Post Marketing Surveillance in Japan on Long Term Drug Use of JARDIANCE® Tablets in Patients with type 2 Diabetes Mellitus (Japanese JARDIANCE PMS, long term)

Study type

• Study topic:
  Human medicinal product

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

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

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Non-interventional, prospective, observational, single arm

Study drug and medical condition

• Name of medicine:
  JARDIANCE
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Short description of the study population:
  Male and female Japanese patients with type 2 diabetes mellitus who have never been treated with JARDIANCE® Tablets before the enrolment.
• Age groups:
  • Paediatric Population (< 18 years)

    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Type 2 diabetes mellitus patients
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  To investigate the safety and efficacy of long-term daily use of JARDIANCE® Tablets in Japanese patients with type 2 diabetes mellitus
• Outcomes:
  Incidence of adverse drug reactions, Change from baseline in HbA1c to the last- observation on treatment. Change from baseline in Fasting plasma glucose to the last- observation on treatment
• Data analysis plan:
  Descriptive statistics will be summarized for safety and efficacy. A mixed model repeated measures analysis will be performed for HbA1c over time. Incidence of adverse drug reactions Change from baseline in HbA1c to the last- observation on treatment. Change from baseline in Fasting plasma glucose to the last- observation on treatment.