UPDATE: Sanofi's late-stage drug trial for type 2 diabetes meets primary endpoint

29 July 2015

French drug major Sanofi (Euronext: SAN) on Wednesday said the LixiLan-O Phase III trial for its drug candidate to treat type 2 diabetes has met its primary endpoint.

The company said 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 (Lantus) 100 units/ml and lixisenatide versus treatment with either lixisenatide or insulin glargine 100 units/ml 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 study will be completed in Q3 2015.

Sanofi plans to make submissions for US regulatory approvals by the fourth quarter of this year and in the European Union by the first quarter of 2016.

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