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

July 6, 2018 updated by: Boehringer Ingelheim

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Design:

Post Marketing study- Observational study

Study Type

Observational

Enrollment (Actual)

3219

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Korean patients with T2DM

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Type 2 Diabetes Mellitus
Drug: Trajenta tablet
Linagliptin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 26 weeks (long-term surveillance)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
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.
24 Weeks
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).
24 Weeks
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).
Baseline and Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Collaborators

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2012

Primary Completion (Actual)

July 11, 2017

Study Completion (Actual)

July 11, 2017

Study Registration Dates

First Submitted

October 1, 2012

First Submitted That Met QC Criteria

October 15, 2012

First Posted (Estimate)

October 16, 2012

Study Record Updates

Last Update Posted (Actual)

January 11, 2019

Last Update Submitted That Met QC Criteria

July 6, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1218.104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Trajenta tablet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe