Phase 3 trial of lixisenatide for treatment of type 2 diabetes

Sanofi-aventis announced results from a Phase 3 trial of its GetGoal trial program of lixisenatide in patients with type 2 diabetes. The 12-week, multicenter, randomized, double-blind study assessed the efficacy of lixisenatide as monotherapy in 361 patients with type 2 diabetes not currently receiving glucose-lowering therapy. Patients were randomized to lixisenatide two-step titration (10mcg for 1 week, 15mcg for 1 week then 20mcg; n=120); lixisenatide one-step titration (10mcg for 2 weeks then 20mcg; n=119) or placebo (n=122). Lixisenatide significantly reduced HbA1c levels in both titration groups versus placebo (p<0.0001). There was a significantly higher number of patients achieving HbA1c levels ≤6.5% with lixisenatide (31.9% two-step, 25.4% one-step) and <7% (52.2% two-step, 46.5% one-step) versus placebo (p<0.01).

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