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
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT04952779
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 750
- 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).
- Participants who are or have previously been on Xultophy® therapy.
- Known or suspected hypersensitivity to Xultophy® (the active substance or any of the excipients).
- Previous participation in this study. Participation is defined as having given informed consent in this study.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Xultophy® Xultophy® (insulin degludec/liraglutide) Korean adults with type 2 diabetes mellitus (T2DM) initiating Xultophy® under routine clinical practice and according to approved label in Korea.
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events (AEs) by preferred term baseline (Visit1, 0 week) to 26 weeks Count of events
- Secondary Outcome Measures
Name Time Method Change in Glycosylated Haemoglobin (HbA1c) Visit 1 (0 week), Visit 3 (13 weeks) Percentage
Level 3 hypoglycaemia (severe) or level 2 hypoglycaemia Visit1 (0 week) to 26 weeks Plasma Glucose (PG) less than 54 mg/dL (3.0 mmol/L)
Change in body weight Visit 1 (0 week), Visit 4 (26 weeks) kilograms
Change of Xultophy® dose Visit (0 week), Visit 4 (26 weeks) Units
Change in HbA1c Visit 1 (0 week), Visit 4 (26 weeks) Percentage
Individuals achieving HbA1c target less than 7.0 % Visit 1 (0 week), Visit 4 (26 weeks) Percentage
Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG) Visit 1 (0 week), Visit 4 (26 weeks) mg/dl
Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG) Visit 1 (0 week), Visit 3 (26 weeks) mg/dl
Trial Locations
- Locations (30)
KangNam Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Isam Hospital
🇰🇷Busan, Korea, Republic of
Dongtan Jeil Women's Hospital
🇰🇷Hwasung-si, Korea, Republic of
Nowon Eulji Medical Center, Eulji University
🇰🇷Seoul, Korea, Republic of
Yonsei Leehyunchul Internal Medicine
🇰🇷Seoul, Korea, Republic of
Inje University Seoul Paik Hospital
🇰🇷Seoul, Korea, Republic of
Seoul Saint Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Sahm Yook Medical Center
🇰🇷Seoul, Korea, Republic of
St. Mary's Hospital, The Catholic University of Korea
🇰🇷Seoul, Korea, Republic of
Keimyung University Dongsan Hospital
🇰🇷Daegu, Korea, Republic of
Gangdong Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Daejeon Endo Internal Medicine Clinic
🇰🇷Daejeon, Korea, Republic of
The Catholic University of Korea. St. Vincent's Hospital
🇰🇷Suwon-si, Gyeonggi-do, Korea, Republic of
Soonchunhyang University Hospital
🇰🇷Cheonan, Chungcheongnam-do, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Eulji University Hospital_Daejeon
🇰🇷Daejeon, Korea, Republic of
Chungbuk National University Hospital
🇰🇷Daejeon, Korea, Republic of
Dongguk University Ilsan Hospital
🇰🇷Goyang, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Hyewon Medical Foundation Sejong General Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Ajou University Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Gyeongsang National University Hospital
🇰🇷Gyeongsangnam-do, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
ChonBuk Nataional University Hospital
🇰🇷Jeonju, Korea, Republic of
Hanil General Hospital
🇰🇷Seoul, Korea, Republic of
Uijeongbu Eulji university Hospital
🇰🇷Uijeongbu, Korea, Republic of
Ulsan Hospital
🇰🇷Ulsan, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of