A Regulatory Requirement Non Interventional Study to Monitor Safety and Effectiveness of Trajenta Duo in Type 2 Diabetes Patients in Korea

Study Overview
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Brief Summary
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The primary objective of this study is to monitor the safety profile of Trajenta Duo in Korean patients with type 2 diabetes mellitus (T2DM) in a routine clinical setting.

Detailed Description
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Study Design: Post Marketed Study- Observational study

Official Title
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A Regulatory Requirement Non Interventional Study to Monitor the Safety and Effectiveness of Trajenta Duo® (Linagliptin/Metformin HCl, 2.5 mg/500 mg, 2.5 mg/850 mg and 2.5 mg/1000 mg, b.i.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: Trajenta duo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Potential subjets must meet all of the following inclusion criteria to enter this trial: No previous exposure to Trajenta, Trajenta Duo Should have been started on Trajenta Duo in accordance with the approved label in Korea No current participation in clinical trials No metformin is inappropriate due to contraindications Must sign on the data release consent form Exclusion criteria: Individuals with any of the following characteristics will not be able to enter this study: Previous exposure to Trajenta, Trajenta Duo Current participation in clinical trials Patients for whom metformin is inappropriate due to contraindications

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Patients with T2DM<br> | Drug: Trajenta duo<br>* Linagliptin and Metformin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence Rate of Adverse Events (AE) | The incidence rate is the number of new cases per population at risk in a given time period. The incidence rate was calculated in patients who take at least one Trajenta Duo | Up to 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment. | This outcome has measured difference between HbA1c values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any study medication. HbA1c is a form of hemoglobin, a blood pigment that carries oxygen, which is bound to glucose. The term HbA1c also refers to glycated hemoglobin. High levels of HbA1c (Normal range is less than 6%) indicate poorer control of diabetes than level in normal range. | Baseline and Week 24 | 
| Target Effectiveness Response Rate | Occurrence of treatment to target effectiveness response is an HbA1c under treatment of < 6.5% after 24 weeks of treatment. This outcome measures percentage of patients achieving HbA1c < 6.5% after 24 weeks. | 24 Weeks | 
| Relative Effectiveness Response Rate | Occurrence of relative effectiveness response. This outcome measures percentage of patients for which HbA1c has reduced by at least 0.5% after 24 weeks. | 24 Weeks | 
| Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment. | This outcome has measured difference between Fasting Plasma Glucose (FPG) values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any study medication. | 24 Weeks |