Post Marketing Surveillance in Japan on Drug Use of JARDIANCE® Tablets in Elderly Patients with type 2 Diabetes Mellitus (Japanese PMS, elderly patients)

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

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

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:
  Male and female elderly patients (age 65 and over) with type 2 diabetes mellitus who have never been treated with JARDIANCE® Tablets before the enrolment and start taking JARDIANCE® Tablets within 3 months after launch in Japan.
• Age groups:
  • 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:
  Diabetes mellitus patients
• Estimated number of subjects:
  720

Study design details

• Study design:
  Cohort study. Non-interventional, prospective, observational, single arm based on new ; data collection
• Main study objective:
  To investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese elderly patients with type 2 diabetes mellitus.
• Setting:
  All elderly patients at the sites making contracts were registered during the ; enrolment period (3 months after launch). The patients’ data were; collected retrospectively since the date of contract.; This study was conducted in 114 centers in Japan. ; Study period: February 2015 – September 2016 ; Enrolment period: February 2015 – May 2015
• 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.