GLP-1 Lixisenatide Phase III Results

Adding lixisenatide to metformin and insulin glargine significantly reduced glycated hemoglobin levels and improved post-prandial glucose in patients with type 2 diabetes….

In the randomized, double-blind, placebo-controlled GetGoal Duo 1 study, patients uncontrolled on oral medication — mainly metformin — received either lixisenatide once-daily or placebo while insulin glargine and metformin were continued. Patients had already decreased their HbA1c — the primary efficacy endpoint — on average from 8.60% to 7.60% during a 12-week run-in period with insulin glargine.

After a 24-week randomization phase, those on lixisenatide had further significantly decreased HbA1c compared with placebo (P<0.0001) to a mean value of 6.96%, with a significantly higher percentage of patients achieving target HbA1c less than 7.0% with lixisenatide compared with placebo (56.3% versus 38.5%, respectively, P=0.0001), according to Sanofi’s press release.

Sanofi has submitted a request to the European Medicines Agency for regulatory approval and expects to submit a similar request to the FDA toward the end of 2012.

The full study results from GetGoal Duo 1 will be presented at a future medical congress, the company said.

Sanofi Press Release, Dec. 2011