MedDataX Logo

A Regulatory Requirement Non Interventional Study to Monitor Safety and Effectiveness of Trajenta Duo in Type 2 Diabetes Patients in Korea

NCT ID: NCT01903356

Last Updated: 2018-12-21

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

724 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-11

Study Completion Date

2017-06-10

Brief Summary

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

The primary objective of this study is to monitor the safety profile of Trajenta Duo in Korean patients with type 2 diabetes mellitus (T2DM) in a routine clinical setting.

Detailed Description

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

Study Design:

Post Marketed Study- Observational study

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

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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

Patients with T2DM

Trajenta duo

Intervention Type DRUG

Linagliptin and Metformin

Interventions

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

Trajenta duo

Linagliptin and Metformin

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

1. No previous exposure to Trajenta, Trajenta Duo
2. Should have been started on Trajenta Duo in accordance with the approved label in Korea
3. No current participation in clinical trials
4. No metformin is inappropriate due to contraindications
5. Must sign on the data release consent form

Exclusion Criteria

Individuals with any of the following characteristics will not be able to enter this study:

1. Previous exposure to Trajenta, Trajenta Duo
2. Current participation in clinical trials
3. Patients for whom metformin is inappropriate due to contraindications
Minimum Eligible Age

18 Years

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, , South Korea

Site Status

Countries

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

South Korea

Provided Documents

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

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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

1288.22

Identifier Type: -

Identifier Source: org_study_id