Sanofi, a global healthcare leader, 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.
"This study examined an important possible use of this investigational medicine," said Richard M Bergenstal MD, executive director, International Diabetes Center at Park Nicollet, Minneapolis, Minnesota, US.
"The result highlights that this could provide a treatment option for the roughly fifty per cent 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 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.
Sanofi previously announced in July 2015 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.
Lixisenatide is a once-daily prandial glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of adult patients with type 2 diabetes mellitus. GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells.
Lixisenatide was in-licensed from Zealand Pharma A/S, and was approved in Europe in 2013 for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control. Lixisenatide is currently approved in over 60 countries worldwide for the treatment of adults with type 2 diabetes, with commercial launches in most EU countries, Japan, Brazil, Mexico and other markets. Lixisenatide is an investigational product in the US. It was resubmitted to the Food & Drug Administration (FDA) in the third quarter of 2015.