Post-authorization safety study to assess the risk of diabetic ketoacidosis among type 2 diabetes mellitus patients treated with ertugliflozin compared to patients treated with other antihyperglycemic agents (MK-8835-062)

Study type

• Study topic:
  Herbal medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  SEGLUROMET

  STEGLATRO

  STEGLUJAN
• Study drug International non-proprietary name (INN) or common name:
  ERTUGLIFLOZIN
• Anatomical Therapeutic Chemical (ATC) code:
  (A10BK04) ertugliflozin

  ertugliflozin
• Medical condition to be studied:
  Diabetic ketoacidosis

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:
  8819

Study design details

• Main study objective:
  1. To assess the risk of DKA among new users of ertugliflozin relative to new users of sulfonylureas (SUs) or thiazolidinediones (TZDs). ; 2. To assess the risk of DKA among new users of ertugliflozin relative to new users of incretin-based drugs i.e. dipeptidyl peptidase 4 (DPP-4) inhibitors or glucagon-like peptide-1 (GLP-1) receptor agonists.
• Outcomes:
  Hospitalization for DKA identified from principal discharge diagnosis of inpatient claims.
• Data analysis plan:
  Baseline demographic and clinical characteristics will be described by exposure group before and after propensity score matching. ; Incidence rates (and 95% confidence interval) of DKA will be calculated by exposure group. ; The differences between the exposure groups in terms of time to DKA will be assessed using Kaplan-Meier survival curves with log rank test. ; Cox proportional hazards models will be used separately to compare the risk of DKA among new users of ertugliflozin to that among new users of SU/TZD, and to compare the risk of DKA among new users of ertugliflozin to that among new users of incretin-based drugs. ; Subgroup analysis will be further conducted by concomitant insulin use on the index date. ; Sensitivity analyses pre-defined in the protocol will be conducted to assess the robustness of the study results.