Lixisenatide non-inferior to exenatide for diabetes

(HealthDay)—In adults with type 2 diabetes not adequately controlled with metformin, lixisenatide once daily offers diabetes control similar to that of exenatide twice daily, with some added benefits, according to a study published online May 22 in Diabetes Care.

Julio Rosenstock, M.D., from the Dallas Diabetes and Endocrine Center at Medical City, and colleagues randomly assigned 634 adults whose type 2 diabetes was not adequately controlled with metformin (hemoglobin A1c [HbA1c], 7 to 10 percent) to 20 µg lixisenatide once daily or 20 µg exenatide twice daily.

After 24 weeks, the researchers found that lixisenatide once daily was non-inferior to exenatide twice daily in terms of least squares mean change in HbA1c, responder rate (HbA1c <7.0 percent), and improvements in fasting plasma glucose, although weight loss in the lixisenatide group was lower. The lixisenatide group had a significantly lower proportion with symptomatic hypoglycemia (2.5 versus 7.9 percent) and a significantly lower proportion with gastrointestinal events (24.5 versus 35.1 percent). The incidence of adverse events and serious adverse events were similar for both drugs.

"Add-on lixisenatide once daily in type 2 diabetes inadequately controlled with metformin demonstrated non-inferior improvements in HbA1c, with slightly lower mean weight loss, lower incidence of hypoglycemia, and better gastrointestinal tolerability compared with exenatide twice daily," Rosenstock and colleagues conclude.

The study was funded by Sanofi; several authors disclosed financial ties to pharmaceutical and biotechnology companies, including Sanofi.