ARTICLE | Clinical News

Lixisenatide/insulin glargine: Additional Phase III data

July 25, 2016 7:00 AM UTC

Additional data from the open-label, international Phase III LixiLan-O trial in 1,170 Type II diabetics inadequately controlled on metformin alone or on metformin combined with a second oral anti-diabetic drug showed that once-daily subcutaneous iGlarLixi plus metformin reduced mean HbA1c from baseline to week 30, the primary endpoint, by 1.6% vs. 1.3% for once-daily subcutaneous Lantus insulin glargine plus metformin and 0.9% for once-daily subcutaneous lixisenatide plus metformin (p<0.0001 for both). Additionally, a greater proportion of patients receiving iGlarLixi plus metformin achieved an HbA1c of <7% vs. Lantus plus metformin and lixisenatide plus metformin (74% vs. 59% and 33%, respectively). iGlarLixi plus metformin also significantly reduced mean body weight by 0.3 kg vs. a 1.1 kg increase for Lantus plus metformin (p<0.0001). Data were presented at the American Diabetes Association meeting in New Orleans. Sanofi previously reported that iGlarLixi plus metformin met the primary endpoint (see BioCentury, Aug. 3, 2015). ...