Efficacy and safety of three-times-daily versus twice-daily biphasic insulin aspart 30 in patients with type 2 diabetes mellitus inadequately controlled with basal insulin combined with oral antidiabetic drugs
单位：[1]China–Japan Friendship Hospital, East Yinghuayuan Street, Hepingli, Beijing 100029, China[2]Division of Endocrinology and Metabolism, School of Medicine, Uludag University, Bursa, Turkey[3]Department of Endocrinology and Metabolism, The First Hospital of Jilin University, Changchun, Jilin Province 130021, China[4]School of Medicine, Shandong University, Jinan, Shandong, China[5]Department of Endocrinology, Anhui Provincial Hospital Affiliated to Anhui Medical University, Hefei, China[6]Department of Endocrinology, Shanghai Fifth People’s Hospital Affiliated to Fudan University, 801 Heqing Road, Minhang District, Shanghai 200240, China[7]The Second Affiliated Hospital of Nanjing Medical University, Nanjing, China[8]Department of Medicine, Government Medical College, Madurai, Tamil Nadu, India[9]Novo Nordisk A/S, Søborg, Denmark[10]Department of Medicine & Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China
Aims: To compare the efficacy and safety of biphasic insulin aspart 30 (BIAsp 30) administered three times daily (TID) vs. twice daily (BID), plus metformin, in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on basal insulin +/- 1 oral antidiabetic drug (OAD). Methods: Randomised, multinational, open-label, treat-to-target trial. Subjects inadequately controlled (HbA1c 7.5-10.0%) on basal insulin and metformin +/- 1 OAD were randomised to BIAsp 30 TID (n = 220) or BIAsp 30 BID (n = 217). Primary endpoint was change from baseline in HbA1c after 24 weeks of treatment. Results: Most (400/437, 91.5%) subjects completed the trial. The majority (276/400 [69.0%]) were from the China region. After 24 weeks, HbA1c decreased comparably in both BIAsp 30 groups (-1.7% vs. -1.6% [-19 vs. -18 mmol/mol], for TID and BID dosing, respectively; estimated treatment difference: -0.09% [-0.23; 0.06] 95% CI, -1 mmol/mol [-3; 1], p = 0.26). Safety profiles, including number of subjects experiencing hypoglycaemia, were similar. Conclusions: BIAsp 30 administered either TID or BID with metformin was a safe and effective option when intensifying treatment after failure of basal insulin and OADs in patients with T2DM. Adding a third injection at lunchtime may be preferable if HbA1c remains above target, if the lunchtime meal is the largest meal of the day, or if persistent postprandial hyperglycaemia after lunch is observed. (C) 2019 The Authors. Published by Elsevier B.V.
第一作者单位：[1]China–Japan Friendship Hospital, East Yinghuayuan Street, Hepingli, Beijing 100029, China
通讯作者：
推荐引用方式(GB/T 7714)：
Yang Wenying,Ersoy Canan,Wang Guixia,et al.Efficacy and safety of three-times-daily versus twice-daily biphasic insulin aspart 30 in patients with type 2 diabetes mellitus inadequately controlled with basal insulin combined with oral antidiabetic drugs[J].DIABETES RESEARCH and CLINICAL PRACTICE.2019,150:158-166.doi:10.1016/j.diabres.2019.02.023.
APA：
Yang, Wenying,Ersoy, Canan,Wang, Guixia,Ye, Shandong,Liu, Jun...&Chow, Francis.(2019).Efficacy and safety of three-times-daily versus twice-daily biphasic insulin aspart 30 in patients with type 2 diabetes mellitus inadequately controlled with basal insulin combined with oral antidiabetic drugs.DIABETES RESEARCH and CLINICAL PRACTICE,150,
MLA：
Yang, Wenying,et al."Efficacy and safety of three-times-daily versus twice-daily biphasic insulin aspart 30 in patients with type 2 diabetes mellitus inadequately controlled with basal insulin combined with oral antidiabetic drugs".DIABETES RESEARCH and CLINICAL PRACTICE 150.(2019):158-166
