Positive results announced in two diabetes Phase III studies

Sanofi recently announced the results of the Phase III LixiLan-O and LixiLan-L clinical trials, which compared the titratable fixed-ratio combination versus basal insulin glargine and lixisenatide.

Top-line results of the studies were presented in 2015. Attendees of the American Diabetes Association 76th Scientific Sessions saw the full results of the clinical trials on June 12. Both study results have been submitted to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).

"These studies reflect Sanofi's commitment to innovative approaches in developing medicines intended to help patients meet their needs throughout their diabetes journey," Sanofi SVP, Global Head of Development, Dr. Jorge Insuasty said. "We look forward to continuing to work with the FDA and EMA as they complete their reviews and to receiving their decisions."

The studies compared the titratable fixed-ratio combination of insulin glargine and lixisenatide versus treatment with the individual medications. Participants in the studies were type 2 diabetics. The LixiLan-O study enrolled 1,170 participants who were treated with the combination medication, insulin glargine or lixisenatide. The LixiLan-L study included 736 participants who were treated with the combination medication or insulin glargine. The 30-week studies compared the safety and efficiency of the various treatments.


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