DARWIN EU® - Determinants for use of GLP1 receptor agonists – a drug utilisation study

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

  LIRAGLUTIDE

  LIXISENATIDE

  DULAGLUTIDE

  SEMAGLUTIDE

  TIRZEPATIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (A10BJ01) exenatide

  exenatide

  (A10BJ02) liraglutide

  liraglutide

  (A10BJ03) lixisenatide

  lixisenatide

  (A10BJ05) dulaglutide

  dulaglutide

  (A10BJ06) semaglutide

  semaglutide

  (A10BX16) tirzepatide

  tirzepatide

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)

Study design details

• Main study objective:
  1) To determine the incidence and prevalence of prescriptions of the GLP-1 RA ; medicines (overall, by ingredient, by pre-specified brand) during the last 10 ; years of available data, stratified separately by age, sex, indication (pre; defined presence or absence of diagnosis of type 2 diabetes mellitus and/or ; obesity) [only for incidence], and prescriber speciality (where available) [only ; for incidence], and by calendar month in each of the data sources. ; 2) To characterise new drug users of GLP-1 RA medicines (overall and stratified ; by ingredient, by brand, by indication cohorts [pre-defined presence or ; absence of diagnosis of type 2 diabetes mellitus and/or diagnosis of obesity) ; by age, sex, initial dose, cumulative dose, and a list of prespecified ; indications/comorbidities and related co-medications for each data source. ; Characterisation will be done over the whole study period and by calendar ; year. ; 3) To describe GLP-1 RA switching of substances (exenatide, liraglutide, ; lixisenatide, dulaglutide, semaglutide, or tirzepatide cohorts) among new ; GLP-1 RA users for each data source [overall study period]. ; 4) To describe GLP-1 RA within-substance switching of strength (limited to pre; defined cohorts of strength-levels, with brands when available, for liraglutide, ; dulaglutide, semaglutide, and tirzepatide) among new users of the respective ; medicine in each data source [overall study period]. ; 5) To describe GLP-1 RA switching of substances (exenatide, liraglutide, ; lixisenatide, dulaglutide, semaglutide, or tirzepatide cohorts) among new ; GLP-1 RA users for each data source between 2015–2020 and annually ; between 2021 and 2025. ; 6) To describe GLP-1 RA within-substance switching of strength (limited to pre; defined cohorts of strength-levels, with brands when available, for liraglutide, ; dulaglutide, semaglutide, and tirzepatide) among new users of the respective ; medicine in each data source between 2015–2020 and annually between ; 2021 and 2025. ;