Sanofi, a global healthcare leader, announced that the LixiLan-O phase III clinical trial met its primary objective in patients with type 2 diabetes treated with metformin.

The fixed-ratio combination of insulin glargine 100 units/ml and lixisenatide, a GLP-1 RA, demonstrated statistically superior reduction in HbA1c (average blood glucose over the previous three months) compared with lixisenatide and compared with insulin glargine 100 units/ml. Overall, the fixed-ratio combination had a safety profile reflecting those of lixisenatide and insulin glargine 100 units/ml.

"Meeting the primary objective of this important phase III study highlights the potential clinical value of this investigational therapeutic option," said Dr. Elias Zerhouni, president, global R&D at Sanofi.

"We look forward to advancing the LixiLan programme and bringing this combination of insulin glargine and lixisenatide to patients."

The phase III LixiLan clinical development programme began in Q1 2014 and consists of the LixiLan-O and LixiLan-L trials. LixiLan-O investigated the efficacy and safety of a once-daily single injection of the fixed-ratio combination of insulin glargine 100 units/ml and lixisenatide versus treatment with either lixisenatide or insulin glargine 100 units/ml 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. Treatment with metformin was continued for all participants throughout the study. Full results will be communicated in an appropriate scientific forum.

The ongoing LixiLan-L study investigates the efficacy and safety of a once-daily single injection 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 a basal insulin with or without oral anti-diabetic drugs. Only metformin, if taken, was continued throughout the study. The study will be completed in Q3 2015.

Following an analysis of results from both phase III studies, LixiLan-O and LixiLan-L, Sanofi will determine the next steps in the regulatory process. Currently, regulatory submissions are planned for Q4 2015 in the United States and Q1 2016 in the European Union.

Prescription Lantus is a long-acting insulin used to treat adults with type 2 diabetes and adults and pediatric patients (children 6 years and older) with type 1 diabetes for the control of high blood sugar. It should be taken once a day at the same time each day to lower blood glucose. Lantus SoloSTAR is a disposable prefilled insulin pen.

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 50 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 will be resubmitted to the Food & Drug Administration (FDA) in the third quarter of 2015.