PMS of Trazenta on the Long-term Use as Add-on Therapy
Post Marketing Surveillance on Long Term Drug Use of Trazenta® Tablets as add-on Therapy in Patients With Type 2 Diabetes Mellitus
1 other identifier
observational
4,057
1 country
1
Brief Summary
Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as add-on therapy in patients with type 2 diabetes mellitus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2013
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
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 8, 2013
CompletedFirst Posted
Study publicly available on registry
July 22, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2018
CompletedResults Posted
Study results publicly available
October 2, 2019
CompletedOctober 2, 2019
September 1, 2019
5.3 years
July 8, 2013
September 6, 2019
September 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Drug Related Adverse Events
Percentage of participants with drug related adverse events.
From first drug administration until last drug administration, up to approximately 156 weeks.
Secondary Outcomes (1)
The Mean Change From Baseline to Last Observation of the Treatment Period in Haemoglobin A1c (HbA1c)
Baseline (before administration of treatment) and last observation of the treatment period; up to 156 weeks.
Study Arms (1)
Trazenta
Interventions
Eligibility Criteria
3000 patients with type 2 Diabetes Mellitus
You may qualify if:
- Patients with type 2 diabetes mellitus who are treated with anti-diabetic drugs and have never been treated with Trazenta® Tablets (linagliptin) before enrollment will be included.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boehringer Ingelheimlead
- Eli Lilly and Companycollaborator
Study Sites (1)
Unknown Facility
Multiple Locations, Japan
Related Publications (1)
Ito T, Naito Y, Shimmoto N, Ochiai K, Hayashi N, Okamura T. Long-term safety and effectiveness of linagliptin as add-on therapy in Japanese patients with type 2 diabetes: final results of a 3-year post-marketing surveillance. Expert Opin Drug Saf. 2021 Mar;20(3):363-372. doi: 10.1080/14740338.2021.1859477. Epub 2020 Dec 27.
PMID: 33269625DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was conducted in an unblinded manner and without controls. The explanatory power of the study results was limited and the study results should be interpreted with the necessary caution.
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
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2013
First Posted
July 22, 2013
Study Start
July 1, 2013
Primary Completion
October 4, 2018
Study Completion
October 4, 2018
Last Updated
October 2, 2019
Results First Posted
October 2, 2019
Record last verified: 2019-09