Sanofi-Aventis presents strong date for once-daily lixisenatide in combination with basal insulin; settles with Proteome

French drug major Sanofi-Aventis (Euronext: SAN) has announced the top-line results of the Phase III GETGOAL-L-ASIA study assessing the efficacy and safety of lixisenatide, a once-daily GLP-1 receptor agonist, in combination with basal insulin, showing that its product significantly improved glycemic control. The study also confirmed that there are no specific safety concerns with lixisenatide in patients with type 2 diabetes. The drug is licensed from Danish firm Zealand Pharma.

“The results of this study show that lixisenatide once-daily in combination with basal insulin provides a significant reduction in A1C,” said Marc Cluzel, executive vice president, R&D, at Sanofi-Aventis. “Adding lixisenatide, a new GLP-1 with a strong post-prandial glucose effect, to a basal insulin may offer patients a new treatment approach to better control glucose and prevent long-term complications,” he noted.

The GETGOAL-L Asia study was a 24-week, double-blind, placebo-controlled, two-arm parallel-group, multicenter trial and it assessed the safety and efficacy of lixisenatide as add-on therapy in a total of 311 Asian patients with type 2 diabetes insufficiently controlled with basal insulin (with or without sulfonylurea). Patients in the study had a baseline A1C levels between 7 and 10%; were 20 years of age or older, and were diagnosed with type 2 diabetes for at least one year before screening visit. They were randomized to add either lixisenatide once-daily, or placebo to their existing treatment regimen. 60% of patients were taking Lantus (insulin glargine) as their basal insulin.