使用SGLT2抑制剂预防糖尿病动脉粥样硬化的乌托邦试验的原理、设计和基线特征：一项前瞻性、随机、开放标签、平行组比较研究。
Rationale, Design, and Baseline Characteristics of the Utopia Trial for Preventing Diabetic Atherosclerosis Using an SGLT2 Inhibitor: A Prospective, Randomized, Open-Label, Parallel-Group Comparative Study.
作者信息
Katakami Naoto, Mita Tomoya, Yoshii Hidenori, Shiraiwa Toshihiko, Yasuda Tetsuyuki, Okada Yosuke, Umayahara Yutaka, Kaneto Hideaki, Osonoi Takeshi, Yamamoto Tsunehiko, Kuribayashi Nobuichi, Maeda Kazuhisa, Yokoyama Hiroki, Kosugi Keisuke, Ohtoshi Kentaro, Hayashi Isao, Sumitani Satoru, Tsugawa Mamiko, Ohashi Makoto, Taki Hideki, Nakamura Tadashi, Kawashima Satoshi, Sato Yasunori, Watada Hirotaka, Shimomura Iichiro
机构信息
Department of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.
Department of Metabolism and Atherosclerosis, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.
出版信息
Diabetes Ther. 2017 Oct;8(5):999-1013. doi: 10.1007/s13300-017-0292-1. Epub 2017 Sep 1.
INTRODUCTION
Sodium-glucose co-transporter-2 (SGLT2) inhibitors are anti-diabetic agents that improve glycemic control with a low risk of hypoglycemia and ameliorate a variety of cardiovascular risk factors. The aim of the ongoing study described herein is to investigate the preventive effects of tofogliflozin, a potent and selective SGLT2 inhibitor, on the progression of atherosclerosis in subjects with type 2 diabetes (T2DM) using carotid intima-media thickness (IMT), an established marker of cardiovascular disease (CVD), as a marker.
METHODS
The Study of Using Tofogliflozin for Possible better Intervention against Atherosclerosis for type 2 diabetes patients (UTOPIA) trial is a prospective, randomized, open-label, blinded-endpoint, multicenter, and parallel-group comparative study. The aim was to recruit a total of 340 subjects with T2DM but no history of apparent CVD at 24 clinical sites and randomly allocate these to a tofogliflozin treatment group or a conventional treatment group using drugs other than SGLT2 inhibitors. As primary outcomes, changes in mean and maximum IMT of the common carotid artery during a 104-week treatment period will be measured by carotid echography. Secondary outcomes include changes in glycemic control, parameters related to β-cell function and diabetic nephropathy, the occurrence of CVD and adverse events, and biochemical measurements reflecting vascular function.
CONCLUSION
This is the first study to address the effects of SGLT2 inhibitors on the progression of carotid IMT in subjects with T2DM without a history of CVD. The results will be available in the very near future, and these findings are expected to provide clinical data that will be helpful in the prevention of diabetic atherosclerosis and subsequent CVD.
FUNDING
Kowa Co., Ltd.
CLINICAL TRIAL REGISTRATION
UMIN000017607.
引言
钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂是一类抗糖尿病药物，可改善血糖控制，低血糖风险低，并能改善多种心血管危险因素。本文所述正在进行的研究旨在以颈动脉内膜中层厚度（IMT）（一种已确立的心血管疾病（CVD）标志物）为指标，研究强效选择性SGLT2抑制剂托格列净对2型糖尿病（T2DM）患者动脉粥样硬化进展的预防作用。
方法
2型糖尿病患者使用托格列净进行动脉粥样硬化更佳干预研究（UTOPIA）试验是一项前瞻性、随机、开放标签、盲终点、多中心平行组对照研究。目标是在24个临床地点共招募340例无明显CVD病史的T2DM患者，并将他们随机分配至托格列净治疗组或使用非SGLT2抑制剂药物的传统治疗组。作为主要结局，将通过颈动脉超声检查测量104周治疗期内颈总动脉平均和最大IMT的变化。次要结局包括血糖控制的变化、与β细胞功能和糖尿病肾病相关的参数、CVD和不良事件的发生情况，以及反映血管功能的生化指标。
结论
这是第一项研究SGLT2抑制剂对无CVD病史的T2DM患者颈动脉IMT进展影响的研究。结果将在不久后公布，预计这些发现将提供有助于预防糖尿病性动脉粥样硬化及后续CVD的临床数据。
资助
兴和株式会社
临床试验注册号
UMIN000017607
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