Sanofi has released additional positive results from the global GetGoal Phase III development program with Lyxumia (lixisenatide) for the treatment of type 2 diabetes. Lyxumia (lixisenatide), a once-daily GLP-1 receptor agonist, was invented by Zealand Pharma and global rights are with Sanofi.
GLP-1 (Glucagon-like peptide-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 to stimulate insulin secretion by pancreatic beta cells. GLP-1 receptor agonists is an established class of diabetes drugs approved by regulatory authorities and marketed globally as an add-on treatment for patients with type 2 diabetes. Their use is endorsed by the European Association for the Study of Diabetes, the American Diabetes Association, the American Association of Clinical Endocrinologists and the American College of Endocrinology.
GetGoal-L is the fifth of nine studies to report positive data within the GetGoal Phase III clinical program, and the second study after GetGoal-L Asia to investigate the benefits of lixisenatide 20µg once-daily combined with basal insulin, including Lantus. The results confirm those previously reported, and this time in a broader population including both Caucasian and Asian patients.
Top-line results from the GetGoal-L study showed that lixisenatide as an add-on therapy to basal insulin (with or without metformin), achieved its primary efficacy endpoint of significantly reducing HbA1c levels without significantly increasing the risk of hypoglycemia versus placebo for patients with type 2 diabetes. In addition, patients treated with lixisenatide had significantly improved postprandial plasma glucose after a test meal. Patients in the lixisenatide arm of the study also reported a significant reduction in body weight.
The full study results from GetGoal-L are planned to be presented at a future medical congress.