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A Study to Evaluate Safety and Effectiveness in Patients of All Age Groups Excluding Less Than 12 Months Old Infants With Diabetes Mellitus in Routine Clinical Practice in Korea

NCT ID: NCT02779413

Last Updated: 2020-04-21

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

3303 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-02

Study Completion Date

2019-06-24

Brief Summary

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This study is conducted in Asia. The aim of the study is to evaluate safety and effectiveness in patients of all age groups excluding less than 12 month old infants with diabetes mellitus in routine clinical practice in Korea.

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Detailed Description

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Conditions

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Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Insulin degludec

insulin degludec

Intervention Type DRUG

Patients will be treated with commercially available Tresiba® FlexTouch® according to routine clinical practice at the discretion of the treating physician.

Interventions

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insulin degludec

Patients will be treated with commercially available Tresiba® FlexTouch® according to routine clinical practice at the discretion of the treating physician.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) - The decision to initiate treatment with commercially available Tresiba® FlexTouch® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study - Male or Female, Age at least 12 months, at the time of signing informed consent with type 1 or type 2 diabetes mellitus and who is scheduled to start treatment with Tresiba® FlexTouch® based on the clinical judgment of their treating physician as specified in the Korean-Prescribing Information (KPI) Exclusion Criteria: - Previous participation in this study. Participation is defined as having given informed consent in this study - Patients who are or have previously treated with Tresiba® FlexTouch® - Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. However, paediatric patients can be enrolled when the patient's primary caregiver (e.g. parents) or legally acceptable representatives (LAR) are capable of giving study specific signed informed consent. Any chronic disorder or severe disease which in the opinion of the investigator might jeopardise patient's safety or compliance with the protocol - Female who is pregnant, breast-feeding or intends to become pregnant and is of child-baring potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
Minimum Eligible Age

12 Months

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

Bucheon-si, , South Korea

Site Status

Novo Nordisk Investigational Site

Busan, , South Korea

Site Status

Novo Nordisk Investigational Site

Busan, , South Korea

Site Status

Novo Nordisk Investigational Site

Busan, , South Korea

Site Status

Novo Nordisk Investigational Site

Busan, , South Korea

Site Status

Novo Nordisk Investigational Site

Busan, , South Korea

Site Status

Novo Nordisk Investigational Site

Chungcheongnam-do, , South Korea

Site Status

Novo Nordisk Investigational Site

Daegu, , South Korea

Site Status

Novo Nordisk Investigational Site

Daegu, , South Korea

Site Status

Novo Nordisk Investigational Site

Daejeon, , South Korea

Site Status

Novo Nordisk Investigational Site

Daejeon, , South Korea

Site Status

Novo Nordisk Investigational Site

Gangwon-do, , South Korea

Site Status

Novo Nordisk Investigational Site

Gangwon-do, , South Korea

Site Status

Novo Nordisk Investigational Site

Gangwon-do, , South Korea

Site Status

Novo Nordisk Investigational Site

Gyeonggi-do, , South Korea

Site Status

Novo Nordisk Investigational Site

Gyeonggi-do, , South Korea

Site Status

Novo Nordisk Investigational Site

Gyeonggi-do, , South Korea

Site Status

Novo Nordisk Investigational Site

Gyeongsangbuk-do, , South Korea

Site Status

Novo Nordisk Investigational Site

Gyeongsangbuk-do, , South Korea

Site Status

Novo Nordisk Investigational Site

Gyeongsangnam-do, , South Korea

Site Status

Novo Nordisk Investigational Site

Incheon, , South Korea

Site Status

Novo Nordisk Investigational Site

Incheon, , South Korea

Site Status

Novo Nordisk Investigational Site

Incheon, , South Korea

Site Status

Novo Nordisk Investigational Site

Jeonju, , South Korea

Site Status

Novo Nordisk Investigational Site

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

Site Status

Novo Nordisk Investigational Site

Seongnam-si, , 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

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

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

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

Seoul, , South Korea

Site Status

Novo Nordisk Investigational Site

Suwon, , South Korea

Site Status

Novo Nordisk Investigational Site

Suwon-si, Gyeonggi-do, , 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

References

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Lee BW, Ahn KJ, Cho HC, Lee EY, Min K, Dahaoui A, Jeong JS, Lim HJ, Jang HC. Safety and Clinical Outcomes of Insulin Degludec in Korean Patients with Diabetes in Real-World Practices: A Prospective, Observational Study. Diabetes Ther. 2023 Oct;14(10):1659-1672. doi: 10.1007/s13300-023-01448-8. Epub 2023 Jul 19.

Reference Type DERIVED
PMID: 37468685 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1176-2287

Identifier Type: OTHER

Identifier Source: secondary_id

NN1250-4110

Identifier Type: -

Identifier Source: org_study_id

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