Largest of nine trials shows lixisenatide significantly reduces GLP-1 levels.
Zealand Pharma and partner sanofi-aventis reported positive data from the largest of its nine-trial Phase III program evaluating the once-daily GLP-1 agonist lixisenatide in the treatment of patients with type 2 diabetes. The placebo-controlled GetGoal-S study showed lixisenatide therapy led to significant reductions in HbA1c levels and body weight, and improved glycemic control from baseline. The 24-week study involved 859 patients with type 2 diabetes whose disease was inadequately controlled by sulfonylureas, with or without metformin. Enrolled patients were randomized to receive either lixisenatide or placebo in step-wise increasing doses.
“The GetGoal-S study is one of the largest and most important studies within the entire GetGoal Phase III program,” remarks David Solomon, Zealand’s president and CEO, on release of the latest Phase III trial data. “The significant HbA1c reduction, improved glycemic control, and decrease in body weight observed in the study is a critical regulatory step.”
In March Zealand and sanofi-aventis reported positive data from the Phase III GetGoal-X trial, which compared lixisenatide therapy with treatment using exenatide (Byetta®). In September 2010, the partners reported top-line results from the Phase III GetGoal-L-ASIA trial in Asian patients, which showed that adding lixisenatide to existing basal insulin treatment resulted in significantly reduced HbA1c levels compared with basal insulin plus placebo.
Sanofi-aventis is developing Zealand’s lixisenatide both as monotherapy and in combination with sanofi-aventis’ Lantus® insulin product. Under terms of the agreement, signed back in 2003, the French drug giant is responsible for development and commercialization of the lixisenatide family. Danish firm Zealand could receive up to €235 million in milestone payments and double-digit royalties on worldwide sales of lixisenatide monotherapy and combination treatments that include the drug.