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
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)
1 other identifier
observational
3,219
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2012
CompletedFirst Posted
Study publicly available on registry
October 16, 2012
CompletedStudy Start
First participant enrolled
November 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 11, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 11, 2017
CompletedResults Posted
Study results publicly available
January 11, 2019
CompletedJanuary 11, 2019
July 1, 2018
4.7 years
October 1, 2012
July 6, 2018
July 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Up to 26 weeks (long-term surveillance)
Secondary Outcomes (4)
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
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)
Baseline and Week 24
Study Arms (1)
Patients with Type 2 Diabetes Mellitus
Interventions
Eligibility Criteria
Korean patients with T2DM
You may qualify if:
- 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
You may not qualify if:
- Patients with previous exposure to Trajenta and current participation in clinical trials
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boehringer Ingelheimlead
- Eli Lilly and Companycollaborator
Study Sites (1)
Unknown Facility
Multiple Locations, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2012
First Posted
October 16, 2012
Study Start
November 16, 2012
Primary Completion
July 11, 2017
Study Completion
July 11, 2017
Last Updated
January 11, 2019
Results First Posted
January 11, 2019
Record last verified: 2018-07