Zealand Pharma: Additional positive results from global Phase III program with lixisenatide for Type 2 Diabetes

Results show potential for an improved blood glucose level during the day, further supporting the promising therapeutic profile of lixisenatide

15-Apr-2011 - Denmark

Zealand Pharma announced the release by its partner, sanofi-aventis, of positive top-line results from the GetGoal-S Phase III study of lixisenatide, a once-daily GLP-1 agonist in development for patients with type 2 diabetes. In the study, lixisenatide achieved the primary efficacy endpoint of significant HbA1c reduction, improved glycemic control from baseline versus placebo and led to a significant decrease in body weight.

GetGoal-S, the largest of nine studies in the GetGoal Phase III clinical program, investigated the efficacy and safety of lixisenatide as an add-on therapy for patients with Type 2 diabetes whose condition was inadequately controlled by sulfonylureas, with or without metformin. GetGoal-S was a randomized, double-blind and placebo-controlled study with a 24-week treatment period. In the study, a total of 859 patients were randomized to receive either lixisenatide or placebo in step-wise increasing doses, up to a maintenance dose of 20µg daily.

Patients in the lixisenatide group experienced a significant reduction in their HbA1c levels, with a -0.74% difference versus placebo (p<0.0001) at week 24. Lixisenatide also significantly improved patients’ 2-hour post-prandial (after meal) glucose (p<0.0001) and fasting plasma glucose (p<0.0001) levels. In addition, patients treated with lixisenatide had a significant decrease in body weight (p<0.0001), versus those receiving placebo.
Results from GetGoal-S also showed that lixisenatide did not significantly increase the risk of symptomatic hypoglycemia at week 24 (p=0.23), compared with placebo.

https://www.bionity.com/en/news/131958/zealand-pharma-additional-positive-results-from-global-phase-iii-program-with-lixisenatide-for-type-2-diabetes.html