Sanofi’s 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 compared with insulin glargine 100 Units/mL alone.
“This study examined an important possible use of this investigational medicine,” said Richard M. Bergenstal MD, Executive Director, International Diabetes Centre at Park Nicollet, Minneapolis. “The result highlights that this could provide a treatment option for the roughly fifty percent of patients who are no longer able to remain at their HbA1c target, despite basal insulin treatment.”
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 in 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. Sanofi have said that full results from the study will be communicated in a future scientific forum.
LixiLan-O also met primary objective
Sanofi announced in July 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.
“The Phase III LixiLan-O and LixiLan-L clinical trials were initiated at the beginning of 2014 to explore the safety and efficacy of our investigational fixed-ratio combination when used before and after basal insulin, respectively,” said Elias Zerhouni, MD, President, Global R&D at Sanofi. “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 Q4 2015 in the United States and Q1 2016 in the European Union.
