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 (HbA 1c) 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).Results of AnalysisThis 8-week, randomized, open-label, three-arm parallel trial, comparing lixisenatide 20 microg with liraglutide 1.2mg and 1.8mg QD in 142 patients with type 2 diabetes on optimally titrated (SMPG of 80–100mg/dL) insulin glargine treatment with or without metformin, met its primary endpoint. Results showed a greater reduction in post-prandial glucose (PPG) from baseline with lixisenatide (-240.2h.mg/dL, SE 20.0) than with liraglutide 1.2mg (-131.8h.mg/dL, SE 20.2) and 1.8mg (-157.1h.mg/dL, SE 21.0) for 4 hours after a standardized solid breakfast (p<0.0001). At week 8, HbA 1c decreased significantly from baseline (p<0.05) for all groups, and final HbA 1c levels were similar in all treatment arms (6.2 +/- 0.4 for lixisenatide, 6.1 +/- 0.3 for liraglutide 1.2mg, and 6.1 +/- 0.3 for liraglutide 1.8mg). Body weight decreased significantly in all groups (-1.61 +/- 0.47kg, p<0.05 for lixisenatide, -1.78 +/- 0.48kg, p<0.05 for liraglutide 1.2mg, and -2.42 +/- 0.49kg, p<0.0001 for liraglutide 1.8mg). Symptomatic hypoglycemia was slightly more frequent with lixisenatide (14 events with lixisenatide versus 9 and 10 events with liraglutide 1.2mg and 1.8mg, respectively). There was one case of severe symptomatic hypoglycemia in the lixisenatide arm and one case of mild asymptomatic confirmed pancreatitis in the liraglutide 1.8mg arm.