Non-Interventional Study on the Side Effects of Empagliflozin Compared with DPP-4 Inhibitors in Patients with Type 2 Diabetes in New Zealand

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  EMPAGLIFLOZIN

  VILDAGLIPTIN
• Medical condition to be studied:
  Type 2 diabetes mellitus

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:
  78406

Study design details

• Main study objective:
  To compare the prevalence of side effects in patients with T2DM initiating empagliflozin compared to propensity score (PS) matched patients with T2DM initiating vildagliptin in New Zealand
• Outcomes:
  acute kidney injury, lower limp amputation, urinary tract infection, genital mycotic infection, pancreatitis, venous thromboembolism, diabetic ketoacidosis, and Fournier’s gangrene
• Data analysis plan:
  Baseline characteristics will be compared between the treatment groups. Multivariable logistic regression analysis will be performed to compare the occurrence of side effects between the two groups, adjusting for potential confounding factors. Users of empagliflozin will be matched with users of vildagliptin at a 1:1 ratio. Propensity scores will be calculated to match the confounders using the nearest neighbour method.