Post-authorization safety study in patients with type 2 diabetes mellitus to assess the incidence of ketoacidosis, severe complications of urinary tract infection, volume depletion, and dehydration among patients treated with EMPAGLIFLOZIN or DPP-4 inhibitors in Saudi Arabia (Post-authorization safety study in type 2 diabetic)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  JARDIANCE
• Study drug International non-proprietary name (INN) or common name:
  EMPAGLIFLOZIN
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Short description of the study population:
  Patients diagnosed with T2DM in Saudi Arabia
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
• Estimated number of subjects:
  1.500

Study design details

• Study design:
  "new users" design
• Main study objective:
  Post-authorization safety study in patients with type 2 diabetes mellitus to assess the incidence of ketoacidosis, severe complications of urinary tract infection, volume depletion, and dehydration among patients treated with EMPAGLIFLOZIN or DPP-4 inhibitors in Saudi Arabia
• Setting:
  The sites were primary care clinics, hospital clinics and other outpatient clinics. 25 sites in Saudi Arabia. The treating physicians will mainly be general practitioners (GPs) and/or specialists including endocrinologist, diabetologist & internists.
• Outcomes:
  To estimate the incidence of:- Ketoacidosis- Severe urinary tract infections- Volume depletion- Dehydrationin type 2 diabetes mellitus (T2DM) patients initiating EMPAGLIFLOZIN compared with the incidence in T2DM patients initiating Dipeptidyl peptidase-4 (DPP-4) inhibitors, To estimate the risk of each primary outcome with respect to the following definition of exposure:the Ramadan period
• Data analysis plan:
  For the incident users of EMPAGLIFLOZIN and of DPP4i, analysis will be performed using the “as-treated” (AT) approach. This corresponds to censoring individuals who discontinue use of the index drug, i.e. either switch from the index drug to any other of the index drug (EMPAGLIFLOZIN or DPP-4 inhibitor) during follow-up or stop using the index drugFor the assessment of the primary and secondary objectives, the main data analysis will be conducted in two stages: - Construction of the propensity score (PS) by modelling the exposure to EMPAGLIFLOZIN vs. DPP-4 inhibitor - Estimation of the effect of exposure to EMPAGLIFLOZIN on the ketoacidosis, severe urinary tract infections, volume depletion and dehydration compared to those exposed to DPP-4 inhibitor.