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Sanofi Reports Positive Top-Line Results in Second Pivotal LixiLan Phase III Study

LixiLan showed a superior reduction in HbA1c versus insulin glargine alone

The LixiLan-L phase III clinical trial met its primary endpoint in patients with type-2 diabetes treated with insulin glargine with or without metformin, Sanofi announced. The fixed-ratio combination of insulin glargine 100 units/mL and lixisenatide, a GLP-1 receptor agonist, demonstrated statistically superior reduction in HbA1c compared with insulin glargine 100 units/mL. Overall, the fixed-ratio combination had a safety profile reflecting the individual profiles of insulin glargine 100 units/mL and lixisenatide.

LixiLan-L investigated the efficacy and safety of the fixed-ratio combination of insulin glargine 100 units/mL and lixisenatide versus treatment with insulin glargine 100 units/mL over a 30-week period in 736 patients whose type-2 diabetes was not adequately controlled at screening on basal insulin, alone or combined with one or two oral antidiabetic agents. Treatment with metformin, if previously taken, was continued throughout the study. Full results will be communicated in a future scientific forum.

Sanofi announced in July 2015 that the LixiLan-O study met its primary objective over 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.

"The phase III LixiLan-O and LixiLan-L clinical trials were initiated at the beginning of 2014 to explore the safety and efficacy of our investigational fixed-ratio combination when used before and after basal insulin, respectively," said Elias Zerhouni, MD, President of Global R&D at Sanofi.

Regulatory submissions are planned for the fourth quarter of 2015 in the United States.

Source: Sanofi; September 14, 2015.

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