Regulatory filings with the FDA are expected before the end of the year.
A combination of insulin glargine and the lixisenatide, a GLP-1 receptor agonist, showed superior results in helping patients with type 2 diabetes (T2D) control glycated hemoglobin (A1C) in a phase 3 trial, Sanofi reported today.
Sanofi released topline results of LixiLan-L, saying that the second pivotal trial for the drug combination met its primary endpoint. The study examined the efficacy and safety of a fixed-ratio combination of insulin glargine (Lantus), 100 units/mL, and lixisenatide versus treatment with insulin glargine 100 units/mL over a 30-week period. The study involved 736 patients with T2D whose A1C was not adequately controlled with basal insulin, either alone or in combination with 1 or 2 oral anti-diabetic agents. If patients were already taking metformin, that therapy was continued.
In July, Sanofi announced that the primary endpoint had been achieved in its first pivotal trial, LixiLan-O, which involved 1170 patients over a 30-week period. That trial involved patients whose T2D was not adequately controlled on metformin or metformin and another oral antidiabetic agent. In June, long-term cardiovascular (CV) results for lixisenatide were presented at the 75th Scientific Sessions of the American Diabetes Association, showing no CV risk or benefit.
In a statement, Sanofi said it expects to make regulatory submissions in the fourth quarter of 2015 with the FDA and in the first quarter of 2016 in Europe.