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
• Medical condition to be studied:
  Diabetic ketoacidosis

Population studied

• Age groups:
  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)
• 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.

Documents

Study report

MK-8835-06-interim-report-dec-2021_final redaction

MK-8835-062-02-interim-report-dec-2022_final redaction

MK-8835-062-second-interim-report-nov-2022_final redaction

p62mk8835-final-study-report-AUG-2024_final-redaction.pdf

Study, other information

MK-8835-062-02-interim-report-dec-2022_final redaction.pdf

MK-8835-062-second-interim-report-nov-2022_final redaction.pdf