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

N/ACompletedNCT01903356

Boehringer Ingelheim724 enrolled

Overview

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.

Study Design: Post Marketed Study- Observational study

Study Type

OBSERVATIONAL

Enrollment

724

Conditions

Diabetes Mellitus, Type 2

Interventions

Trajenta duoDRUG

Linagliptin and Metformin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: Potential subjets must meet all of the following inclusion criteria to enter this trial: 1. No previous exposure to Trajenta, Trajenta Duo 2. Should have been started on Trajenta Duo in accordance with the approved label in Korea 3. No current participation in clinical trials 4. No metformin is inappropriate due to contraindications 5. 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: 1. Previous exposure to Trajenta, Trajenta Duo 2. Current participation in clinical trials 3. Patients for whom metformin is inappropriate due to contraindications

Locations (1)

Unnamed facility

Multiple Locations, South Korea

Outcomes

Primary Outcomes

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

Time frame: Up to 26 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 24 Weeks

Data from ClinicalTrials.gov

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