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
- Diseases
- Type 2 diabetes
- 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
Sites (31)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Isam Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Inje University Busan Paik Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Kosin University Gospel Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Soon Chun Hyang University Hospital Cheonan Coordinator of this site? Confirm its status | Cheonan | South Korea | Unknown status |
| Keimyung University Dongsan Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Keimyung University - Dongsan Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Daejeon Endo Internal Medicine Clinic Coordinator of this site? Confirm its status | Daejeon | South Korea | Unknown status |
| Eulji University Hospital, Daejeon Coordinator of this site? Confirm its status | Daejeon | South Korea | Unknown status |
| Chungbuk National University Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Unknown status |
| Dongguk University Ilsan Hospital Coordinator of this site? Confirm its status | Goyang | South Korea | Unknown status |
| Hyewon Medical Foundation Sejong General Hospital Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Unknown status |
| Ajou University Hospital Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Unknown status |
| Dongtan Jeil Women's Hospital Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Unknown status |
| Gyeongsang National University Hospital Coordinator of this site? Confirm its status | Gyeongsangnam-do | South Korea | Unknown status |
| Inha University Hospital Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| jeonbuk National University Hospital Coordinator of this site? Confirm its status | Jeonju | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| The Catholic University of Korea, Seoul ST. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| KangNam Sacred Heart Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Nowon Eulji Medical Center, Eulji University Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Kyung Hee University Hospital at Gangdong Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Hanil General Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Inje University Seoul Paik Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Sahm Yook Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Jae Clinic Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Yonsei Leehyunchul Internal Medicine Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea Yeouido St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea St. Vincent's Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
| Uijeongbu Eulji university Hospital Coordinator of this site? Confirm its status | Uijeongbu-si | South Korea | Unknown status |
| Ulsan Hospital Coordinator of this site? Confirm its status | Ulsan | South Korea | Unknown status |
| Ulsan University Hospital Coordinator of this site? Confirm its status | Ulsan | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.