Department of Endocrinology and Metabolism, Graduate School of Medicine, Yokohama City University, Yokohama, Japan.
Japan Community Health Care Organization, Yokohama Chuo Hospital, Yokohama, Japan.
J Diabetes Investig. 2020 Nov;11(6):1542-1550. doi: 10.1111/jdi.13270. Epub 2020 May 29.
AIMS/INTRODUCTION: Liraglutide and empagliflozin suppress cardiovascular events. However, reports on their long-term combined use with insulin therapy or direct comparisons of these drugs are limited.
This open-label, parallel-group, randomized controlled trial compared the effects of liraglutide and empagliflozin combined with insulin therapy in type 2 diabetes patients. Adult type 2 diabetes outpatients undergoing stable insulin therapy with glycated hemoglobin levels of 7.0-9.5% were enrolled. Participants received 0.9 mg/day liraglutide or 10 mg/day empagliflozin for 24 weeks. The primary end-point was the change in glycated hemoglobin levels from week 0 to 24. Body composition was assessed by dual-energy X-ray absorptiometry.
A total of 64 insulin-treated patients were randomized to receive liraglutide or empagliflozin. We analyzed 61 patients (30 liraglutide and 31 empagliflozin) who could be followed up. Liraglutide induced greater changes in glycated hemoglobin and glycated albumin than empagliflozin (glycated hemoglobin -1.24 ± 0.15% vs -0.35 ± 0.11%, P < 0.0001; glycated albumin -4.4 ± 0.6% vs -2.4 ± 0.5%, P < 0.01). Bodyweight (-1.3 ± 0.4 kg vs -1.5 ± 0.3 kg, P = 0.69) or body fat mass/lean tissue mass; urinary albumin excretion (median -5.3 mg/g-creatinine [interquartile range -60.6, 9.9 mg/g-creatinine] vs -12.9 mg/g-creatinine [interquartile range -70.8, -2.0 mg/g-creatinine], P = 0.23); and frequency of hypoglycemia did not differ significantly between the groups over a period of 24 weeks. There were no cases of study discontinuation owing to adverse effects.
Liraglutide addition to ongoing insulin therapy more effectively reduced glycated hemoglobin and glycated albumin levels than empagliflozin in patients with inadequately controlled type 2 diabetes.
目的/引言：利拉鲁肽和恩格列净可降低心血管事件风险。然而，关于它们与胰岛素治疗联合长期使用的报告或这些药物的直接比较有限。
这是一项开放标签、平行组、随机对照试验，比较了利拉鲁肽和恩格列净联合胰岛素治疗在 2 型糖尿病患者中的效果。入组患者为正在接受稳定胰岛素治疗、糖化血红蛋白水平为 7.0-9.5%的成年 2 型糖尿病门诊患者。参与者接受 0.9mg/天利拉鲁肽或 10mg/天恩格列净治疗 24 周。主要终点是从第 0 周到 24 周时糖化血红蛋白水平的变化。采用双能 X 射线吸收法评估身体成分。
共有 64 名接受胰岛素治疗的患者被随机分配接受利拉鲁肽或恩格列净治疗。我们分析了 61 名可随访的患者（利拉鲁肽组 30 名，恩格列净组 31 名）。与恩格列净相比，利拉鲁肽诱导的糖化血红蛋白和糖化白蛋白变化更大（糖化血红蛋白 -1.24±0.15% vs -0.35±0.11%，P<0.0001；糖化白蛋白 -4.4±0.6% vs -2.4±0.5%，P<0.01）。体重（-1.3±0.4kg vs -1.5±0.3kg，P=0.69）或体脂肪量/瘦体重；尿白蛋白排泄量（中位数 -5.3mg/g 肌酐[四分位距 -60.6，9.9mg/g 肌酐] vs -12.9mg/g 肌酐[四分位距 -70.8，-2.0mg/g 肌酐]，P=0.23）；以及低血糖的发生频率在 24 周内两组间无显著差异。无因不良反应而停药的病例。
与恩格列净相比，在血糖控制不佳的 2 型糖尿病患者中，利拉鲁肽联合胰岛素治疗更有效地降低糖化血红蛋白和糖化白蛋白水平。
