Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Effectiveness study (incl. comparative)
Study drug and medical condition

Name of medicine, other

JARDIANCE DUO

Medical condition to be studied

Type 2 diabetes mellitus
Population studied

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

600
Study design details

Main study objective

To monitor the safety profile and effectiveness of JARDIANCE DUO in Korean patients with type 2 diabetes mellitus in a routine clinical practice setting

Outcomes

To monitor the safety profile and effectiveness of JARDIANCE DUO in Korean patients with type 2 diabetes mellitus in a routine clinical practice setting, The secondary objective of this study is to monitor the effectiveness of JARDIANCE DUO by evaluation of the change from baseline after 12 weeks and/or 24 weeks in the glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG), body weight, blood pressure (SBP, DBP) and the final effectiveness evaluation at the end of the last visit in Korean T2DM patients.

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 analysisAmong the subjects of safety evaluation, the number of subjects with adverse event incurred and the number of adverse events incurred should be calculated, and the incidence rate of adverse events and the 95% confidence interval should be presented.3) Effectiveness analysisMean,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.