DARE-19 Phase III Collaboration between AstraZeneca, Saint Luke’s Mid America Heart Institute and George Clinical Shows Treatment’s Well-Established Safety Profile Was Consistent in Patients with COVID-19

OVERLAND PARK, KS, July 30 (Bernama-GLOBE NEWSWIRE) — The findings of DARE-19, a double-blind, placebo-controlled Phase III trial examining Dapagliflozin in patients with cardiometabolic risk factors hospitalized with COVID-19, have been published in The Lancet Diabetes & Endocrinology.  The study was a collaboration of  George Clinical, a global scientifically-backed clinical research organization and Saint Luke’s Mid America Heart Institute and was funded by AstraZeneca.

Prior to the study, it was established that patients hospitalized with COVID-19 with cardiometabolic risk factors had an elevated risk of organ failure and death.  DARE-19 was the first large, randomized controlled study of hospitalized patients with COVID-19 to evaluate the safety and efficacy of SGLT2 inhibitors.  Detailed results from the primary analysis of the DARE-19 Phase III trial assessing the potential of Farxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, to treat patients hospitalized with COVID-19 who are at risk of developing serious complications, showed that the trial did not achieve statistical significance for the two primary endpoints. However, there were numerically fewer events of death or new or worsened organ dysfunction in the Farxiga group compared with placebo.

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