LixiLan (insulin glargine plus lixisenatide) success in Phase IIILixiLan-O study for type 2 diabetes- Sanofi

Sanofi announced that the LixiLan-L Phase III clinical trial met its primary endpoint in patients with type 2 diabetes treated with insulin glargine with or without metformin. 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. Overall, the fixed-ratio combination had a safety profile reflecting those of insulin glargine 100 Units/mL and lixisenatide. LixiLan-L investigated the efficacy and safety of the fixed-ratio combination of insulin glargine 100 Units/mL and lixisenatide versus treatment with insulin glargine 100 Units/mL over a 30 week period in 736 patients whose type 2 diabetes was not adequately controlled at screening on basal insulin, alone or combined with one to two oral anti-diabetic agents. Treatment with metformin, if previously taken, was continued throughout the study. Full results will be communicated in a future scientific forum.

Comment:Sanofi previously announced that the LixiLan-O study met its primary objective over a 30 week period in 1,170 patients whose type 2 diabetes was not adequately controlled on metformin alone or on metformin combined with a second oral anti-diabetic agent.

Comment:> Regulatory submissions are planned for Q4 2015 in the United States and Q1 2016 in the European Union.

Comment: With Lantus (insuulin glargine)already facing biosimilar competition, LixiLan is seen as a key product for Sanofi to support its basal insulin franchise. If approved LixiLan will compete in the market with Novo Nordisk's insulin/GLP-1 agonist product Xultophy (insulin degludec/liraglutide), which was launched earlier this year.