Phase 3 study of lixisenatide for the treatment of type 2 diabetes mellitus (DM)
Zealand Pharma and sanofi-aventis announced that their Phase 3 study of lixisenatide achieved its primary endpoint of non-inferiority in HbA1c reduction from baseline in patients with type 2 diabetes mellitus (DM), compared with exenatide twice-daily. This trial is a randomized, open-label, active-controlled, two-arm parallel-group, multicenter study, with a 24-week main treatment period. It compared the efficacy and safety of the two GLP-1 receptor agonists: once-daily lixisenatide vs. twice-daily exenatide as add-on therapy for people with type 2 diabetes whose condition is inadequately controlled by metformin. A total of 639 people were randomized to receive either lixisenatide or exenatide. Both groups received a stepwise increase in dose, up to a maximum daily dose of 20microg.
Lixisenatide is a glucagon-like peptide-1 agonist (GLP-1). GLP-1 is a naturally occurring peptide that is released within minutes of eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate insulin secretion by pancreatic beta cells.
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