PMID- 38410023 OWN - NLM STAT- Publisher LR - 20240227 IS - 2233-6087 (Electronic) IS - 2233-6079 (Linking) DP - 2024 Feb 27 TI - Efficacy and Safety of IDegAsp in a Real-World Korean Population with Type 2 Diabetes Mellitus. LID - 10.4093/dmj.2023.0297 [doi] AB - BACKGROUND: This study investigated the real-world efficacy and safety of insulin degludec/insulin aspart (IDegAsp) in Korean adults with type 2 diabetes mellitus (T2DM), whose insulin treatment was switched to IDegAsp. METHODS: This was a multicenter, retrospective, observational study comprising two 26-week treatment periods, before and after switching to IDegAsp, respectively. Korean adults with uncontrolled T2DM treated with basal or premix insulin (+/-oral antidiabetic drugs) were enrolled. The primary objective was to compare the degree of glycosylated hemoglobin (HbA1c) change in each 26-week observation period. The analyses included changes in HbA1c, fasting plasma glucose (FPG), body weight, proportion of participants achieving HbA1c <7.0%, hypoglycemic events, and total daily insulin dose (ClinicalTrials.gov, number NCT04656106). RESULTS: In total, 196 adults (mean age, 65.95 years; mean T2DM duration, 18.99 years) were analyzed. The change in both HbA1c and FPG were significantly different between the pre-switching and the post-switching period (0.28% vs. -0.51%, P<0.001; 5.21 mg/dL vs. -23.10 mg/dL, P=0.005), respectively. After switching, the rate of achieving HbA1c <7.0% was significantly improved (5.10% at baseline vs. 11.22% with IDegAsp, P=0.012). No significant differences (before vs. after switching) were observed in body weight change, and total daily insulin dose. The rates of overall and severe hypoglycemia were similar in the two periods. CONCLUSION: In real-world clinical practice in Korea, the change of insulin regimen to IDegAsp was associated with an improvement in glycemic control without increase of hypoglycemia, supporting the use of IDegAsp for patients with T2DM uncontrolled with basal or premix insulin. FAU - Kang, Shinae AU - Kang S AD - Division of Endocrinology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea. FAU - Ahn, Yu-Bae AU - Ahn YB AD - Division of Endocrinology and Metabolism, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea. FAU - Oh, Tae Keun AU - Oh TK AD - Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea. FAU - Lee, Won-Young AU - Lee WY AD - Division of Endocrinology and Metabolism, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea. FAU - Chun, Sung Wan AU - Chun SW AD - Division of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan, Korea. FAU - Bae, Boram AU - Bae B AD - Novo Nordisk Pharma Korea Limited, Seoul, Korea. FAU - Dahaoui, Amine AU - Dahaoui A AD - Novo Nordisk Region Asia Pacific, Dubai, United Arab Emirates. FAU - Jeong, Jin Sook AU - Jeong JS AD - Novo Nordisk Pharma Korea Limited, Seoul, Korea. FAU - Jung, Sungeun AU - Jung S AD - Novo Nordisk Region Asia Pacific, Dubai, United Arab Emirates. FAU - Jang, Hak Chul AU - Jang HC AD - Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea. LA - eng SI - ClinicalTrials.gov/NCT04656106 PT - Journal Article DEP - 20240227 PL - Korea (South) TA - Diabetes Metab J JT - Diabetes & metabolism journal JID - 101556588 SB - IM OTO - NOTNLM OT - Databases, factual OT - Diabetes mellitus, type 2 OT - Glycemic control OT - Hypoglycemia OT - Insulin degludec, insulin aspart drug combination EDAT- 2024/02/27 06:45 MHDA- 2024/02/27 06:45 CRDT- 2024/02/27 02:46 PHST- 2023/08/24 00:00 [received] PHST- 2023/11/22 00:00 [accepted] PHST- 2024/02/27 06:45 [medline] PHST- 2024/02/27 06:45 [pubmed] PHST- 2024/02/27 02:46 [entrez] AID - dmj.2023.0297 [pii] AID - 10.4093/dmj.2023.0297 [doi] PST - aheadofprint SO - Diabetes Metab J. 2024 Feb 27. doi: 10.4093/dmj.2023.0297.