Empagliflozin vs. DPP-4 inhibitors and GLP-1 Receptor Agonists Cost of Care Study: a German claims data analysis

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other

  Drug utilisation
• If ‘other’, further details on the scope of the study:
  Comparative cost evaluation

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  EMPAGLIFLOZIN
• Anatomical Therapeutic Chemical (ATC) code:
  (A10BH) Dipeptidyl peptidase 4 (DPP-4) inhibitors

  Dipeptidyl peptidase 4 (DPP-4) inhibitors

  (A10BJ) Glucagon-like peptide-1 (GLP-1) analogues

  Glucagon-like peptide-1 (GLP-1) analogues
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  25000

Study design details

• Main study objective:
  Comparison of direct and indirect healthcare cost of T2D patients treated with Empagliflozin vs. DPP-4i or GLP-1-RA
• Outcomes:
  Total direct healthcare cost of T2D patients treated with Empagliflozin vs. DPP-4i or GLP-1-RA, - Direct healthcare cost segments (hospital cost, outpatient cost, drug cost, remedies and aids cost) of T2D patients treated with Empagliflozin vs. DPP-4i or GLP-1-RA- Indirect healthcare cost of T2D patients treated with Empagliflozin vs. DPP-4i or GLP-1-RA
• Data analysis plan:
  Before a comparison will be done, a propensity score matching (PSM) will be performed, to control for potential differences of baseline characteristics between the patients. In that PSM, all available baseline characteristics will be initially included (logistic regression that predicts belonging to one of the two compared cohorts). In a stepwise exclusion procedure, only those which influence significantly the probability to belong to one of the pre-defined groups will remain in the model . Finally, PS-matched samples will be compared.