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Efficacy and safety of insulin degludec/insulin aspart versus biphasic insulin aspart 30 in Chinese adults with type 2 diabetes: A phase III, open-label, 2:1 randomized, treat-to-target trial

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单位: [1]China-Japan Friendship Hospital, Beijing, China [2]Nanjing First Hospital, Nanjing, China [3]Peking University Third Hospital, Beijing, China [4]Tianjin Medical University General Hospital, Tianjin, China [5]Second Affiliated Hospital of Nanjing Medical University, Nanjing, China [6]Shanghai First People's Hospital, Shanghai, China [7]First Affiliated Hospital of Anhui Medical University, Hefei, China [8]Fuzhou General Hospital of Nanjing Military Command, Fuzhou, China [9]Jiangsu Province Hospital, Jiangsu, China [10]Medical & Science Degludec Portfolio, Novo Nordisk A/S, Søborg, Denmark [11]Novo Nordisk (China) Pharmaceuticals Co. Ltd, Beijing, China [12]Peking Union Medical College Hospital, Beijing, China
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关键词: biphasic insulin aspart insulin aspart insulin degludec insulin treatment intensive insulin therapy type 2 diabetes

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Aims To assess the efficacy and safety of twice-daily insulin degludec/insulin aspart (IDegAsp) versus biphasic insulin aspart 30 (BIAsp 30) twice daily, both +/- metformin, in Chinese adults (N = 543) with type 2 diabetes (T2D) inadequately controlled on premixed/self-mixed or basal insulin +/- metformin. Materials and methods We conducted a 26-week, phase III, open-label, treat-to-target, 2:1 randomized trial. Hierarchical testing was used with non-inferiority of glycated haemoglobin (HbA1c) change from baseline to week 26 as the primary endpoint and superiority for the confirmatory secondary endpoints which were as follows: change from baseline in fasting plasma glucose (FPG); nocturnal confirmed hypoglycaemic episodes (12:01-5:59 am, inclusive); total confirmed hypoglycaemic episodes (severe or plasma glucose <3.1 mmol/L with/without symptoms); body weight; and percentage of responders (HbA1c <53 mmol/mol [<7.0%]) without confirmed hypoglycaemic episodes. Results Non-inferiority for change from baseline to week 26 in HbA1c and superiority of IDegAsp twice daily versus BIAsp 30 twice daily for change in FPG, nocturnal confirmed and total confirmed hypoglycaemic episodes, was demonstrated. Estimated rates of nocturnal confirmed and total confirmed hypoglycaemic episodes were 47% and 43% lower, respectively, with IDegAsp twice daily versus BIAsp 30 twice daily. Superiority for change in body weight was not confirmed. Participants were more likely to reach the HbA1c goal of <53 mmol/mol (<7.0%) without confirmed hypoglycaemia with IDegAsp twice daily versus BIAsp 30 twice daily by trial end. No new safety signals were identified. Conclusions The efficacy and safety of IDegAsp in Chinese patients with T2D was demonstrated, confirming results from international trials.

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出版当年[2018]版:
大类 | 1 区 医学
小类 | 1 区 内分泌学与代谢
最新[2025]版:
大类 | 2 区 医学
小类 | 2 区 内分泌学与代谢
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出版当年[2017]版:
Q1 ENDOCRINOLOGY & METABOLISM
最新[2023]版:
Q1 ENDOCRINOLOGY & METABOLISM

影响因子: 最新[2023版] 最新五年平均[2021-2025] 出版当年[2017版] 出版当年五年平均[2013-2017] 出版前一年[2016版] 出版后一年[2018版]

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第一作者单位: [1]China-Japan Friendship Hospital, Beijing, China
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通讯机构: [10]Medical & Science Degludec Portfolio, Novo Nordisk A/S, Søborg, Denmark [*1]Novo Nordisk A/S, Novo Nordisk A/S, Vandtaarnsvej 114, 2860 Søborg, Denmark.
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