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)

23/05/2015
18/12/2025
EU PAS number:
EUPAS9786
Study
Finalised
Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

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

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 Japanese patients with type 2 diabetes mellitus who have never been treated with JARDIANCE® Tablets before the enrolment.

Age groups

  • Adolescents (12 to < 18 years)
  • 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)

Special population of interest

Other

Special population of interest, other

Type 2 diabetes mellitus patients

Estimated number of subjects

3000
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 long-term daily use of JARDIANCE® Tablets in Japanese patients with type 2 diabetes mellitus

Setting

Sites throughout entire country were equally listed according the size of the hospitals or general clinics at which JARDIANCE® Tablets were available for prescription. Patients were selected by using the continuous
investigation system. This study was conducted in 1,103 centers in Japan. Study period: June 2015 – November 2020. Enrollment period: June 2015– May 2017

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.