艾塞那肽与门冬胰岛素30治疗2型糖尿病血糖变异性的比较：一项随机对照试验的研究方案

Comparison of exenatide with biphasic insulin aspart 30 on glucose variability in type 2 diabetes: study protocol for a randomized controlled trial.

作者信息

Xu Shaoyong, Liu Xiangyang, Ming Jie, Ji Qiuhe

机构信息

Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, 169 Changle Road West, Xi'an, 710032, China.

出版信息

Trials. 2016 Mar 24;17:160. doi: 10.1186/s13063-016-1258-8.

DOI:10.1186/s13063-016-1258-8

PMID:27009108

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4806460/

Abstract

BACKGROUND

Apart from the mean level of glycemic control, the extent of glucose excursions is another important issue to consider in type 2 diabetes mellitus (T2DM) management. Studies have showed that fluctuations of glucose seem to have more deleterious effects than sustained hyperglycemia in the development of diabetic complications as acute glucose swings activate the oxidative stress. However, until now, no randomized controlled trials have been conducted with the primary aim to evaluate glycemic fluctuation in the comparison between twice-daily exenatide and other treatment paradigms (for example, biphasic insulin aspart 30).

METHODS/DESIGN: This multicenter, open-label, randomized, parallel trial includes a 1-week screening period and a 16-week treatment period. After the screening period, 150 patients with confirmed type 2 diabetes who are treated with stable, maximum-tolerated doses of metformin will be randomly assigned to one of two groups for antihyperglycemic therapies: exenatide and biphasic insulin aspart 30. The treatment with exenatide will be initiated at a low dose of 5 μg twice a day for 4 weeks and then titrated up to a standard dose of 10 ug twice a day until the completion of the study. The adjustment of insulin dose is instructed to achieve an optimal balance between glycemic control and the risk of hypoglycemia as dictated by clinical practice. The primary outcome is the absolute change of mean amplitude of glycemic excursion from baseline to week 16, which is calculated based on a real-time continuous glucose monitoring system (CGMS).

DISCUSSION

This is the first randomized controlled trial using a CGMS to evaluate glycemic fluctuation between twice-daily exenatide and insulin aspart 30, which will provide beneficial evidence of exenatide usage in patients with T2DM.

TRIAL REGISTRATION NUMBER

NCT02449603 . Date of registration: 11 May 2015.

摘要

背景

除血糖控制的平均水平外，血糖波动幅度是2型糖尿病（T2DM）管理中另一个需要考虑的重要问题。研究表明，在糖尿病并发症的发生发展过程中，血糖波动似乎比持续性高血糖具有更有害的影响，因为急性血糖波动会激活氧化应激。然而，迄今为止，尚未进行以评估每日两次艾塞那肽与其他治疗方案（例如，门冬胰岛素30）之间血糖波动为主要目的的随机对照试验。

方法/设计：这项多中心、开放标签、随机、平行试验包括1周的筛查期和16周的治疗期。筛查期结束后，150例确诊为2型糖尿病且正在接受稳定的最大耐受剂量二甲双胍治疗的患者将被随机分为两组，接受降糖治疗：艾塞那肽和门冬胰岛素30。艾塞那肽治疗从每日两次低剂量5μg开始，持续4周，然后滴定至每日两次标准剂量10μg，直至研究结束。胰岛素剂量的调整需根据临床实践，在血糖控制和低血糖风险之间实现最佳平衡。主要结局是从基线到第16周血糖波动幅度平均值的绝对变化，该变化基于实时连续血糖监测系统（CGMS）计算得出。