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news.A second pivotal phase III study of Sanofi's LixiLan drug has met its main target for type 2 diabetes treatment, indicating superior reduction in HbA1c compared with insulin glargine.
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The company treated 736 patients with type-2 diabetes inadequately controlled over a 30-week period. Full results of the trial will be communicated in a future scientific forum.
The efficacy and safety of the fixed-ratio combination of insulin glargine 100 Units/mL and lixisenatide was investigated with insulin glargine 100 Units/mL.
Sanofi said it had a safety profile similar to insulin glargine 100 Units/mL and lixisenatide.
Sanofi Global R&D president Elias Zerhouni said: "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.
"These studies reflect Sanofi’s commitment to developing and evaluating medicines intended to meet patient needs throughout their journey with diabetes."
Earlier this year, Sanofi said a first late-stage Phase III study of LixiLan had shown satisfactory results.
The company treated 1,170 patients over a 30 week period whose type 2 diabetes was not adequately controlled on metformin alone or on metformin combined with a second oral anti-diabetic agent.
Lixisenatide is currently approved in more than 60 countries globally to treat adults with type 2 diabetes, with commercial launches in majority of EU countries, Japan, Brazil, Mexico and others.
About 400 million people globally have diabetes, with type 2 accounting for over 90% of cases.
The number is estimated to increase in the coming years without proper treatment or changes in lifestyle.
Image: Sanofi Global R&D president Elias Zerhouni. Photo: courtesy of Sanofi.