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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03761797
Recruitment Status : Completed
First Posted : December 3, 2018
Last Update Posted : June 7, 2021
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: TRADIANCE® Combination Tablets AP Drug: TRADIANCE® Combination Tablets BP

Study Design
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Study Type : Observational
Actual Enrollment : 1164 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Surveillance in Japan on Long Term Drug Use of TRADIANCE® Combination Tablets AP and BP in Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : January 15, 2019
Actual Primary Completion Date : March 10, 2021
Actual Study Completion Date : April 27, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse drug reactions (ADRs). [ Time Frame: Up to 52 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with type 2 Diabetes Mellitus
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03761797


Locations
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Japan
Nippon Boehringer Ingelheim Co., Ltd
Tokyo, Japan, 1416017
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
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Study Chair: Rie Ikeda, 81364172200 zzCDMJP_PV_PMS@boehringer-ingelheim.com
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03761797    
Other Study ID Numbers: 1275-0026
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: June 7, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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'.
URL: https://mystudywindow.com/msw/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases