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Clinical Trial Details

Trial ID: L4960
Source ID: NCT04952779
Associated Drug: Xultophy® (Insulin Degludec/Liraglutide)
Title: 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
Acronym:
Status: ENROLLING_BY_INVITATION
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Xultophy® (insulin degludec/liraglutide)
Outcome Measures: Primary: Incidence of Adverse Events (AEs) by preferred term, Count of events, baseline (Visit1, 0 week) to 26 weeks | Secondary: Level 3 hypoglycaemia (severe) or level 2 hypoglycaemia, Plasma Glucose (PG) less than 54 mg/dL (3.0 mmol/L), Visit1 (0 week) to 26 weeks|Change in body weight, Kilograms, Visit 1 (0 week), Visit 3 (13 weeks)|Change in body weight, kilograms, Visit 1 (0 week), Visit 4 (26 weeks)|Change of Xultophy® dose, Units, Visit 1 (0 week), 13 weeks (Visit 3)|Change of Xultophy® dose, Units, Visit (0 week), Visit 4 (26 weeks)|Change in Glycosylated Haemoglobin (HbA1c), Percentage, Visit 1 (0 week), Visit 3 (13 weeks)|Change in HbA1c, Percentage, Visit 1 (0 week), Visit 4 (26 weeks)|Individuals achieving HbA1c target less than 7.0 %, Percentage, Visit 1 (0 week), Visit 3 (13 weeks)|Individuals achieving HbA1c target less than 7.0 %, Percentage, Visit 1 (0 week), Visit 4 (26 weeks)|Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG), mg/dl, Visit 1 (0 week), Visit 3 (13 weeks)|Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG), mg/dl, Visit 1 (0 week), Visit 4 (26 weeks)|Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG), mg/dl, Visit 1 (0 week), Visit 3 (13 weeks)|Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG), mg/dl, Visit 1 (0 week), Visit 3 (26 weeks)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 750
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2021-06-02
Completion Date: 2024-10-31
Results First Posted:
Last Update Posted: 2024-09-19
Locations: Daejeon Endo Internal Medicine Clinic, Daejeon, Cheongsa-ro, Seo-gu, 35220, Korea, Republic of|Soonchunhyang University Hospital, Cheonan, Chungcheongnam-do, 31151, Korea, Republic of|Isam Hospital, Busan, 47354, Korea, Republic of|Inje University Busan Paik Hospital, Busan, 47392, Korea, Republic of|Kosin University Gospel Hospital, Busan, 49267, Korea, Republic of|Keimyung University Dongsan Medical Center, Daegu, 42601, Korea, Republic of|Eulji University Hospital_Daejeon, Daejeon, 302-120, Korea, Republic of|Daejeon Endo Internal Medicine Clinic, Daejeon, 35220, Korea, Republic of|Chungbuk National University Hospital, Daejeon, 361-711, Korea, Republic of|Dongguk University Ilsan Hospital, Goyang, 10326, Korea, Republic of|Seoul National University Bundang Hospital, Gyeonggi-do, 13620, Korea, Republic of|Hyewon Medical Foundation Sejong General Hospital, Gyeonggi-do, 14754, Korea, Republic of|Ajou University Hospital, Gyeonggi-do, 16499, Korea, Republic of|Gyeongsang National University Hospital, Gyeongsangnam-do, 52727, Korea, Republic of|Dongtan Jeil Women's Hospital, Hwasung-si, 18450, Korea, Republic of|Inha University Hospital, Incheon, 22332, Korea, Republic of|ChonBuk Nataional University Hospital, Jeonju, 561-712, Korea, Republic of|Hanil General Hospital, Seoul, 01450, Korea, Republic of|Nowon Eulji Medical Center, Eulji University, Seoul, 01830, Korea, Republic of|Yonsei Leehyunchul Internal Medicine, Seoul, 04058, Korea, Republic of|Inje University Seoul Paik Hospital, Seoul, 04551, Korea, Republic of|Seoul Saint Mary's Hospital, Seoul, 06591, Korea, Republic of|Sahm Yook Medical Center, Seoul, 130711, Korea, Republic of|Uijeongbu Eulji university Hospital, Uijeongbu, 11759, Korea, Republic of|Ulsan Hospital, Ulsan, 44686, Korea, Republic of|Ulsan University Hospital, Ulsan, 682-060, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT04952779