November 29, 2016 / 6:20 PM / a year ago

BRIEF-Novo Nordisk says Tresiba demonstrates safe cardiovascular profile

Nov 29 (Reuters) - Novo Nordisk

* Says Tresiba demonstrates a safe cardiovascular profile and reduces the risk of severe hypoglycaemia compared to insulin glargine u100 in the devote trial

* Says trial achieved its primary endpoint by demonstrating non-inferiority of major adverse cardiovascular events (mace) with Tresiba compared to insulin glargine u100

* Says trial thereby confirmed results of devote interim analysis submitted to US Food and Drug Administration (FDA) in March 2015

* Says 27 pct fewer patients in Tresiba treated group experienced an episode of severe hypoglycaemia

* Says patients in Tresiba treated group experienced a 54 pct relative reduction in rate of nocturnal severe hypoglycaemia

* Says differences were all statistically significant

* Says expects to submit findings for review with regulatory authorities during first half of 2017 Source text for Eikon: Further company coverage: (Reporting by Jacob Gronholt-Pedersen. Editing by Jane Merriman)

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