Sivalingam Suvanjaa, Wasehuus Victor Soendergaard, Rotbain Curovic Viktor, Blond Martin Baek, Hansen Tine W, Persson Frederik, Rossing Peter
Steno Diabetes Center Copenhagen, Herlev, Denmark.
Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Diabetes Obes Metab. 2024 Jan;26(1):54-64. doi: 10.1111/dom.15287. Epub 2023 Sep 18.
To investigate whether combined treatment with empagliflozin (a sodium-glucose cotransporter-2 inhibitor) and semaglutide (a glucagon-like peptide-1 receptor agonist) can reduce urinary albumin-creatinine ratio (UACR) compared to treatment with empagliflozin alone in individuals with type 2 diabetes (T2D) and albuminuria.
We conducted a randomized, placebo-controlled, double-blind, parallel study including 60 individuals with T2D and albuminuria. All participants initiated open-label empagliflozin 25 mg once daily, on top of renin-angiotensin system inhibition, in a run-in period of 26 weeks. Subsequently, participants were randomized to semaglutide or placebo 1 mg once weekly for 26 weeks. The primary endpoint was change in UACR. Secondary endpoints were change in: (i) measured glomerular filtration rate (GFR); (ii) 24-hour systolic blood pressure; (iii) glycated haemoglobin (HbA1c) level; (iv) body weight; and (v) plasma renin and aldosterone levels.
Addition of semaglutide to empagliflozin provided no additional change in UACR from randomization to end-of-treatment. The mean (95% confidence interval) difference in UACR was -22 (-44; 10)% (P = 0.15) between treatment groups. Neither GFR, 24-hour blood pressure, body weight, nor plasma renin activity was changed with semaglutide. HbA1c (-8 [-13; -3] mmol/mol; P = 0.003) and plasma aldosterone (-30 [-50; -3] pmol/L; P = 0.035) were reduced with semaglutide compared to placebo.
Semaglutide added to empagliflozin did not change UACR, measured GFR, 24-hour systolic blood pressure, body weight or plasma renin levels in individuals with T2D and albuminuria. Semaglutide improved glycaemic control and plasma aldosterone levels compared to placebo.
研究在2型糖尿病（T2D）和白蛋白尿患者中，与单独使用恩格列净治疗相比，恩格列净（一种钠-葡萄糖协同转运蛋白2抑制剂）和司美格鲁肽（一种胰高血糖素样肽1受体激动剂）联合治疗是否能降低尿白蛋白肌酐比值（UACR）。
我们进行了一项随机、安慰剂对照、双盲、平行研究，纳入60例T2D和白蛋白尿患者。在为期26周的导入期内，所有参与者在肾素-血管紧张素系统抑制治疗的基础上，开始每日一次开放标签服用25 mg恩格列净。随后，参与者被随机分为司美格鲁肽组或安慰剂组，每周一次，每次1 mg，共26周。主要终点是UACR的变化。次要终点包括：（i）测量的肾小球滤过率（GFR）变化；（ii）24小时收缩压变化；（iii）糖化血红蛋白（HbA1c）水平变化；（iv）体重变化；以及（v）血浆肾素和醛固酮水平变化。
从随机分组到治疗结束，在恩格列净基础上加用司美格鲁肽并未使UACR有额外变化。治疗组之间UACR的平均（95%置信区间）差异为-22（-44；10）%（P = 0.15）。司美格鲁肽对GFR、24小时血压、体重或血浆肾素活性均无影响。与安慰剂相比，司美格鲁肽使HbA1c（-8 [-13；-3] mmol/mol；P = 0.003）和血浆醛固酮（-30 [-50；-3] pmol/L；P = 0.035）降低。
在T2D和白蛋白尿患者中，恩格列净加用司美格鲁肽对UACR、测量的GFR、24小时收缩压、体重或血浆肾素水平无影响。与安慰剂相比，司美格鲁肽改善了血糖控制和血浆醛固酮水平。
