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

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)

Our Standards:The Thomson Reuters Trust Principles.
0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below