A Non Interventional Study to Monitor the Safety and Effectiveness of Trajenta (Linagliptin, 5 mg, q.d) in Korean Patients With Type 2 Diabetes Mellitus

NCT ID: NCT01707147

Last Updated: 2019-01-11

Study Results

Results available

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

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3219 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-16

Study Completion Date

2017-07-11

Brief Summary

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The aim of this study is to monitor safety and efficacy of treatment with linagliptin in Korean patients with type 2 diabetes mellitus in routine clinical settings.

Detailed Description

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Study Design:

Post Marketing study- Observational study

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Type 2 Diabetes Mellitus

Trajenta tablet

Intervention Type DRUG

Linagliptin

Interventions

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Trajenta tablet

Linagliptin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients who have been started on Trajenta in accordance with the approved label in Korea Patients who have signed on the data release consent form

Exclusion Criteria

Patients with previous exposure to Trajenta and current participation in clinical trials
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Multiple Locations, , South Korea

Site Status

Countries

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South Korea

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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1218.104

Identifier Type: -

Identifier Source: org_study_id

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