Safety Evaluation of Adverse Reactions in Diabetes - Drug utilisation studies (SAFEGUARD)

Study type

• Study topic:
  Disease /health condition

  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:
  Other
• Non-interventional study design, other:
  Descriptive retrospective observational study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A10) DRUGS USED IN DIABETES

  DRUGS USED IN DIABETES
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Short description of the study population:
  All patients (not just those diagnosed with T2DM) mellitus in the databases during the study period who have at least 365 consecutive days of valid data.
• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Diabetes mellitus patients
• Estimated number of subjects:
  50000000

Study design details

• Main study objective:
  To describe the use of non-insulin blood glucose lowering drugs (NIBGLD), insulins and insulin analogues at a population, patient and prescription level.
• Data analysis plan:
  The monthly incidence, prevalence and volume of exposure to different A10* coded drugs, drug classes and treatment regimens will be described. Rates of initiation, discontinuation and switching of each treatment will be calculated and patient characteristics associated with each rate will be described. Statistics describing the typical number, duration and dose of treatment episodes with each drug, drug class or treatment regimen per patient will be described. All results will be compared across age, sex and calendar year as well as across each of the participating data sources.