Study identification

EU PAS number

EUPAS37860

Study ID

40044

Official title and acronym

Association between glucagon-like peptide 1 receptor agonist (GLP1-RA) and sodium glucose co-transporter 2 inhibitor (SGLT2i) use and COVID-19 outcomes: A national retrospective cohort study

DARWIN EU® study

No

Study countries

United States

Study description

Emerging evidence from the COVID-19 pandemic suggest that patients with type 2 diabetes comprise a significant portion of the affected population and are at higher risk for severe outcomes including hospitalization and death, yet it remains largely unknown how pre-morbid medication may impact outcomes of COVID-19 in patients with type 2 diabetes. Several medications have biologically plausible mechanisms with relevance for patients with diabetes among others including ACE inhibitors, metformin, and DPP4-inhibitors. Recent large cardiovascular outcome trials and subsequent metanalyses have demonstrated that some glucagon-like peptide-1 receptor agonists (GLP-1RA) and sodium-glucose-linked cotransporter 2 inhibitors (SGLT2i) are associated with a reduction of cardiovascular events and all-cause mortality among the same high-risk populations who show higher susceptibility to severe COVID-19 and increased mortality. Yet, no studies have examined the class effect of these newer anti-hyperglycemic of mortality and other outcomes in the setting of COVID-19 infection. These data are critical because therapeutics represent a highly actionable intervention point to improve outcomes from both the inpatient and outpatient setting for a large population of patients with inherently high risk for COVID-19 associated mortality. To address this gap and inform evolving care guidelines for patients with medication-managed type 2 diabetes during the COVID-19 pandemic, this study aims to characterize the association of use of GLP1-RA and SLGT2i with COVID-19 outcomes using real world data from the National COVID Cohort Collaborative (N3C). We will consider the well-studied and commonly used class of dipeptidyl peptidase-4 inhibitors (DPP4i) as the active comparator drug to avoid confounding by indication.

Study status

Planned
Research institutions and networks

Institutions

Networks

National COVID Cohort Collaborative (N3C)

Contact details

John Buse

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

National Institutes of Health (National Center for Advancing Translational Sciences)
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable