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OpenTrials
Completed

NCT Number: NCT01707147

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, South Korea

About this study

Study Design:

Post Marketing study- Observational study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trajenta tablet

Drug

Linagliptin

Primary outcomes

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

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

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

Secondary outcomes

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

    Time frame: Baseline and Week 24

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

  2. 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 treat to target effectiveness response, that is HbA1c under treatment of < 6.5% after 24 weeks of treatment.

  3. 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

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

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

    Time frame: Baseline and Week 24

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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Oct 16, 2012
Registry last updated
Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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