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Sanofi-aventis Phase III study of Lixisenatide meets primary endpoint

Sanofi-aventis' randomized, open-label, active-controlled, two-arm parallel-group, multicenter GetGoal-X Phase III study of Lixisenatide meet primary point of non-inferiority in HbA1c reduction from baseline, compared with Exenatide twice-daily.

Lixisenatide, a glucagon-like peptide-1 agonist (GLP-1), is in development for the treatment of patients with type 2 diabetes mellitus.

Sanofi-aventis claims that GetGoal-X is the first head-to-head study comparing Lixisenatide with another GLP-1, demonstrates the efficacy of Lixisenatide once-daily in reducing HbA1c in people with type 2 diabetes and also shows a better hypoglycemia profile.

The initial results demonstrated that fewer people with type 2 diabetes treated with Lixisenatide once-daily reported hypoglycemic events versus patients treated with Exenatide.

Sanofi-aventis Global Diabetes senior vice president Pierre Chancel said Lixisenatide clinical development program exemplifies their commitment to people with diabetes and their ambition to help them manage their condition more effectively.