, said in a statement.
 Both drugs were well-tolerated, but nausea was less
persistent and incidence of hypoglycemia, or low blood sugar,
was less common with liraglutide than with exenatide,
researchers said.
 A recent advisory panel to the U.S. Food and Drug
Administration was split on whether to recommend liraglutide
approval over concern about thyroid tumors found in mice and
rats tested with the medicine.
 (Reporting by Bill Berkrot, editing by Matthew Lewis)


 

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