Zealand Pharma A/S, the biopharmaceutical company dedicated to the discovery and development of innovative peptide-based drugs, is pleased to note that its partner, sanofi-aventis, has today announced positive top-line results of the Phase III GETGOAL-L-ASIA trial which assessed the efficacy and safety of lixisenatide, a once-daily GLP-1 receptor agonist discovered by Zealand Pharma, in combination with basal insulin. Results of the study showed that lixisenatide, when dosed once-daily in combination with basal insulin (with or without sulfonylurea), significantly improved glycaemic control and that there were no specific safety concerns with lixisenatide in patients with Type-2 Diabetes.
Commenting on today's announcement, David Solomon, Chief Executive Officer and President of Zealand Pharma, said: "We are very encouraged by the Phase III clinical trial data which demonstrates the positive effects of combining basal insulin, including the world's leading long-acting insulin, Lantus(R), with Zealand's lixisenatide. Based on this research such a combination could have the potential to provide Type-2 Diabetes patients with significant clinical and convenience benefits."
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 an 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 baseline glycated hemoglobin (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 the screening visit. They were randomised to add either lixisenatide once-daily, or placebo to their existing treatment regimen. Sixty percent of patients were taking Lantus(R) (insulin glargine) as their basal insulin.
The study met its primary endpoint and the addition of lixisenatide once daily to the basal insulin significantly reduced A1C levels by 0.88% versus placebo (p<0.0001). The full study findings will be submitted to a medical congress for presentation.
As per the press release issued by sanofi-aventis earlier today, Marc Cluzel, M.D., PhD, Executive Vice President, Research & Development, sanofi-aventis, said: "The results of this study show that lixisenatide once-daily in combination with basal insulin provides a significant reduction in A1C. 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."
Positive study findings from the first GETGOAL MONO study with lixisenatide were presented on 20 September 2010 by sanofi-aventis at the European Association for the Study of Diabetes (EASD) 46th Annual Meeting in Stockholm, Sweden. The results showed that lixisenatide, when dosed once-daily as a monotherapy, had a significant effect on postprandial blood glucose control and A1C levels with mean decreases in body weight observed in all dose groups.
The GETGOAL Phase III clinical trial program encompasses multiple clinical trials and will assess the efficacy and safety of lixisenatide in adult patients with Type-2 Diabetes mellitus treated with various oral antidiabetic agents or insulin. The GETGOAL program started in May 2008 and enrolled more than 4,000 patients at the time that enrollment was completed at the end of 2009. The next results of the GETGOAL program are expected to be released in Q2 2011.