A Long-term Study on the Side Effects of TRADIANCE in Japanese Patients With Type 2 Diabetes
Post Marketing Surveillance in Japan on Long Term Drug Use of TRADIANCE® Combination Tablets AP and BP in Patients With Type 2 Diabetes Mellitus
1 other identifier
observational
1,164
1 country
1
Brief Summary
Study objectives is to investigate the safety of long-term daily use of TRADIANCE® Combination Tablets AP and BP in Japanese patients with Type 2 Diabetes mellitus (T2DM) used in routine care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2018
CompletedFirst Posted
Study publicly available on registry
December 3, 2018
CompletedStudy Start
First participant enrolled
January 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2021
CompletedResults Posted
Study results publicly available
January 23, 2023
CompletedJanuary 23, 2023
April 1, 2022
2.2 years
November 30, 2018
April 20, 2022
April 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Drug Reactions (ADRs)
The number of participants with adverse drug reactions is reported.
From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Study Arms (1)
Subjects with type 2 Diabetes Mellitus
Interventions
Eligibility Criteria
Patients with type 2 Diabetes Mellitus
You may qualify if:
- Japanese patients with Type 2 Diabetes mellitus (T2DM) who are prescribed with TRADIANCE® Combination Tablets AP or BP
- Patients who have never been treated with TRADIANCE® Combination Tablets AP or BP before enrolment
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boehringer Ingelheimlead
- Eli Lilly and Companycollaborator
Study Sites (1)
Nippon Boehringer Ingelheim Co., Ltd
Tokyo, 1416017, Japan
Related Publications (1)
Inagaki N, Nishimoto T, Nishiya Y, Nitta D. Safety and effectiveness of empagliflozin and linagliptin fixed-dose combination therapy in Japanese patients with type 2 diabetes: final results of a one-year post-marketing surveillance study. Expert Opin Drug Saf. 2023 Feb;22(2):153-163. doi: 10.1080/14740338.2022.2107200. Epub 2022 Aug 16.
PMID: 35946927DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Rie Ikeda, 81364172200
zzCDMJP_PV_PMS@boehringer-ingelheim.com
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
November 30, 2018
First Posted
December 3, 2018
Study Start
January 15, 2019
Primary Completion
March 10, 2021
Study Completion
April 27, 2021
Last Updated
January 23, 2023
Results First Posted
January 23, 2023
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
- Access Criteria
- For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https:// trials.boehringer-ingelheim.com/trial\_results/ clinical\_submission\_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link http://trials.boehringeringelheim. com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.