Sanofi-aventis announced today that lixisenatide, a once-daily GLP-1 receptor agonist under development for people with type 2 diabetes, achieved its primary efficacy objective of significant HbA1c reduction and improved glycemic control from baseline versus placebo. The results also showed that people treated with lixisenatide had a significant decrease in body weight, and that lixisenatide did not significantly increase the risk of symptomatic hypoglycemia compared with a placebo.
GLP-1 is a naturally occurring body hormone that helps to maintain normal blood sugar levels. Patients with type 2 diabetes have defects in their GLP-1 system that contribute to inadequate insulin release which, in turn, result in increased glucose levels. GLP-1 drugs suppress glucagon secretion by the pancreatic alpha cells and stimulate insulin release by the pancreatic beta cells when glucose levels become too high.
Sanofi’s diabetes offering currently includes the Lantus, a long-acting insulin, as well as the rapid-acting insulin Apidra. If Lixisenatide wins marketing approval it will compete with other GLP-1 receptor agonists, Novo Nordisk’s Victoza and Amylin and Eli Lilly’s Byetta. In November 2010, Novo announced it expected annual Victoza sales to reach $1 billion by 2012.