Zealand Pharma A/S' Partner Sanofi SA Announces Lyxumia (lixisenatide) in Combination with Basal Insulin plus Oral Anti-Diabetics Significantly Reduces HbA1c and Post-Prandial Glucose-COMPLETE STORY

Zealand Pharma A/S announced that its partner Sanofi SA announced data demonstrating that Lyxumia (lixisenatide), a once-daily investigational GLP-1 agonist, in combination with basal insulin plus oral anti-diabetic agents (OADs), significantly reduced HbA1c - glycated hemoglobin - in people with type 2 diabetes who were either new to insulin therapy (as early as 12 weeks after initiation) or already treated with insulin (for an average of 3.1 years). Both GetGoal Duo 1 and GetGoal-L studies achieved the primary efficacy endpoint of HbA1c improvement with an associated significant reduction in post-prandial glucose (PPG). During the 12-week run-in phase, 898 insulin-naive patients were treated with insulin glargine, which was titrated to reach a target fasting plasma glucose (FPG) of 80-100 mg/dL. After the run-in phase, 446 patients with HbA1c >7% (despite controlled FPG levels) received either once-daily lixisenatide 20 microgram or placebo for 24 weeks while metformin and insulin glargine titration were continued. HbA1c decreased on average from 8.60% to 7.60% during the run-in period with insulin glargine. The addition of lixisenatide led to a further significant HbA1c decrease to a mean value of 6.96% after 24 weeks compared to 7.3% in patients receiving placebo (p<0.0001). A significantly higher percentage of patients achieved target HbA1c <7.0% with lixisenatide compared to placebo (56.3% vs. 38.5%, respectively, p=0.0001).