PARIS, June 14, 2014 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) announced today that Lyxumia® (lixisenatide) met the primary endpoint in an 8-week head-to-head pharmacodynamic study versus liraglutide, showing a significantly more pronounced post-prandial (after-meal) glucose (blood sugar) lowering effect after a test-meal than liraglutide when both were added to optimally titrated Lantus® (insulin glargine). Lowering of post-prandial glucose was measured as change from baseline in incremental area under the glucose curve for 4 hours after a standardized solid breakfast, at week 8.
Findings also showed that while both lixisenatide and liraglutide lowered blood glucose (HbA1c) when added to optimally titrated insulin glargine, lixisenatide treatment resulted in fewer reports of gastrointestinal adverse events, a lower mean increase in heart rate and smaller increases from baseline to week 8 in pancreatic enzyme (amylase and lipase) levels. The most commonly reported adverse events in the study were symptomatic hypoglycemia and nausea. Symptomatic hypoglycemia was more frequent in the lixisenatide group compared to the liraglutide group. (Full results are available in the Results of Analysis section.) Lixisenatide is currently approved in Europe and an investigational drug in the United States, where it is not approved.
"In this Phase II head-to-head study we saw a significant difference in the post-prandial glucose lowering effects of lixisenatide and liraglutide, two GLP-1 receptor agonists, with similar overall blood sugar reductions," said Riccardo Perfetti, Senior Medical Officer, Vice President Global Medical Affairs, Diabetes Division, Sanofi. "The results showed that both medicines reduced blood glucose, but we found that lixisenatide did this with a greater delay in gastric emptying, and its use was associated with differences in safety and tolerability compared to liraglutide. These differences are interesting and could be further explored to determine whether differences in gastric emptying benefit patients by lowering the post-prandial glucose excursion and whether gastric emptying corresponds to differences in safety and tolerability."
These results were presented at the 74th Scientific Sessions of the American Diabetes Association, San Francisco, CA. The abstract is titled: Effect of Lixisenatide vs Liraglutide on Glycemic Control, Gastric Emptying, and Safety Parameters in Optimized Insulin Glargine T2DM +/- Metformin. (Meier et al. Poster presentation #1017-P, June 14, 2014).
About Lixisenatide
In Europe, Lyxumia® (lixisenatide) is approved as a once-daily prandial glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of patients with type 2 diabetes mellitus. It remains under investigation in the U.S. GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells.
Lyxumia was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), www.zealandpharma.com, and was approved in Europe in 2013 for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control. Lyxumia is currently approved in over 40 countries worldwide for the treatment of adults with type 2 diabetes, with commercial launches in Europe, Japan, Mexico and other markets. Sanofi plans to resubmit the New Drug Application for lixisenatide in the United States in 2015, after completion of the ELIXA cardiovascular outcomes study. Lyxumia is the proprietary name approved by the European Medicines Agency and other health authorities for the GLP-1 RA lixisenatide.
The Lyxumia pen is the winner of a number of innovative design awards, including the Good Design Award 2012 and the iF Product Design Award. The variant of the Lyxumia pen used in Japan won the Good Design Award (G Mark) 2013.
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