A 5-year enhanced Pharmacovigilance surveillance initiative to survey and characterise spontaneous occurrence and experience of ketoacidotic events in patients treated with Empagliflozin –containing products

Study type

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

  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Enhanced Pharmacovigilance Initiative

Study drug and medical condition

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

  LINAGLIPTIN

  METFORMIN
• Anatomical Therapeutic Chemical (ATC) code:
  (A10BK) Sodium-glucose co-transporter 2 (SGLT2) inhibitors

  Sodium-glucose co-transporter 2 (SGLT2) inhibitors
• 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)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Renal impaired

  Hepatic impaired
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  To assess and characterize a potential patient population at risk for Ketoacidosis (KA), characterize the circumstances behind predisposing factors, course and treatment of KA in patients undergoing empagliflozin treatment.
• Outcomes:
  To better describe characteristics of patients developing Ketoacidosis (KA) under empagliflozin treatment, 1) To characterize potential predisposing factors in patients developing Ketoacidosis (KA) under empagliflozin treatment.2) To characterize the clinical presentation of KA in patients taking empagliflozin treatment
• Data analysis plan:
  Analyses will be based on descriptive statistics of the available sample provided by reports of Ketoacidosis (KA) and KA-related events as described above and defined by Narrow Scope KA Boehringer Ingelheim (BI) Customised Medical Dictionary for Regulatory Activities (MedDRA) Query (BIcMQ) in the BI Safety Database. The list of preferred terms will be updated with each MedDRA version update, and the final analysis will use the MedDRA version valid at the moment data collection period is finalised. An Additional sensitivity analysis based on the broad scope BIcMQ is also intended to be performed.