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 type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  JARDIANCE
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)
• Estimated number of subjects:
  1500

Study design details

• 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
• 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.