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Positive Results Reported for Insulin Glargine/Lixisenatide Combo in Phase III Trial

FDA submission planned for late 2015

A fixed-ratio combination of insulin glargine and lixisenatide (a glucagon-like peptide-1 [GLP-1] receptor agonist) has demonstrated a statistically superior reduction in hemoglobin A1c (the average blood glucose over the previous 3 months) compared with lixisenatide alone and with insulin glargine alone in patients with type-2 diabetes treated with metformin. The combination therapy was developed by Sanofi.

The phase III LixiLan clinical development program began in the first quarter of 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 U/mL and lixisenatide compared with either lixisenatide or insulin glargine 100 U/mL during 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 antidiabetic agent. Treatment with metformin was continued for all participants throughout the study.

The ongoing LixiLan-L study is investigating the efficacy and safety of a once-daily single injection of the fixed-ratio combination of insulin glargine 100 U/mL and lixisenatide compared with insulin glargine 100 U/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 antidiabetic drugs. Only metformin, if taken, was continued throughout the study, which will be completed in the third quarter of 2015.

After analyzing the results from the LixiLan-O and LixiLan-L trials, Sanofi will determine the next steps in the regulatory process. Currently, submission to the FDA is planned for the fourth quarter of 2015.

Source: Sanofi; July 29, 2015.

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