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NCT04952779Completed

Regulatory Post Marketing Surveillance (rPMS) Study of Xultophy® (Insulin Degludec/Liraglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea

A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Regulatory Post Marketing Surveillance (rPMS) Study of Xultophy® (Insulin Degludec / Liraglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea

Source: ClinicalTrials.gov · Last updated 31 Dec 2025

Brief summary (registry, in English)

The aim of this study is to assess the safety and effectiveness of Xultophy® initiated according to label in adults with type 2 diabetes mellitus (T2DM) under routine clinical practice conditions. Participants will get Xultophy® as prescribed to them by the study doctor. The study will last for about 26 weeks.

Status (registry)
Completed
Study type
Observational
Enrollment
750 (actual)
First submitted
28 Jun 2021
Start date
2 Jun 2021
Primary completion date
15 Dec 2024
Lead sponsor
Novo Nordisk A/S
NCT number
NCT04952779

What you commit to

  • Study type: Observational
  • Participants enrolled: 750
  • From 2 Jun 2021 to the primary completion date, 15 Dec 2024
  • 31 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants who are or have previously been on Xultophy® therapy.
  • Previous participation in this study. Participation is defined as having given informed consent in this study.

Other illness

  • Known or suspected hypersensitivity to Xultophy® (the active substance or any of the excipients).

Other

  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Who the study is looking for

  • The decision to initiate treatment with commercially available Xultophy® has been made by the participant/Legally Acceptable Representative (LAR) and the study doctor before and independently from the decision to include the participant in this study.
  • Informed consent obtained before any study related activities. Study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
  • Male or female, age 19 years or older at the time of signing informed consent form.
  • Participants diagnosed (clinically) with T2DM and who is scheduled to start treatment with Xultophy® based on the clinical judgment of their treating physician as specified in the approved Korean-Prescribing information (local label).

Age in the registry: 19 years to - · Sex: All

Full criteria on ClinicalTrials.gov

Sites (31)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Isam Hospital
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BusanSouth KoreaUnknown status
Inje University Busan Paik Hospital
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BusanSouth KoreaUnknown status
Kosin University Gospel Hospital
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BusanSouth KoreaUnknown status
Soon Chun Hyang University Hospital Cheonan
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CheonanSouth KoreaUnknown status
Keimyung University Dongsan Hospital
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DaeguSouth KoreaUnknown status
Keimyung University - Dongsan Medical Center
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DaeguSouth KoreaUnknown status
Daejeon Endo Internal Medicine Clinic
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DaejeonSouth KoreaUnknown status
Eulji University Hospital, Daejeon
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DaejeonSouth KoreaUnknown status
Chungbuk National University Hospital
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DaejeonSouth KoreaUnknown status
Dongguk University Ilsan Hospital
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GoyangSouth KoreaUnknown status
Hyewon Medical Foundation Sejong General Hospital
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Gyeonggi-doSouth KoreaUnknown status
Ajou University Hospital
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Gyeonggi-doSouth KoreaUnknown status
Dongtan Jeil Women's Hospital
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Gyeonggi-doSouth KoreaUnknown status
Gyeongsang National University Hospital
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Gyeongsangnam-doSouth KoreaUnknown status
Inha University Hospital
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IncheonSouth KoreaUnknown status
jeonbuk National University Hospital
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JeonjuSouth KoreaUnknown status
Seoul National University Bundang Hospital
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Seongnam-siSouth KoreaUnknown status
The Catholic University of Korea, Seoul ST. Mary's Hospital
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SeoulSouth KoreaUnknown status
KangNam Sacred Heart Hospital
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SeoulSouth KoreaUnknown status
Nowon Eulji Medical Center, Eulji University
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SeoulSouth KoreaUnknown status
Kyung Hee University Hospital at Gangdong
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SeoulSouth KoreaUnknown status
Hanil General Hospital
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SeoulSouth KoreaUnknown status
Inje University Seoul Paik Hospital
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SeoulSouth KoreaUnknown status
Sahm Yook Medical Center
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SeoulSouth KoreaUnknown status
Jae Clinic
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SeoulSouth KoreaUnknown status
Yonsei Leehyunchul Internal Medicine
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SeoulSouth KoreaUnknown status
The Catholic University of Korea Yeouido St. Mary's Hospital
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SeoulSouth KoreaUnknown status
The Catholic University of Korea St. Vincent's Hospital
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SuwonSouth KoreaUnknown status
Uijeongbu Eulji university Hospital
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Uijeongbu-siSouth KoreaUnknown status
Ulsan Hospital
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UlsanSouth KoreaUnknown status
Ulsan University Hospital
Coordinator of this site? Confirm its status
UlsanSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.