Efficacy and Safety of IDegAsp in a Real-World Korean Population with Type 2 Diabetes Mellitus

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...

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Main Authors: Shinae Kang, Yu-Bae Ahn, Tae Keun Oh, Won-Young Lee, Sung Wan Chun, Boram Bae, Amine Dahaoui, Jin Sook Jeong, Sungeun Jung, Hak Chul Jang
Format: Article
Language:English
Published: Korean Diabetes Association 2024-09-01
Series:Diabetes & Metabolism Journal
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Online Access:http://www.e-dmj.org/upload/pdf/dmj-2023-0297.pdf
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author Shinae Kang
Yu-Bae Ahn
Tae Keun Oh
Won-Young Lee
Sung Wan Chun
Boram Bae
Amine Dahaoui
Jin Sook Jeong
Sungeun Jung
Hak Chul Jang
author_facet Shinae Kang
Yu-Bae Ahn
Tae Keun Oh
Won-Young Lee
Sung Wan Chun
Boram Bae
Amine Dahaoui
Jin Sook Jeong
Sungeun Jung
Hak Chul Jang
author_sort Shinae Kang
collection DOAJ
description 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.
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spelling doaj-art-6eb6797552ce4bcfb7a4a27b90c0bf052025-08-20T01:54:30ZengKorean Diabetes AssociationDiabetes & Metabolism Journal2233-60792233-60872024-09-0148592993610.4093/dmj.2023.02972827Efficacy and Safety of IDegAsp in a Real-World Korean Population with Type 2 Diabetes MellitusShinae Kang0Yu-Bae Ahn1Tae Keun Oh2Won-Young Lee3Sung Wan Chun4Boram Bae5Amine Dahaoui6Jin Sook Jeong7Sungeun Jung8Hak Chul Jang9 Division of Endocrinology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea Division of Endocrinology and Metabolism, Department of Internal Medicine, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea Division of Endocrinology and Metabolism, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea Division of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan, Korea Novo Nordisk Pharma Korea Limited, Seoul, Korea Novo Nordisk Region Asia Pacific, Dubai, United Arab Emirates Novo Nordisk Pharma Korea Limited, Seoul, Korea Novo Nordisk Region Asia Pacific, Dubai, United Arab Emirates Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, KoreaBackground 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.http://www.e-dmj.org/upload/pdf/dmj-2023-0297.pdfdatabases, factualdiabetes mellitus, type 2glycemic controlhypoglycemiainsulin degludec, insulin aspart drug combination
spellingShingle Shinae Kang
Yu-Bae Ahn
Tae Keun Oh
Won-Young Lee
Sung Wan Chun
Boram Bae
Amine Dahaoui
Jin Sook Jeong
Sungeun Jung
Hak Chul Jang
Efficacy and Safety of IDegAsp in a Real-World Korean Population with Type 2 Diabetes Mellitus
Diabetes & Metabolism Journal
databases, factual
diabetes mellitus, type 2
glycemic control
hypoglycemia
insulin degludec, insulin aspart drug combination
title Efficacy and Safety of IDegAsp in a Real-World Korean Population with Type 2 Diabetes Mellitus
title_full Efficacy and Safety of IDegAsp in a Real-World Korean Population with Type 2 Diabetes Mellitus
title_fullStr Efficacy and Safety of IDegAsp in a Real-World Korean Population with Type 2 Diabetes Mellitus
title_full_unstemmed Efficacy and Safety of IDegAsp in a Real-World Korean Population with Type 2 Diabetes Mellitus
title_short Efficacy and Safety of IDegAsp in a Real-World Korean Population with Type 2 Diabetes Mellitus
title_sort efficacy and safety of idegasp in a real world korean population with type 2 diabetes mellitus
topic databases, factual
diabetes mellitus, type 2
glycemic control
hypoglycemia
insulin degludec, insulin aspart drug combination
url http://www.e-dmj.org/upload/pdf/dmj-2023-0297.pdf
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