A Long-term Study on the Side Effects of TRADIANCE in Japanese Patients With Type 2 Diabetes

April 20, 2022 updated by: Boehringer Ingelheim

Post Marketing Surveillance in Japan on Long Term Drug Use of TRADIANCE® Combination Tablets AP and BP in Patients With Type 2 Diabetes Mellitus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1164

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

  • Japan
      • Tokyo, Japan, 1416017
        • Nippon Boehringer Ingelheim Co., Ltd

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with type 2 Diabetes Mellitus

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

None

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects with type 2 Diabetes Mellitus
Drug: TRADIANCE® Combination Tablets AP
Fixed dose combination
Drug: TRADIANCE® Combination Tablets BP
Fixed dose combination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Drug Reactions (ADRs)
Time Frame: From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
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.

Collaborators and Investigators

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

Sponsor

Boehringer Ingelheim

Collaborators

Eli Lilly and Company

Investigators

  • Study Chair: Rie Ikeda, 81364172200, zzCDMJP_PV_PMS@boehringer-ingelheim.com

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.

General Publications

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)

January 15, 2019

Primary Completion (Actual)

March 10, 2021

Study Completion (Actual)

April 27, 2021

Study Registration Dates

First Submitted

November 30, 2018

First Submitted That Met QC Criteria

November 30, 2018

First Posted (Actual)

December 3, 2018

Study Record Updates

Last Update Posted (Actual)

January 23, 2023

Last Update Submitted That Met QC Criteria

April 20, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1275-0026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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'.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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.

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