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news.Sanofi has announced the positive results from a Phase III GetGoal Duo 1study, that will assess the efficacy and safety of lixisenatide (Lyxumia) with Lantus (insulin glargine) in patients with Type 2 diabetes.
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Lixisenatide is an investigational once-daily GLP-1 peptide agonist, found to suppress 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 demonstrated that the lixisenatide in conjugation with Lantus reduced the levelas of HbA1c with an improvement in 2-hour post-prandial glucose levels compared to insulin treatment alone in patients with Type 2 diabetes.
Lixisenatide combination therapy decreased HbA1c to a mean value of 6.96% and improved 2-hour post-prandial glucose with a mean difference of -3.16 mmol/L compared to placebo.
As per the license agreement between Sanofi and Zealand Pharma, Sanofi is developing lixisenatide both as a stand alone product in the Phase III GetGoal programme, while Zealand will get milestone payments of up to $235m and low double-digit royalties on global net sales of lixisenatide and any combination product that includes lixisenatide.
Sanofi Diabetes senior vice-president Pierre Chancel said the once-daily Lantus can be an innovative therapeutic option for the treatment of uncontrolled Type 2 diabetes regarding post-prandial glucose control, helping patients who fail to meet HbA1c target despite controlled fasting plasma glucose.
The company plans to submit for lixisenatide US regulatory approval in Q4, 2012.