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

  Safety study (incl. comparative)
• If ‘other’, further details on the scope of the study:
  Safety monitoring
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  JARDIANCE
• Study drug International non-proprietary name (INN) or common name:
  EMPAGLIFLOZIN
• Anatomical Therapeutic Chemical (ATC) code:
  (A10BK03) empagliflozin

  empagliflozin
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Short description of the study population:
  Inclusion criteria:; • Patients who have started at first time on JARDIANCE® in ; accordance with the approved label in Korea ; • Age ≥19 years at enrolment; • Patients who have signed on the data release consent form; Exclusion criteria:; • Known hypersensitivity to empagliflozin or any of its excipients; • Patients with type 1 diabetes or for the treatment of diabetic ; ketoacidosis (DKA); • Patients with persistent eGFR<60 mL/min/1.73 m2; , end stage renal ; disease or on dialysis; • Patients with rare hereditary conditions of galactose intolerance, the ; Lapp lactase deficiency or glucose-galactosemalabsorption; • Patients for whom empagliflozin is contraindicated according local ; label of JARDIANCE®
• 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

• Study design:
  This is a single arm study with JARDIANCE®. JARDIANCE® will be prescribed according to the local label and at the discretion of the treating physician.
• 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
• Setting:
  Patients will be managed according to the local practice guidelines. The choice of treatment will be solely at the discretion of the participating physician. JARDIANCE® will be administered according to the approved label in Korea.;
• 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