Lixisenatide Update ADA 71st Scientific Sessions

The GetGoal-X trial is a randomized, open-label, active controlled, two arm parallel groups, multicenter study with a 24 week main treatment period. GetGoal-X measured, "Efficacy and Safety of Lixisenatide Once-Daily Versus Exenatide Twice-Daily in Type 2 Diabetes Inadequately Controlled on Metformin (GetGoal-X)" [ABSTRACT 0033-LB] and included 634 subjects randomized to receive either lixisenatide or exenatide.  

Lixisenatide once daily showed non inferiority in its primary endpoint of A1C reduction when compared to exenatide twice daily. Improvements in mean fasting plasma glucose, percentage of patients achieving the study goal of A1C <7%, decrease in mean body weight were comparable between both groups. Patient discontinuation of therapy due to adverse events (mainly nausea, vomiting, and diarrhea) were also similar. However, subjects on lixisenatide experienced 6 fold fewer symptomatic hypoglycemic events than the subjects on exenatide. Thus the once daily lixisenatide demonstrates non inferior reduction of blood glucose and less hypoglycemia versus exenatide twice daily in type 2 diabetes patients. 

"Lixisenatide once daily demonstrated efficacy in blood glucose control by meeting an endpoint of non-inferiority at week 24 in a head-to-head study versus exenatide twice daily," said Julio Rosenstock, MD, director of the Dallas Diabetes and Endocrine Center at Medical City Dallas and lead investigator of the GetGoal-X trial. 

In the GetGoal-L Asia trial, Asian patients with type 2 diabetes insufficiently controlled by basal insulin ± sulfonylurea were given lixisenatide once daily. Data in the trial confirmed that, "Lixisenatide Significantly Improves Glycemic Control in Asian Patients with Type 2 Diabetes Insufficiently Controlled on Basal Insulin ± Sulfonylurea."  

Glycemic control was measured by the number of patients reaching the target A1C <6.5% or <7% versus placebo after 24 weeks. Lixisenatide significantly improved A1C levels, improved two hour post prandial glucose levels, and was well tolerated. As expected more patients on Lixisenatide experienced hypoglycemia but no cases of severe hypoglycemia were reported.

The two trials conducted in animals also showed positive results. The first study showed the "Cardioprotective Effect of the GLP-1 Receptor Agonist Lixisenatide on Ischemia-Reperfusion-Induced Injury in the Isolated Rat Heart" [ABSTRACT 0968-P]. In this study the administration of lixisenatide ten minutes prior to and during reperfusion significantly reduced myocardial infarct size, and this effect is believed to be a direct cardiac effect. The second study showed "Effect of the Once-Daily GLP-1 Receptor Agonist Lixisenatide on Gastric Emptying and Prandial Carbohydrate Utilization in Animal Models: A Comparison with Liraglutide" [ABSTRACT 2267-PO]. Whether these claims will bear out in humans are yet to be seen.