PMS of Trazenta on the Long-term Use as Add-on Therapy

NCT ID: NCT01904383

Last Updated: 2019-10-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

4057 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-01

Study Completion Date

2018-10-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Trazenta

Trazenta

Intervention Type DRUG

1 tablet of 5 mg Trazenta tablets once daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Trazenta

1 tablet of 5 mg Trazenta tablets once daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.

Exclusion Criteria

None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Multiple Locations, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 33269625 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1218.147

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

GALLANT 8 Tesaglitazar Add-on to Metformin
NCT00251953 TERMINATED PHASE3
GALLANT 4 Tesaglitazar vs. Glibenclamide
NCT00255541 TERMINATED PHASE3