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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40044
• 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 institution and networks

Institutions

University of North Carolina at Chapel Hill

Networks

National COVID Cohort Collaborative (N3C)

Study timelines

Date when funding contract was signed

Planned: 01/06/2020

Study start date

Planned: 01/06/2020

Date of final study report

Planned: 01/04/2020

Sources of funding

Other

More details on funding

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

Study protocol

Initial protocol

N3C_DM_Meds_Covid_Outcomes_Protocol_301020_Locked

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable