A Non Interventional Study to Monitor the Safety and Effectiveness of Trajenta (Linagliptin, 5 mg, q.d) in Korean Patients With Type 2 Diabetes Mellitus

Boehringer Ingelheim3,219 enrolled

Overview

The aim of this study is to monitor safety and efficacy of treatment with linagliptin in Korean patients with type 2 diabetes mellitus in routine clinical settings.

Study Design: Post Marketing study- Observational study

Study Type

OBSERVATIONAL

Enrollment

3,219

Conditions

Diabetes Mellitus, Type 2

Interventions

Trajenta tabletDRUG

Linagliptin

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion criteria: Patients who have been started on Trajenta in accordance with the approved label in Korea Patients who have signed on the data release consent form Exclusion criteria: Patients with previous exposure to Trajenta and current participation in clinical trials

Locations (1)

Unnamed facility

Multiple Locations, South Korea

Outcomes

Primary Outcomes

Percentage of Patients With Incidence of Adverse Events Who Had Taken at Least One Dose of Trajenta

Percentage of patients with incidence of any adverse events who had taken at least one dose of Trajenta.

Time frame: Up to 26 weeks (long-term surveillance)

Secondary Outcomes

Change From Baseline After 24 Weeks in Glycosylated Hemoglobin (HbA1c)

Change from baseline after 24 weeks in Glycosylated Hemoglobin (HbA1c).

Time frame: Baseline and Week 24

Percentage of Patients With Occurrence of Treat to Target Effectiveness Response, That is HbA1c Under Treatment of < 6.5% After 24 Weeks of Treatment

Percentage of patients with occurrence of treat to target effectiveness response, that is HbA1c under treatment of \< 6.5% after 24 weeks of treatment.

Time frame: 24 Weeks

Percentage of Patients With Occurrence of Relative Effectiveness Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment)

Percentage of patients with occurrence of relative effectiveness response (HbA1c lowering by at least 0.5% after 24 weeks of treatment).

Time frame: 24 Weeks

Change From Baseline After 24 Weeks in Fasting Plasma Glucose (FPG)

Change from baseline after 24 weeks in fasting plasma glucose (FPG).

Time frame: Baseline and Week 24

Data from ClinicalTrials.gov

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