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 type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A10BJ) Glucagon-like peptide-1 (GLP-1) analogues

  (A10BK) Sodium-glucose co-transporter 2 (SGLT2) inhibitors

  (A10BH) Dipeptidyl peptidase 4 (DPP-4) inhibitors
• Medical condition to be studied:
  Diabetes mellitus

  COVID-19

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  5000

Study design details

• Main study objective:
  This study aims to characterize the association of use of GLP1-RA and SLGT2i with COVID-19 outcomes among adults with diabetes and COVID-19 infection, using real world data from the National COVID Cohort Collaborative (N3C).
• Outcomes:
  The outcome is 60-day mortality following a COVID-19 diagnosis. Secondary outcomes will include markers of illness severity including hospital admission and level of respiratory support required.
• Data analysis plan:
  The aim of the analysis is to estimate the relative odds of mortality 60 days following a COVID-19 diagnosis for patients with type 2 diabetes and a history of SGLT2i/GLP1-RA use vs DPP4i use among eligible patients with COVID-19 in the N3C database. The primary estimand is the odds of mortality following 60 days from diagnosis with COVID-19. The ratio of the odds (OR) between the two drugs will be estimated using targeted maximum likelihood estimation (TMLE).