Impact of use of newer glucose lowering drugs on outcomes in patients with COVID-19

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

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

  Glucagon-like peptide-1 (GLP-1) analogues

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

  Sodium-glucose co-transporter 2 (SGLT2) inhibitors

  (A10BH) Dipeptidyl peptidase 4 (DPP-4) inhibitors

  Dipeptidyl peptidase 4 (DPP-4) inhibitors
• Medical condition to be studied:
  COVID-19

  Suspected COVID-19

Population studied

• Short description of the study population:
  The study population consists of all patients tested positive for SARS-CoV-2 in Denmark who have had permanent residence in Denmark for at least the past year.
• Age groups:
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • 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)
• Special population of interest:
  Other
• Special population of interest, other:
  COVID-19 patients
• Estimated number of subjects:
  10000

Study design details

• Main study objective:
  The main objective of the study is to examine the association between ongoing use of newer glucose-lowering drugs (DPP4i, SGLT2i, and GLP-1 receptor agonists) and other glucose lowering drugs and risk of severe outcomes in COVID-19 patients.
• Outcomes:
  The primary outcome is death within 30 days after positive SARS-CoV-2 test. The secondary outcomes include hospital admission, intensive care unit (ICU) admission and mechanical ventilation within 30 days after positive SARS-CoV-2 test.
• Data analysis plan:
  We will estimate risk ratios for hospital admission, ICU admission, mechanical ventilation and death in patients tested positive for SARS-CoV-2 for the exposed group (current use of GLP-1 receptor agonists) vs. the active comparator group (current use of SGLT2 inhibitors) by log binomial regression. We will apply propensity score matching and inverse probability of treatment weighting to adjust for pre-existing differences in significant risk factors between the exposed and active comparator group. Patients will be matched 1:1, unless other matching sets are possible. Covariates include diabetes duration, use of other glucose lowering drugs, diabetic complications, cardiovascular disease, total burden of comorbidities, markers of tobacco smoking, alcoholism, medical obesty and socioeconomic markers. In secondary analyses, we will study patients with current use of DPP-4 inhibitors compared to the active comparator group (i.e. patients with current use of SGLT2 inhibitors).