JARDIANCE Regulartory Post Marketing Surveillance in Korean Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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To monitor the safety profile and effectiveness of Empagliflozin in Korea patients with type 2 diabetes mellitus in a routine clinical practice setting

Official Title
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A Regulatory Requirement Non Interventional Study to Monitor the Safety and Effectiveness of JARDIANCE® (Empagliflozin, 10mg, 25mg, q.d.) in Korean Patients With Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: JARDIANCE 10mg
* Drug: JARDIANCE 25mg


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients who have been started on JARDIANCE® in accordance with the approved label in Korea Age = 19 years at enrolment Patients who have signed on the data release consent form Exclusion criteria: Known hypersensitivity to empagliflozin or any of its excipients Patients with type 1 diabetes or for the treatment of diabetic ketoacidosis Patients with persistent estimated Glomerular Filtration Rate <60 mL/min/1.73 m2,end stage renal disease or on dialysis Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption Patients for whom empagliflozin is contraindicated according local label of JARDIANCE®

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| JARDIANCE<br>T2DM with JARDIANCE | Drug: JARDIANCE 10mg<br>* T2DM with JARDIANCE 10mg<br>Drug: JARDIANCE 25mg<br>* MT2DM with JARDIANCE 25mgax<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Any Adverse Events | Percentage of participants with any adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method. | From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days. | 
| Percentage of Participants With Adverse Events Relating to Study Drug | Percentage of participants with adverse events relating to study drug was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method. | From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days. | 
| Percentage of Participants With Unexpected Adverse Events | Percentage of participants with unexpected adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method. | From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days. | 
| Percentage of Participants With Adverse Events of Special Interest | Percentage of participants with adverse events of special interest (AESI) was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method. The following are considered as AESIs: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection Increased urination Urinary tract infection (UTI) Volume depletion Diabetic Ketoacidosis (DKA) Decreased renal function: Hepatic injury Lower limb amputation | From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days. | 
| Percentage of Participants With Adverse Events Leading to Discontinuation of the Drug | Percentage of participants with adverse events leading to discontinuation of the drug was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method. | From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Last Visit | Change from baseline in glycosylated hemoglobin (HbA1c) at last visit. | At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544). | 
| Number of Patients Who Had Glycosylated Hemoglobin (HbA1c) Reaching Less Than 7% (Target Efficacy Response Rate) at the Last Visit | Number of patients who had glycosylated hemoglobin (HbA1c) reaching less than 7% (target efficacy response rate) at the last visit. | At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544). | 
| Number of Patients With Relative Effectiveness Response in Glycosylated Hemoglobin (HbA1c) (Decrease by at Least 0.5% Comparing to Baseline) at the Last Visit | Number of patients with relative effectiveness response in glycosylated hemoglobin (HbA1c) (decrease by at least 0.5% comparing to baseline) at the last visit | At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544). | 
| Change From Baseline in Fasting Plasma Glucose (FPG) at Last Visit | Change from baseline in fasting plasma glucose (FPG) at last visit. | At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544). | 
| Change From Baseline in Body Weight at Last Visit | Change from baseline in body weight at last visit. | At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544). | 
| Change From Baseline in Systolic Blood Pressure (SBP) at Last Visit | Change from baseline in systolic blood pressure (SBP) at last visit. | At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544). | 
| Change From Baseline in Diastolic Blood Pressure (DBP) at Last Visit | Change from baseline in diastolic blood pressure (DBP) at last visit. | At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544). | 
| Number of Participants Per Final Effectiveness Assessment Category at Last Visit | Number of participants per final effectiveness assessment category at last visit was reported. The final effeciveness consisted of 4 categories: Improved (If determined as there was any effect of maintaining or improving disease related factors.), Unchanged (If disease related factors had not been changed compared with before administration, and not determined as there was any effect of maintaining symptoms.), Aggravated (If disease related factors were worse than before administration.), and Unassessable (If it cannot be determined due to insufficient information collected.). | At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544). |