甘精胰岛素300 U/ml与100 U/ml治疗中国2型糖尿病患者疗效和安全性的比较 |
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引用本文: | 纪立农,董晓林,李玲,袁国跃,鲁一兵,徐向进,毕艳,李延兵,张秋玲,林静娜,黄昀,张霞,商淑华,崔楠,尹慧秋.甘精胰岛素300 U/ml与100 U/ml治疗中国2型糖尿病患者疗效和安全性的比较[J].中华糖尿病杂志,2021(2):112-117. |
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作者姓名: | 纪立农 董晓林 李玲 袁国跃 鲁一兵 徐向进 毕艳 李延兵 张秋玲 林静娜 黄昀 张霞 商淑华 崔楠 尹慧秋 |
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作者单位: | 北京大学人民医院内分泌科;济南市中心医院内分泌科;中国医科大学附属盛京医院内分泌科;江苏大学附属医院内分泌代谢科;南京医科大学第二附属医院内分泌科;联勤保障部队第900医院(原南京军区福州总医院)内分泌代谢科;南京大学医学院附属鼓楼医院内分泌科;中山大学附属第一医院内分泌科;杭州师范大学附属医院内分泌科;天津市人民医院内分泌科;赛诺菲(中国)投资有限公司上海分公司 |
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摘 要: | 目的比较甘精胰岛素300 U/ml(Gla-300)与100 U/ml(Gla-100)治疗非胰岛素类降糖药血糖控制不佳中国T2DM患者的疗效和安全性。方法本研究为EDITION AP(NCT02855684)中国亚组分析,在这项开放标签、随机对照的临床试验中,非Ins类降糖药物血糖控制不佳的474例中国T2DM患者按2:1比例随机予Gla-300(n=315)或Gla-100(n=159)治疗,观察两组26周时的疗效和安全性指标。结果两组自基线至治疗26周时HbA1c降幅的最小二乘均值差为0.05%,达到非劣效性评估终点。26周治疗期间,Gla-300组发生至少1次重度和/或证实夜间低血糖患者比例低于Gla-100组(31.5%vs 42.0%,P=0.03)。两组其余疗效和安全性指标差异无统计学意义。结论Gla-300治疗26周降低HbA1c效果与Gla-100相似,发生夜间低血糖风险更低。
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关 键 词: | 糖尿病 2型 甘精胰岛素 降血糖药 低血糖症 |
Efficacy and safety of insulin glargine 300 U/ml versus insulin glargine 100 U/ml in Chinese patients with type 2 diabetes mellitus inadequately controlled with non-insulin antihyperglycemic drugs |
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Affiliation: | (Department of Endocrinology,Peking University People's Hospital,Beijing 100044,China) |
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Abstract: | Objective To compare the efficacy and safety of insulin glargine 300 U/ml(Gla-300)versus insulin glargine 100 U/ml(Gla-100) in insulin-naive Chinese adult patients with type 2 diabetes mellitus(T2DM).Methods EDITION AP(NCT02855684) was an open-label,randomized, active-controlled,26-week study.In this Chinese subgroup analysis, 474 insulin-naive Chinese mainland participants with T2DM inadequately controlled with non-insulin antihyperglycemic drugs were randomized(2:1) to Gla-300(n=315) or Gla-100(n=159) group.Results Non-inferiority of two groups in HbA1c reduction from baseline to week 26 was confirmed with least squares mean difference of 0.05%.During 26-week treatment,fewer patients reported≥1 nocturnal severe or confirmed hypoglycemia with Gla-300 than Gla-100(31.5%vs 42.0%, P=0.03).Other efficacy and safety profile endpoints were similar between groups.Conclusion Gla-300 is non-inferior to Gla-100 in reducing HbA1c over 26 weeks in insulin-naive Chinese patients with T2DM, with lower nocturnal hypoglycemia risk. |
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Keywords: | Diabetes mellitus type 2 Insulin glargine Hypoglycemic agents Hypoglycemia |
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