CHU Strasbourg, Department of Diabetology, Strasbourg, Alsace, France.
CHU Strasbourg, Department of Nephrology, Strasbourg, Alsace, France.
Diabetes Obes Metab. 2020 Jun;22(6):978-987. doi: 10.1111/dom.13988. Epub 2020 Feb 25.
To evaluate the effect of adding the dipeptidyl-peptidase-4 inhibitor vildagliptin to insulin on the glycaemic control of patients with type 2 diabetes undergoing haemodialysis.
Overall, 65 insulin-treated patients with type 2 diabetes undergoing haemodialysis (HbA1c: 7.3% ± 1.1%; age: 70.5 ± 8.5 years) were randomized (1:1) either to receive vildagliptin 50 mg/day in addition to insulin (vildagliptin-insulin group) or to pursue their usual insulin regimen (insulin-only group). Continuous glucose monitoring (CGM) was performed for 48 ± 6 hours at baseline and at week 12. The primary study endpoint was change from baseline in mean interstitial glucose using CGM. The secondary endpoints included other CGM variables and glucose control markers.
After 12 weeks, a greater reduction in mean CGM glucose from baseline was observed in the vildagliptin-insulin group compared with the insulin-only group, although the between-treatment difference was not statistically significant (mean difference [CI 95%]: -0.96 mmol/L [-2.09; 0.18] vs. -0.29 mmol/L [-1.29; 0.76], P = 0.32). However, a significant decrease from baseline in HbA1c, glycated albumin and insulin daily doses was observed in the vildagliptin-insulin group versus the insulin-only group (-0.6% [-1.19; -0.1], P < 0.01), in the vildagliptin-insulin group versus no change in the insulin-only group (-130.6 μmol/L [-271; 10.7] vs. +36.2 μmol/L [-164.4; 236.9], P = 0.04 and - 5.9 IU/day [-1.8; 7.1] vs. +1.1 IU/day [-14.5; 16.6], P = 0.01, respectively). There was no significant difference in the percentage of time spent in hypoglycaemia using CGM, occurrence of severe hypoglycaemia or number of adverse events.
In this study, vildagliptin added to insulin improved glycaemic control with an associated insulin-sparing effect in patients with type 2 diabetes undergoing haemodialysis and was well tolerated.
评估二肽基肽酶-4 抑制剂维格列汀联合胰岛素对行血液透析的 2 型糖尿病患者血糖控制的影响。
共纳入 65 例接受胰岛素治疗的行血液透析的 2 型糖尿病患者（糖化血红蛋白：7.3%±1.1%；年龄：70.5±8.5 岁），按照 1:1 的比例随机分为维格列汀 50mg/天+胰岛素组（维格列汀+胰岛素组）或继续接受胰岛素治疗组（胰岛素组）。在基线和 12 周时分别行 48±6 小时的连续血糖监测（CGM）。主要研究终点为 CGM 检测的平均间质葡萄糖水平的变化。次要终点包括其他 CGM 变量和血糖控制标志物。
与胰岛素组相比，维格列汀+胰岛素组治疗 12 周后 CGM 平均葡萄糖水平从基线显著降低，但两组间的差异无统计学意义（平均差值[CI 95%]：-0.96mmol/L[-2.09;0.18]vs.-0.29mmol/L[-1.29;0.76]，P=0.32）。然而，与胰岛素组相比，维格列汀+胰岛素组的糖化血红蛋白、糖基化白蛋白和胰岛素日剂量从基线显著降低（-0.6%[-1.19;0.01]，P<0.01），而胰岛素组无变化（-130.6μmol/L[-271;10.7]vs.+36.2μmol/L[-164.4;236.9]，P=0.04和-5.9IU/天[-1.8;7.1]vs.+1.1IU/天[-14.5;16.6]，P=0.01）。CGM 检测的低血糖时间百分比、严重低血糖发作率或不良事件数无显著差异。
在这项研究中，维格列汀联合胰岛素改善了行血液透析的 2 型糖尿病患者的血糖控制，且具有胰岛素节省作用，同时具有良好的耐受性。
