A regulatory requirement non interventional study to monitor the safety and effectiveness of JARDIANCE® (empagliflozin 10mg, 25mg) in Korean patients with type 2 diabetes mellitus (JARDIANCE® rPMS in Korean patients with T2DM)

Study type

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

  Other
• If ‘other’, further details on the scope of the study:
  Safety monitoring

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)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  To monitor the safety profile and efficacy of JARDIANCE® (empagliflozin, 10mg, 25mg) in Korean patients with type 2 diabetes mellitus in a routine clinical practice setting
• Outcomes:
  1) PRIMARY OBJECTIVETo monitor the safety profile and effectiveness of Empagliflozin in Korea patients with type 2 diabetes mellitus in a routine clinical practice setting, 2) SECONDARY OBJECTIVE(1) Change from baseline in HbA1c after 12 weeks and/or 24 weeks of treatment(2)Occurrence of treat to target effectiveness response that is an HbA1c under treatment of < 7% after 12 weeks and/or 24 weeks of treatment(3) Occurrence of relative effectiveness response (HbA1c lowering by at least 0.5% after 12 weeks and/or 24 weeks)
• Data analysis plan:
  1)Analysis of demographic data:Demographic data and the health status of subjects for the safety evaluation will be analysed descriptively.For continuous data, mean, standard deviation, minimum value, and maximum value will be described, while for categorical data, frequency will be shown.2)Safety analysis: In the safety assessment population, the number of subjects to whom AE occurred and the number of AEs will be calculated. Also, the incidence proportion of AEs will be estimated with its 95%confidence interval.3)Efficacy analysis: Mean,standard deviation,minimum value,maximum value,and median of changes in glycosylated hemoglobin and fasting plasma glucose,body weight,and blood pressure, which were measured at the last visit versus baseline, should be presented, and if there is difference before administration versus after administration should be analyzed using paired t-test. The number and percentage of subjects for final efficacy evaluation