Clinical trial NCT04952779: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2021-07-07
Enrollment: 750
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Korean adults with type 2 diabetes mellitus (T2DM) initiating Xultophy® under routine clinical practice and according to approved label in Korea.

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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Incidence of Adverse Events (AEs) by preferred term
timeFrame: baseline (Visit1, 0 week) to 26 weeks
Secondary outcomes:
measure: Level 3 hypoglycaemia (severe) or level 2 hypoglycaemia
timeFrame: Visit1 (0 week) to 26 weeks
measure: Change in body weight
timeFrame: Visit 1 (0 week), Visit 3 (13 weeks)
measure: Change in body weight
timeFrame: Visit 1 (0 week), Visit 4 (26 weeks)
measure: Change of Xultophy® dose
timeFrame: Visit 1 (0 week), 13 weeks (Visit 3)
measure: Change of Xultophy® dose
timeFrame: Visit (0 week), Visit 4 (26 weeks)
measure: Change in Glycosylated Haemoglobin (HbA1c)
timeFrame: Visit 1 (0 week), Visit 3 (13 weeks)
measure: Change in HbA1c
timeFrame: Visit 1 (0 week), Visit 4 (26 weeks)
measure: Individuals achieving HbA1c target less than 7.0 %
timeFrame: Visit 1 (0 week), Visit 3 (13 weeks)
measure: Individuals achieving HbA1c target less than 7.0 %
timeFrame: Visit 1 (0 week), Visit 4 (26 weeks)
measure: Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG)
timeFrame: Visit 1 (0 week), Visit 3 (13 weeks)
measure: Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG)
timeFrame: Visit 1 (0 week), Visit 4 (26 weeks)
measure: Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)
timeFrame: Visit 1 (0 week), Visit 3 (13 weeks)
measure: Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)
timeFrame: Visit 1 (0 week), Visit 3 (26 weeks)
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Daejeon Endo Internal Medicine Clinic
state: Cheongsa-ro, Seo-gu
city: Cheonan
country: Korea, Republic of
facility: Soonchunhyang University Hospital
state: Chungcheongnam-do
city: Busan
country: Korea, Republic of
facility: Isam Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daejeon
country: Korea, Republic of
facility: Eulji University Hospital_Daejeon
city: Daejeon
country: Korea, Republic of
facility: Daejeon Endo Internal Medicine Clinic
city: Daejeon
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Goyang
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Hyewon Medical Foundation Sejong General Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Hospital
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Hwasung-si
country: Korea, Republic of
facility: Dongtan Jeil Women's Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Jeonju
country: Korea, Republic of
facility: ChonBuk Nataional University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanil General Hospital
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center, Eulji University
city: Seoul
country: Korea, Republic of
facility: Yonsei Leehyunchul Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Inje University Seoul Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Gangdong Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Saint Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: KangNam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Sahm Yook Medical Center
city: Seoul
country: Korea, Republic of
facility: St. Mary's Hospital, The Catholic University of Korea
city: Suwon-si, Gyeonggi-do
country: Korea, Republic of
facility: The Catholic University of Korea. St. Vincent's Hospital
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu Eulji university Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency dept. 1452
role: STUDY_DIRECTOR
References: