Sanofis type 2 diabetes drug LixiLan meets target in Phase III trial

French pharmaceutical company Sanofi have announced successful results from its first Phase III trial of type 2 diabetes drug LixiLan.
LixiLa, which was developed with Zealand Pharma, is a GLP-1/basal insulin combination. It consists of a single-injection of Lyxumia (lixisenatide), developed by Zealand, and Lantus (glargine), which is made by Sanofi.
Two Phase III trials have been conducted on LixiLa, but the LixiLan-O trial is the first to have been successfully completed. In this study, 1,170 patients with type 2 diabetes were recruited.
All of the participants had insufficiently controlled blood glucose on either metformin alone, or metformin with a second anti-diabetic agent. They were randomised to 30 weeks of treatment with LixiLa, Lyuxmia or Lantus, while still being treated with metformin.
LixiLan showed a statistically superior reduction in HbA1c levels compared with Lyxumia only, and Lantus only, Sanofi reported.
Zealand President and CEO, Britt Meelby Jense, said: “These first Phase III conclusions confirm the therapeutic relevance of LixiLan and support the product’s potential as a new single-injection combination treatment for patients with type 2 diabetes.”
A second study known as LixiLan-L is currently investigating LixiLan on type 2 patients whose blood glucose levels are not adequately controlled on Lantus alone. Sanofi hopes to have results from the trial later this year.
When all results from the Phase III trials have been analysed, Sanofi is planning regulatory submissions to be made in the United States and the European Union to get LixiLan to market.