Sanofi’s combination type 2 diabetes drug LixiLan has met its primary endpoint in its first Phase III trial.
The drug combines Sanofi’s Lantus (insulin glargine) with Lyxumia (lixisenatide), a glucagon-like peptide-1 (GLP-1) receptor agonist co-developed with the Danish firm Zealand Pharma. GLP-1 is released within minutes after eating a meal and is known to stimulate glucose-dependent insulin secretion.
In the LixiLan-O study, the combination demonstrated superior reduction in average blood sugar compared with either drug alone.
Sanofi is awaiting results from the second Phase III trial, LixiLan-L, before deciding the next steps for the drug – but says that regulatory submissions are planned for Q4 2015 in the US and Q1 2016 in the EU.
It will not be the first insulin and GLP-1 combo on the market, though. Novo Nordisk’s Xultophy, which combines Long-acting basal insulin Tresiba with blockbuster GLP-1 receptor agonist Victoza (liraglutide), launched in the UK in June.