New combination drug LixiLan succeeds in phase III trial

A new combination drug for type 2 diabetes, LixiLan has demonstrated positive results in its second phase III clinical trial.
The drug is a combination of the GLP-1 receptor agonist, Lyxumia (lixisenatide), with the long acting analogue insulin, Lantus (insulin glargine). LixiLan has been developed by Sanofi and also includes development from Danish pharmaceutical firm Zealand which were involved in Lyxumia.
The LixiLan-L trial was a 30 week trial of the drug in 736 patients with type 2 diabetes that did not have their diabetes under adequate controlled under basal insulin, with or without additional oral drugs. Not under control was defined as an HbA1c between 59 and 86 mmol/mol (7.5 and 10%).
The results showed that participants taking LixiLan had a stronger improvement in HbA1c than the patients that took Lantus (insulin glargine).
The LixiLan-L trial follows a previous trial, the LixiLan-O trial, which also showed that LixiLan could significantly reduce HbA1c over a 30 week period.
Zealand announce that LixiLan is on track to be submitted to the US Food and Drug Administration (FDA) in Q4 of 2015 and to European Medicines Agency (EMA) in Q1 of 2016. If approved by the EMA, LixiLan could be available on the NHS in 2016.
If approved, LixiLan would represent an alternative long acting insulin and GLP-1 recepter agonist combination drug to Novo Nordisk’s Xultophy. Xultophy is a combination of Victoza (liraglutide) and Tresiba (insulin degludec) and was launched in the UK in November 2014.