Utilisation of dulaglutide in European countries: A cross-sectional, multi-country and multi-source drug utilisation study using electronic health record databases (H9X-MC-B010)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• 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:
  Cross-sectional

Study drug and medical condition

• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Short description of the study population:
  The study population included all patients receiving dulaglutide prescriptions in the outpatient setting in the selected databases of five European target countries (i.e. France, Germany, Spain, Sweden, and the UK). The eligible patients were those for whom treatment with dulaglutide was initiated during the observation period in each wave of the study for patients having at least 6 months of available continuous history prior to the date of the first dulaglutide prescription (i.e. baseline period). There were no exclusion criteria applied in this study.
• Age groups:
  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:
  Renal impaired

  Hepatic impaired

  Pregnant women
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  To describe the frequency of dulaglutide use in overall patients, and in subgroups of interest, including patients with severe renal failure, hepatic disease, heart failure, severe gastrointestinal disease, children and adolescents, elderly patients (75+ years), and pregnant and breastfeeding women. Additionally, to describe utilization in patients with medication errors and off-label use.
• Outcomes:
  To describe the frequency of off-label use among each of the subgroups of interest.
• Data analysis plan:
  Descriptive statistics will be used including univariate analysis.

Documents

Study results

B010_Final_Report_Dulaglutide_PASS_DUS_FINAL_10.28.19_Redacted