Sanofi-aventis has presented the positive top-line results from a Phase III study, GetGoal Duo 1, designed to investigate the efficacy and safety of lixisenatide (Lyxumia) in combination with Lantus (insulin glargine), for the treatment of patients with type 2 diabetes.
Developed by Zealand Pharma, Lixisenatide is an investigational once-daily GLP-1 peptide agonist, known to inhibit glucagon secretion from pancreatic alpha cells and enhance insulin secretion by pancreatic beta cells.
The 24-week randomised double-blind placebo-controlled Phase III GetGoal Duo 1 study showed that the lixisenatide in combination with Lantus attained the primary study endpoint of reducing HbA1c with a considerable improvement in 2-hour post-prandial glucose levels compared to insulin treatment alone in patients with type 2 diabetes.
The study also demonstrated that treatment with lixisenatide and Lantus decreased HbA1c after 24 weeks to a mean value of 6.96% and improved two-hour post-prandial glucose with a mean difference of -3.16mmol/L compared to placebo.
Zealand Pharma president and CEO David Solomon said the positive data from the GetGoal Duo 1 study supports the use of lixisenatide with Lantus for the treatment of type 2 diabetes.
''Lantus is the number-one leading basal insulin product in the world, and the results from GetGoal Duo 1 show that adding lixisenatide to treatment with Lantus can offer significant benefits to patients," Solomon added.
Sanofi diabetes senior vice-president Pierre Chancel said the once-daily Lantus combination therapy could be an innovative therapeutic option for the treatment of uncontrolled type 2 diabetes with respect to post-prandial glucose control, while helping those patients who fail to meet HbA1c target despite controlled fasting plasma glucose.
Oregon Health and Science University, Portland, US Diabetes Division head Matthew Riddle said the once-daily Lantus improved HbA1c with beneficial effects on both post-prandial glucose and body weight.
As per the licence agreement between Sanofi and Zealand Pharma, Sanofi is developing lixisenatide as a stand-alone product in the Phase III GetGoal programme, and Zealand will receive remaining milestone payments of up to $235m and low double-digit royalties on global net sales of lixisenatide and any combination product that includes lixisenatide.
The European Medicines Agency (EMA) has accepted Sanofi's marketing authorisation application for lixisenatide, and US regulatory approval submission of lixisenatide is expected in Q4 2012.