Non-interventional study on the effectiveness and safety of Empagliflozin compared with DPP-4 inhibitors in patients with type 2 diabetes in the United States

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Sequential matched cohort study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  EMPAGLIFLOZIN

  SITAGLIPTIN

  SAXAGLIPTIN

  LINAGLIPTIN

  ALOGLIPTIN
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Age groups:
  • 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)
• Estimated number of subjects:
  232000

Study design details

• Main study objective:
  To compare selected CV effectiveness outcomes in patients with T2DM initiating empagliflozin compared to propensity score (PS) matched patients with T2DM initiating a DPP-4 inhibitor in sequential analyses within periodically updated cohorts in the U.S. secondary objectives include other effectiveness outcomes, safety outcomes, and healthcare utilization outcomes.
• Outcomes:
  - 3-point MACE hospital admission for MI, hospital admission for stroke, CV mortality and its individual components- hospital admission for HF- all-cause mortality, - Coronary revascularization procedure - End-stage renal disease - Initiation of laser treatment for retinopathy- Bone fracture- Diabetic ketoacidosis- Severe hypoglycemia- All urinary tract cancers and its individual components, additional cancers may be considered.- Lower-limb amputation- Acute kidney injury requiring dialysis- Healthcare resource utilization- Cost
• Data analysis plan:
  We will receive new data as they become available on a periodic basis (every 12 months) and, at each data cut, we will update the original set of data, form sequential cohorts by propensity score (PS) matching within 12-month blocks of time, follow patients for each of the outcomes of interest in a prospective manner, and estimate measures of effect using person-time based analyses among patients who initiate empagliflozin versus DPP-4 inhibitor use. Unadjusted and adjusted relative risks (hazard ratios) and rate differences will be estimated. In adjusted analyses, we will use propensity score (PS) matching to balance potential confounders.