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Sanofi Reports Positive Results for Diabetes Treatment, Report
Sanofi Reports Positive Results for Diabetes Treatment, Report

Sanofi Reports Positive Results for Diabetes Treatment, Report

Sanofi’s combination diabetes drug hits goal in second late-stage trial.

Sanofi announced today that 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. The fixed-ratio combination of insulin glargine 100 Units/mL and lixisenatide, a GLP-1 receptor agonist, demonstrated statistically superior reduction in HbA1c (average blood glucose over the previous three months) compared with insulin glargine 100 Units/mL. Overall, the fixed-ratio combination had a safety profile reflecting those of insulin glargine 100 Units/mL and lixisenatide.

“This study examined an important possible use of this investigational medicine,” said Richard M Bergenstal MD, Executive Director, International Diabetes Center at Park Nicollet, Minneapolis, Minn., U.S. “The result highlights that this could provide a treatment option for the roughly fifty percent of patients who are no longer able to remain at their HbA1c target, despite basal insulin treatment.”

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 to two oral anti-diabetic agents. Treatment with metformin, if previously taken, was continued throughout the study. Full results will be communicated in a future scientific forum.

Sanofi previously 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 anti-diabetic 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, Global R&D at Sanofi. “These studies reflect Sanofi’s commitment to developing and evaluating medicines intended to meet patient needs throughout their journey with diabetes.”

Agencies/Canadajorunal/Press Releases




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