A regulatory requirement non interventional study to monitor the safety and effectiveness of JARDIANCE DUO® (empagliflozin/metformin, 5/500mg, 5/850mg, 5/1000mg, 12.5/500mg, 12.5/850mg, 12.5/1000mg) in Korean patients with type 2 diabetes mellitus (JARDIANCE DUO® rPMS)

Study type

• Study topic:
  Disease /health condition

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

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  JARDIANCE DUO
• Anatomical Therapeutic Chemical (ATC) code:
  (A10BD20) metformin and empagliflozin

  metformin and empagliflozin
• 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:
  600

Study design details

• Study design:
  This is a single arm study with JARDIANCE DUO®. JARDIANCE DUO® will be prescribed according to the local label and at the discretion of the treating physician. Since this is a non-interventional study, the drug will not be supplied by the sponsor.
• Main study objective:
  To monitor the safety profile and effectiveness of JARDIANCE DUO in Korean patients with type 2 diabetes mellitus in a routine clinical practice setting
• Outcomes:
  To monitor the safety profile and effectiveness of JARDIANCE DUO in Korean patients with type 2 diabetes mellitus in a routine clinical practice setting, The secondary objective of this study is to monitor the effectiveness of JARDIANCE DUO by evaluation of the change from baseline after 12 weeks and/or 24 weeks in the glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG), body weight, blood pressure (SBP, DBP) and the final effectiveness evaluation at the end of the last visit in Korean T2DM patients.
• 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 analysisAmong the subjects of safety evaluation, the number of subjects with adverse event incurred and the number of adverse events incurred should be calculated, and the incidence rate of adverse events and the 95% confidence interval should be presented.3) Effectiveness analysisMean,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.