Department of Endocrinology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.
Department of Endocrinology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China
BMJ Open. 2024 Oct 11;14(10):e084834. doi: 10.1136/bmjopen-2024-084834.
The role of sodium-glucose cotransporter 2 inhibitors (SGLT2is) in diabetes treatment is expanding; however, few studies have investigated the efficacy and safety of combining SGLT2is with insulin pump therapy. Notably, there is a scarcity of high-quality, multicentre, clinical trials. Therefore, we aim to conduct a prospective multicentre, randomised, controlled, study to investigate whether treatment of type 2 diabetes patients with continuous subcutaneous insulin infusion (CSII) combined with henagliflozin can reduce the time required for blood glucose control, decrease total insulin requirements, mitigate blood glucose fluctuations and enhance beta-cell function.
In this inpatient, open-label, multicentre, randomised, controlled trial, 200 patients with type 2 diabetes who have not received hypoglycaemic drugs will be randomly allocated at a 1:1 ratio to either the henagliflozin combined with CSII group or the CSII group. The efficacy and safety of treatment in both groups will be compared. We will use a real-time continuous glucose monitoring system for blood glucose monitoring. The primary aim of this study is to compare the time (% time in range (TIR)) in the range of 3.9~10.0 mmol/L blood glucose between the two treatment groups. The secondary outcome measures will include comparisons of the two treatment groups with respect to the (a) time at TIR >70%; (b) mean amplitude of glycaemic excursions; (c) time below range; (d) total insulin dosage; and (e) time above range.
This study was approved by the Ethics Committee of the First Affiliated Hospital of Guangxi Medical University and is to be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. The study will be disseminated through peer-reviewed publications and conference presentations.
NCT05677334.
钠-葡萄糖共转运蛋白 2 抑制剂（SGLT2is）在糖尿病治疗中的作用正在扩大；然而，很少有研究调查 SGLT2is 与胰岛素泵治疗联合的疗效和安全性。值得注意的是，高质量、多中心的临床试验非常匮乏。因此，我们旨在开展一项前瞻性、多中心、随机、对照研究，以探讨 2 型糖尿病患者接受持续皮下胰岛素输注（CSII）联合亨格列净治疗是否能缩短血糖控制所需时间、减少总胰岛素需求、减轻血糖波动并增强β细胞功能。
在这项住院、开放标签、多中心、随机、对照试验中，将 200 名未接受过降糖药物治疗的 2 型糖尿病患者按照 1:1 的比例随机分配至亨格列净联合 CSII 组或 CSII 组。比较两组的治疗效果和安全性。我们将使用实时连续血糖监测系统进行血糖监测。本研究的主要目的是比较两组治疗后血糖在 3.9~10.0mmol/L 范围内的时间（%时间在范围内（TIR））。次要观察指标将包括比较两组治疗后（a）TIR>70%的时间；（b）血糖波动幅度的平均值；（c）血糖低于范围的时间；（d）总胰岛素剂量；和（e）血糖高于范围的时间。
这项研究已获得广西医科大学第一附属医院伦理委员会的批准，并将按照《赫尔辛基宣言》和《良好临床实践》进行。研究结果将通过同行评议的出版物和会议报告进行传播。
NCT05677334。
