PMID- 37468685
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230922
IS  - 1869-6953 (Print)
IS  - 1869-6961 (Electronic)
IS  - 1869-6961 (Linking)
VI  - 14
IP  - 10
DP  - 2023 Oct
TI  - Safety and Clinical Outcomes of Insulin Degludec in Korean Patients with Diabetes 
      in Real-World Practices: A Prospective, Observational Study.
PG  - 1659-1672
LID - 10.1007/s13300-023-01448-8 [doi]
AB  - INTRODUCTION: To investigate the safety and effectiveness of insulin degludec 
      (IDeg) in a real-world population of Korean patients with diabetes requiring 
      insulin therapy. METHODS: This was a multicenter, prospective, single-arm, 
      open-label, non-interventional study. Patients aged >/= 12 months and treated with 
      previous glucose-lowering medications were eligible to switch to IDeg. The 
      primary endpoint was the incidence of adverse events (AEs), and the secondary 
      endpoints were changes in glycated hemoglobin (HbA1c), fasting plasma glucose 
      (FPG), postprandial glucose (PPG), and target HbA1c < 7.0%. RESULTS: In total, 
      3225 and 2450 patients were included in the safety analysis set (SAS) and 
      effectiveness analysis set (EAS), respectively. The mean baseline HbA1c and 
      duration of diabetes were 9.4% and 13.0 years, respectively. Adverse events were 
      reported in 740 patients (22.9%); the majority were mild and resolved. 
      Significant improvements were observed in HbA1c, FPG, and PPG at week 26 (all 
      p < 0.0001). The target of HbA1c < 7% was achieved in 22.2% of patients at week 
      26. CONCLUSION: In real-world clinical practice, 26 weeks of IDeg treatment 
      resulted in significant reductions in glycemic parameters with a low incidence of 
      AEs in Korean patients with diabetes. No new safety signals were observed. 
      CLINICAL TRIALS REGISTRY AND REGISTRATION NUMBER: This trial is registered under 
      ClinicalTrials.gov (NCT02779413) and the universal trial number is 
      [U1111-1176-2287].
CI  - (c) 2023. The Author(s).
FAU - Lee, Byung Wan
AU  - Lee BW
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, 
      Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of 
      Korea.
FAU - Ahn, Kyu Jeung
AU  - Ahn KJ
AD  - Department of Endocrinology and Metabolism, Kyung Hee University Hospital at 
      Gangdong, College of Medicine, Kyung Hee University, Seoul, Republic of Korea.
FAU - Cho, Ho Chan
AU  - Cho HC
AD  - Department of Clinical Endocrinology, Keimyung University Dongsan Hospital, 
      Keimyung University School of Medicine, Daegu, Republic of Korea.
FAU - Lee, Eun Young
AU  - Lee EY
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul 
      St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 
      Seoul, Republic of Korea.
FAU - Min, KyungWan
AU  - Min K
AD  - Department of Endocrinology and Metabolism, Nowon Eulji Medical Center, Eulji 
      University School of Medicine, Seoul, Republic of Korea.
FAU - Dahaoui, Amine
AU  - Dahaoui A
AD  - Novo Nordisk Pharma Korea Limited, Seoul, Republic of Korea.
FAU - Jeong, Jin Sook
AU  - Jeong JS
AD  - Novo Nordisk Pharma Korea Limited, Seoul, Republic of Korea.
FAU - Lim, Hyo Jin
AU  - Lim HJ
AD  - Novo Nordisk Pharma Korea Limited, Seoul, Republic of Korea.
FAU - Jang, Hak Chul
AU  - Jang HC
AD  - Department of Internal Medicine, Seoul National University Bundang Hospital, 
      Seoul National University College of Medicine, Seongnam, Republic of Korea. 
      janghak@snu.ac.kr.
LA  - eng
SI  - ClinicalTrials.gov/NCT02779413
PT  - Journal Article
DEP - 20230719
PL  - United States
TA  - Diabetes Ther
JT  - Diabetes therapy : research, treatment and education of diabetes and related 
      disorders
JID - 101539025
PMC - PMC10499774
OTO - NOTNLM
OT  - Basal insulin
OT  - Diabetes
OT  - Glycemic control
OT  - Insulin treatment
OT  - Real-world practice
COIS- Byung Wan Lee, Kyu Jeung Ahn, Ho Chan Cho, Eun Young Lee, KyungWan Min, and Hak 
      Chul declare that they have no competing interests. Amine Dahaoui, Jin Sook 
      Jeong, and Hyo Jin Lim are full-time employees of Novo Nordisk Pharma Korea 
      Limited.
EDAT- 2023/07/20 01:06
MHDA- 2023/07/20 01:07
PMCR- 2023/07/19
CRDT- 2023/07/19 23:30
PHST- 2023/01/30 00:00 [received]
PHST- 2023/07/06 00:00 [accepted]
PHST- 2023/07/20 01:07 [medline]
PHST- 2023/07/20 01:06 [pubmed]
PHST- 2023/07/19 23:30 [entrez]
PHST- 2023/07/19 00:00 [pmc-release]
AID - 10.1007/s13300-023-01448-8 [pii]
AID - 1448 [pii]
AID - 10.1007/s13300-023-01448-8 [doi]
PST - ppublish
SO  - Diabetes Ther. 2023 Oct;14(10):1659-1672. doi: 10.1007/s13300-023-01448-8. Epub 
      2023 Jul 19.