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A Regulatory Post Marketing Surveillance (rPMS) Study of Ryzodeg® FlexTouch® (Insulin Degludec /Insulin Aspart) to Evaluate Safety and Effectiveness in Patients With Diabetes Mellitus in Routine Clinical Practice in Korea

NCT ID: NCT03416855

Last Updated: 2021-11-10

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

768 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-31

Study Completion Date

2020-05-19

Brief Summary

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The purpose of this study is to collect information about safety and effectiveness of Ryzodeg® FlexTouch® in participants with diabetes mellitus requiring insulin therapy under routine clinical practice conditions with the aim of identifying or quantifying a safety hazard, early detection of unknown safety problems. Participants will attend the clinic/hospital/medical institution according to usual practice and receive medical care, as agreed with the study doctor.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Overall population

Participants will be decided to be treated with Ryzodeg® FlexTouch® by physicians before the enrolment in the study based on clinical judgement in the diabetes management.

Insulin degludec /insulin aspart

Intervention Type DRUG

Commercially available Insulin degludec /insulin aspart (Ryzodeg® FlexTouch®) according to routine clinical practice at the discretion of the treating physician.

Interventions

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Insulin degludec /insulin aspart

Commercially available Insulin degludec /insulin aspart (Ryzodeg® FlexTouch®) according to routine clinical practice at the discretion of the treating physician.

Intervention Type DRUG

Other Intervention Names

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Ryzodeg® FlexTouch®

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - The decision to initiate treatment with commercially available Ryzodeg® 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 - Signed informed consent obtained before any study related activities.

Exclusion Criteria

Study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study - Age equals to or more than 2 years at the time of signing informed consent with diabetes mellitus (Type 1 or Type 2) and who is scheduled to start treatment with Ryzodeg® FlexTouch® based on the clinical judgment of their treating physician as specified in the Korean-Prescribing information (K-PI) Exclusion Criteria: - Patients who are or have previously been on Ryzodeg® FlexTouch® therapy - Known or suspected hypersensitivity to Ryzodeg® FlexTouch®, the active substance or any of the excipients - Previous participation in this study. Participation is defined as having given informed consent in this study - Female patient who is pregnant, breast-feeding or intends to become pregnant and is of childbearing potential and not using adequate contraceptive methods(adequate contraceptive measures as required by Korea regulation or practice) - Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Minimum Eligible Age

2 Years

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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Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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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

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

Daejeon, , South Korea

Site Status

Novo Nordisk Investigational Site

Gangwon-do, , South Korea

Site Status

Novo Nordisk Investigational Site

Goyang, , 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

Gyeonggi-do, , 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

Jeonju, , South Korea

Site Status

Novo Nordisk Investigational Site

Pusan, , 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

Countries

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South Korea

Other Identifiers

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1111-1194-8505

Identifier Type: OTHER

Identifier Source: secondary_id

NN5401-4196

Identifier Type: -

Identifier Source: org_study_id