AIM 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. METHODS 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. RESULTS 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. CONCLUSION 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.

中文翻译：

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在血液透析的2型糖尿病患者中向胰岛素中添加维格列汀的效果：VILDDIAL研究是一项随机，多中心，前瞻性研究。

目的评估在胰岛素中添加二肽基-肽酶-4抑制剂维格列汀对接受血液透析的2型糖尿病患者血糖控制的作用。方法总体上，将65例接受胰岛素治疗的2型糖尿病血液透析患者（HbA1c：7.3％±1.1％;年龄：70.5±8.5岁）随机（1：1）接受除胰岛素以外的维达列汀50 mg /天（维格列汀-胰岛素组）或遵循他们通常的胰岛素治疗方案（仅胰岛素组）。在基线和第12周进行48±6小时的连续葡萄糖监测（CGM）。主要研究终点是使用CGM在平均间质葡萄糖水平上偏离基线。次要终点包括其他CGM变量和葡萄糖控制标志物。结果12周后，尽管治疗之间的差异无统计学意义（平均差异[CI 95％]：-0.96 mmol / L [ -2.09; 0.18]相对于-0.29 mmol / L [-1.29; 0.76]，P = 0.32）。然而，在维达列汀中，维达列汀胰岛素组的HbA1c，糖化白蛋白和胰岛素日剂量较基线水平显着降低（与仅胰岛素组相比，为-0.6％[-1.19; -0.1]，P <0.01）。 -胰岛素组与纯胰岛素组无变化（-130.6μmol/ L [-271; 10.7]与+36.2μmol/ L [-164.4; 236.9]，P = 0.04和-5.9 IU /天[-1.8 ; 7.1] vs. +1.1 IU /天[-14.5; 16.6]，P = 0.01）。使用CGM降低血糖的时间百分比没有显着差异，发生严重的低血糖症或不良事件的数量。结论在这项研究中，在接受血液透析的2型糖尿病患者中，将维达列汀添加到胰岛素中改善了血糖控制，并具有相关的降脂作用，并且耐受性良好。