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.
Study Type
OBSERVATIONAL
Enrollment
750
Xultophy® is a fixed ratio combination of the long-acting basal insulin, insulin degludec, and the glucagon-like peptide 1 receptor agonist (GLP-1 RA), liraglutide, administered under the skin. Patients will be treated according to routine clinical practice at the discretion of the treating physician according to the label approved by MFDS. The assignment of the patient to Xultophy® is not decided in advance by the protocol but falls within current practice and the prescription of Xultophy® is clearly separated from the decision to include the patient in the study.
Incidence of Adverse Events (AEs) by preferred term
Count of events
Time frame: baseline (Visit1, 0 week) to 26 weeks
Level 3 hypoglycaemia (severe) or level 2 hypoglycaemia
Plasma Glucose (PG) less than 54 mg/dL (3.0 mmol/L)
Time frame: Visit1 (0 week) to 26 weeks
Change in body weight
Kilograms
Time frame: Visit 1 (0 week), Visit 3 (13 weeks)
Change in body weight
kilograms
Time frame: Visit 1 (0 week), Visit 4 (26 weeks)
Change of Xultophy® dose
Units
Time frame: Visit 1 (0 week), 13 weeks (Visit 3)
Change of Xultophy® dose
Units
Time frame: Visit (0 week), Visit 4 (26 weeks)
Change in Glycosylated Haemoglobin (HbA1c)
Percentage
Time frame: Visit 1 (0 week), Visit 3 (13 weeks)
Change in HbA1c
Percentage
Time frame: Visit 1 (0 week), Visit 4 (26 weeks)
Individuals achieving HbA1c target less than 7.0 %
Percentage
Time frame: Visit 1 (0 week), Visit 3 (13 weeks)
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Daejeon Endo Internal Medicine Clinic
Daejeon, Cheongsa-ro, Seo-gu, South Korea
Soon Chun Hyang University Hospital Cheonan
Cheonan, Chungcheongnam-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
The Catholic University of Korea, ST. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Isam Hospital
Busan, South Korea
Inje University Busan Paik Hospital
Busan, South Korea
Kosin University Gospel Hospital
Busan, South Korea
Keimyung University Dongsan Hospital
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
...and 22 more locations
Individuals achieving HbA1c target less than 7.0 %
Percentage
Time frame: Visit 1 (0 week), Visit 4 (26 weeks)
Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG)
mg/dl
Time frame: Visit 1 (0 week), Visit 3 (13 weeks)
Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG)
mg/dl
Time frame: Visit 1 (0 week), Visit 4 (26 weeks)
Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)
mg/dl
Time frame: Visit 1 (0 week), Visit 3 (13 weeks)
Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)
mg/dl
Time frame: Visit 1 (0 week), Visit 3 (26 weeks)