Sanofi: Lyxumia won't significantly increase hypoglycemia risk

PARIS — New results from a late-stage clinical trial of a Sanofi drug for Type 2 diabetes indicated that the drug can reduce blood sugar in patients without increasing the risk of causing the blood sugar levels to dip too low, the French drug maker said Tuesday.

Sanofi, which shortened its name earlier this month from Sanofi-Aventis, announced results of the phase-3 “GetGoal-L” trial of Lyxumia (lixisenatide), saying that when used as an add-on therapy with basal insulin and with or without metformin, the drug “significantly” reduced HbA1C levels, compared with placebo, without significantly increasing the risk of hypoglycemia. The trial, part of the broader “GetGoal” phase-3 study program, enrolled 495 patients who received either Lyxumia or placebo.

“These positive efficacy and safety results are another important milestone in the GetGoal clinical trial program and show the potential value of adding Lyxumia to basal insulin to improve glycemic control,” Sanofi global diabetes division SVP Pierre Chancel said. “The findings from this and previous studies reinforce the continuing positive trend demonstrating the potential of lixisenatide to improve the lives of people with Type 2 diabetes.”