Sanofi (SNY) announced data demonstrating Lyxumia (lixisenatide), a once-daily investigational GLP-1 agonist, in combination with basal insulin plus oral anti-diabetic agents (OADs), significantly reduced HbA1c -- glycated hemoglobin -- in people with type 2 diabetes who were either new to insulin therapy (as early as 12 weeks after initiation) or already treated with insulin (for an average of 3.1 years).
Both GetGoal Duo 1 and GetGoal-L studies achieved the primary efficacy endpoint of HbA1c improvement with an associated significant reduction in post-prandial glucose (PPG).
GetGoal Duo 1 is a randomized, double-blind, multicenter study, assessing the efficacy and safety of lixisenatide, compared to placebo, in combination with insulin glargine and OADs (mostly metformin). During the 12-week run-in phase, 898 insulin-naïve patients were treated with insulin glargine, which was titrated to reach a target fasting plasma glucose (FPG) of 80-100 mg/dL.
The European Medicines Agency (EMA) acknowledged receipt of the Marketing Authorization Application filing for Lyxumia (lixisenatide) in November 2011. Submission for regulatory approval of lixisenatide in the U.S. is expected in the fourtj-quarter 2012.
The full study results from the GetGoal program are planned for publication in a peer-reviewed medical journal later this year.
For comments and feedback: editorial@rttnews.com