Therapy Areas: Diabetes
DARE-19 Trial Finds Dapagliflozin Well Tolerated in Hospitalized COVID-19 Patients
28 June 2021 - - Results from the DARE-19 clinical trial showed that SGLT2 inhibitor Dapagliflozin was well tolerated in hospitalized COVID-19 patients, the American Diabetes Association said.

DARE-19 is the first large randomized clinical trial to assess sodium-glucose cotransporter-2 (SGLT2) inhibitors in patients with and without type 2 diabetes hospitalized with COVID-19.

Expanded results from the first-of-its-kind clinical trial explored the use of SGLT2 inhibitor for COVID-19 patients with hypertension, cardiovascular disease, heart failure, type 2 diabetes, or chronic kidney disease.

Additional findings from the trial were presented at the virtual 81st Scientific Sessions of the American Diabetes Association (ADA).

Patients with cardiometabolic risk factors, including type 2 diabetes, are at higher risk for developing serious COVID-19 related complications such as organ failure and death.

In fact, Americans with diabetes and other related underlying health conditions are hospitalized six times more often and are 12 times more likely to die of COVID-19 than those without.

Previous studies have shown SGLT2 inhibitors, a medication class initially used to help lower blood glucose, provide organ protection in patients with type 2 diabetes, heart failure, and chronic kidney disease.

DARE-19, an investigator-sponsored, international, randomized trial, compared SGLT2 inhibitor dapagliflozin to placebo in 1,250 patients hospitalized for COVID-19 who also had a history of hypertension, atherosclerotic cardiovascular disease, heart failure with either preserved or reduced ejection fraction, type 2 diabetes, or stage three to four chronic kidney disease with estimated glomerular filtration rate between 25 and 60.

Patients were recruited across 95 centers in seven countries between April 2020 and January 2021. Approximately half of the patients had a history of type 2 diabetes. Patients received dapagliflozin or placebo for 30 days in addition to the standard of care for COVID-19 in the participating hospital.

Results of the trial indicated that treatment with dapagliflozin did not achieve statistically significant reduction in organ failure or death, or significantly improve clinical recovery, as compared with placebo (the two primary endpoints).

Numerically fewer patients treated with dapagliflozin experienced organ failure or death (11.2% versus 13.8% with placebo, respectively), although this difference was not statistically significant.

The findings were consistent across components of this endpoint (respiratory, cardiovascular, kidney complications, or death from any cause). These results were also consistent in patients both with and without type 2 diabetes.

Dapagliflozin was well tolerated, with numerically fewer serious adverse events than placebo, and these findings were also consistent in patients with and without type 2 diabetes.

Only two non-severe events of DKA were reported (both in patients with Type 2 diabetes).

Furthermore, laboratory parameters were stable during hospitalization in patients treated with dapagliflozin and placebo, regardless of diabetes status.

The authors state that future trials are needed to further evaluate possible effects of dapagliflozin on the risk of organ failure or death in patients hospitalized with COVID-19.

They also note DARE-19, which was funded by AstraZeneca, has important implications for future research, as it raises a hypothesis that SGLT2 inhibitors may offer organ protection in other types of acute illness such as sepsis, which should be explored in future studies.