Trial of Lyxumia (lixisenatide) meets endpoints in Type 2 Diabetes- Sanofi

Sanofi announced that Lyxumia (lixisenatide) met all co-primary endpoints in a clinical trial (GetGoal Duo-2) comparing its use as a once-daily add-on to basal insulin versus the addition of rapid acting insulin injected once each day at main meal (basal-plus) or three times daily at each meal (basal-bolus), in adults with type 2 diabetes poorly controlled on basal insulin.

Lixisenatide was shown to be non-inferior to both comparator insulin regimens for reduction in blood sugar (HbA1c) and statistically superior to basal-bolus for body weight change, as co-primary endpoints for the study. The study also showed that documented hypoglycemia was numerically lower in the lixisenatide group versus the group receiving rapid acting insulin once each day and significantly lower versus the group receiving rapid acting insulin three times each day.

Comment: The data will be included in the New Drug Application for lixisenatide, which is on track to be resubmitted to the FDA in the third-quarter of 2015. The original application was withdrawn in 2013 following discussions with the FDA regarding its proposed process for the review of interim data.