Characteristics of patients initiating empagliflozin or other non-insulin glucose lowering drugs in the United Kingdom (Empa DUS in UK)

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:
  Cross-sectional

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A10BA02) metformin

  metformin

  (A10BB) Sulfonylureas

  Sulfonylureas

  (A10BH) Dipeptidyl peptidase 4 (DPP-4) inhibitors

  Dipeptidyl peptidase 4 (DPP-4) inhibitors
• Medical condition to be studied:
  Diabetes mellitus

Population studied

• Short description of the study population:
  Individuals in the UK CPRD who have initiated empagliflozin, other SGLT-2 inhibitors, or other noninsulin GLDs (metformin, sulfonylureas, DPP-4 inhibitors, GLP-1 agonists) during the study period which will start 01 August 2014 (the empagliflozin launch date in the UK) and end 01 September 2015.
• Age groups:
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • 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:
  Other
• Special population of interest, other:
  Diabetes mellitus patients
• Estimated number of subjects:
  30.000

Study design details

• Main study objective:
  To describe and compare the general characteristics of patients with a recorded diagnosis of T2DM starting empagliflozin in the UK to the characteristics of patients with a recorded diagnosis of T2DM initiating other medications in the SGLT-2 inhibitor class and other non-insulin GLDs.
• Outcomes:
  To describe and compare the general characteristics of patients with a recorded diagnosis of T2DM starting empagliflozin in the UK to the characteristics of patients with a recorded diagnosis of T2DM initiating other non-insulin GLDs, To assess the extent of off-label use by identifying the proportion of patients initiating empagliflozin or other non-insulin GLDs who do not have a recorded diagnoisis of T2DM
• Data analysis plan:
  The analysis will be descriptive at baseline. Baseline patient characteristics will be tabulated for different exposure groups and results will be presented as means, standard deviations, medians, minimum, and maximum and interquartile range (IQR) for continuous variables, and as counts and percentages for categorical variables.