Investigating the Safety Profile of Liraglutide Under Normal Conditions of Use in Korean Subjects With Type 2 Diabetes Mellitus

NCT ID: NCT01821846

Last Updated: 2017-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-20

Study Completion Date

2017-03-08

Brief Summary

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This trial is conducted in Asia. The aim of this study is to investigate the safety profile of liraglutide (Victoza®) under normal conditions of use in Korean subjects with type 2 diabetes mellitus.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Liraglutide

liraglutide

Intervention Type DRUG

Administered either alone or in combination therapy according to the package insert (PI). Self-administered once daily, at any time subcutaneously (s.c., under the skin) in the abdomen, thigh or upper arm).

Interventions

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liraglutide

Administered either alone or in combination therapy according to the package insert (PI). Self-administered once daily, at any time subcutaneously (s.c., under the skin) in the abdomen, thigh or upper arm).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with T2DM (Type 2 Diabetes Mellitus), including newly-diagnosed subjects, who require treatment with Victoza® according to the clinical judgment of their treating physician
* Subjects (and/or parents or the subject's legally acceptable representative) who are capable of giving study-specific signed informed consent before any collection of information

Exclusion Criteria

* Subjects with a hypersensitivity to Victoza® or to any of the excipients
* Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the study periods
* Subjects with personal or family history of medullary thyroid carcinoma (MTC)
* Subjects with multiple endocrine neoplasia syndrome type 2 (MEN2)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Pyungchon-Dong 896, Dongan-Gu, , South Korea

Site Status

Novo Nordisk Investigational Site

Seoul, , South Korea

Site Status

Novo Nordisk Investigational Site

Seoul, , South Korea

Site Status

Novo Nordisk Investigational Site

Seoul, , South Korea

Site Status

Novo Nordisk Investigational Site

Ulsan, , South Korea

Site Status

Novo Nordisk Investigational Site

Ulsan, , South Korea

Site Status

Novo Nordisk Investigational Site

Wŏnju, , South Korea

Site Status

Countries

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South Korea

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1132-2221

Identifier Type: OTHER

Identifier Source: secondary_id

NN2211-3929

Identifier Type: -

Identifier Source: org_study_id

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