Diabetes combination drug LixiLan hits goal in second late-stage trial

On Monday, Sanofi said a second late-stage Phase III study of its LixiLan diabetes drug had met its key target. This success has made it all set for regulatory submissions by the fourth quarter in the United States and the first quarter of next year in the European Union.

LixiLan includes a single-injection combination of Lyxumia, a drug developed with Danish drugmaker Zealand Pharma, and Sanofi's Lantus. It is aimed at patients with type-2 diabetes.

In a statement, the French drugmaker said the full results will be communicated in a future scientific forum.

The French drugmaker said that the LixiLan-L Phase III clinical trial has achieved its primary endpoint in patients with type 2 diabetes, who went under treatment with insulin glargine with or without metformin.

It said, “The fixed-ratio combination of insulin glargine 100 Units/mL and lixisenatide, a GLP-1 receptor agonist, demonstrated statistically superior reduction in HbA1c (average blood glucose over the previous three months) compared with insulin glargine 100 Units/mL”. Sanofi said in July that a first late-stage Phase III study of LixiLan had come up with satisfactory results.

In the world, there are around 400 million people, who have diabetes, with type 2 accounting for over 90% of cases. If proper treatment is not given or no changes are brought in lifestyle, then those numbers are likely to grow substantially in the approaching years.