Esgliteo Post Marketing Surveillance (PMS) in Korean Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to monitor the safety and effectiveness of Esgliteo in Korean patients with type 2 diabetes mellitus in a routine clinical practice setting.

Official Title
-----------------
A Regulatory Requirement Non-interventional Study to Monitor the Safety and Effectiveness of Esgliteo (Empagliflozin/Linagliptin, 10/5mg, 25/5mg) in Korean Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: empagliflozin/linagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have started at first time on Esgliteo 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: Patients with previous exposure to Esgliteo Patients with hypersensitivity to the empagliflozin and/or linagliptin or any of the excipients Patients with type 1 diabetes or diabetic ketoacidosis Patients with estimated Glomerular Filtration Rate (eGFR) < 45 mL/min/1.73m2, end stage renal disease, or patient on dialysis Patients for whom empagliflozin/linagliptin is contraindicated according to the local label of Esgliteo

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients diagnosed with type 2 diabetes mellitus<br> | Drug: empagliflozin/linagliptin<br>* tablet<br>* Other names: Esgliteo®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of adverse events | Adverse events - including unexpected adverse events, serious adverse events, drug-related adverse events, non-serious adverse drug reactions, adverse events of special interest, adverse events leading to discontinuation, adverse events by intensity/outcome of the events/causality) | up to 24 weeks | 
| Change from baseline in HbA1c after 12 weeks of treatment |  | at baseline, at week 12 | 
| Change from baseline in HbA1c after 24 weeks of treatment |  | at baseline, at week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of treat to target effectiveness response after 12 weeks | effectiveness response is an Glucosylated Hemoglobin (HbA1c) under treatment of < 7% | at week 12 | 
| Occurrence of treat to target effectiveness response after 24 weeks | effectiveness response is an Glucosylated Hemoglobin (HbA1c) under treatment of < 7% | at week 24 | 
| Occurrence of relative effectiveness response after 12 weeks | relative effectiveness response is HbA1c lowering by at least 0.5% | at week 12 | 
| Occurrence of relative effectiveness response after 24 weeks | relative effectiveness response is HbA1c lowering by at least 0.5% | at week 24 | 
| Change from baseline in fasting plasma glucose (FPG) after 12 weeks of treatment |  | at baseline, at week 12 | 
| Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment |  | at baseline, at week 24 | 
| Change from baseline in body weight after 12 weeks weeks of treatment |  | at baseline, at week 12 | 
| Change from baseline in body weight after 24 weeks weeks of treatment |  | at baseline, at week 24 | 
| Change from baseline in systolic blood pressure after 12 weeks of treatment |  | at baseline, at week 12 | 
| Change from baseline in diastolic blood pressure after 12 weeks of treatment |  | at baseline, at week 12 | 
| Change from baseline in systolic blood pressure after 24 weeks of treatment |  | at baseline, at week 24 | 
| Change from baseline in diastolic blood pressure after 24 weeks of treatment |  | at baseline, at week 24 | 
| Number of Participants with Final effectiveness evaluation | Final effectiveness will be evaluated as 'improved', 'unchanged', 'aggravated' or 'unassessable' based on the physician's evaluation of the overall participant's disease related factors after 24 weeks. 'Improved' will be if determined as there is any effect of maintaining or improving disease related factors, 'unchanged' will be if disease related factors have not been changed compared with before administration, and not determined as there is any effect of maintaining symptoms. 'Aggravated' will be if disease related factors are worse than before administration and 'unassessable' will be if it cannot be determined due to insufficient information collected. 'Improved', 'unchanged', 'aggravated' will be further categorized as 'effective' ('improved') and 'ineffective' ('unchanged' and 'aggravated'). | up to 24 weeks |