Sanofi reports positive data from new diabetes drug trial

Sanofi has announced positive top-line results from a phase III trial assessing the safety and efficacy of a new combination therapy for type 2 diabetes.

Data from the LixiLan-L study showed that the fixed-ratio combination of insulin glargine 100 units/mL and lixisenatide demonstrated statistically superior reduction in blood glucose levels compared with insulin glargine alone.

The regimen was able to meet its primary endpoint in patients with type 2 diabetes treated with insulin glargine with or without metformin. Additionally, the fixed-ratio combination had a safety profile reflecting those of insulin glargine 100 Units/mL and lixisenatide.

This comes after data from the LixiLan-O study, reported in July, showed the therapy's effectiveness over a 30-week period in 1,170 patients whose type 2 diabetes was not adequately controlled with metformin.

Dr Elias Zerhouni, president of global research and development at Sanofi, said: "These studies reflect Sanofi's commitment to developing and evaluating medicines intended to meet patient needs throughout their journey with diabetes."

Regulatory submissions are planned for the new therapy in Q4 2015 in the US and Q1 2016 in the EU.