Study type

Study topic

Disease /health condition
Human medicinal product

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 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

Main study objective

To investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese elderly 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.