Kim Nam Hoon, Lim Soo, Jeong In-Kyung, Rhee Eun-Jung, Moon Jun Sung, Ryu Ohk-Hyun, Kwon Hyuk-Sang, Won Jong Chul, Kim Sang Soo, Kim Sang Yong, Ku Bon Jeong, Jin Heung Yong, Kim Sin Gon, Cha Bong-Soo
Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.
Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
Diabetes Metab J. 2025 Mar;49(2):225-234. doi: 10.4093/dmj.2024.0238. Epub 2025 Jan 6.
The novel sodium-glucose cotransporter-2 (SGLT2) inhibitor enavogliflozin effectively lowers glycosylated hemoglobin levels and body weights without the increased risk of serious adverse events; however, the long-term clinical benefits of enavogliflozin in terms of cardiovascular and renal outcomes have not been investigated.
This study is an investigator-initiated, multicenter, randomized, pragmatic, open-label, active-controlled, non-inferiority trial. Eligible participants are adults (aged ≥19 years) with type 2 diabetes mellitus (T2DM) who have a history of, or are at risk of, cardiovascular disease. A total of 2,862 participants will be randomly assigned to receive either enavogliflozin or other SGLT2 inhibitors with proven cardiorenal benefits, such as dapagliflozin or empagliflozin. The primary endpoint is the time to the first occurrence of a composite of major adverse cardiovascular or renal events (Clinical Research Information Service registration number: KCT0009243).
This trial will determine whether enavogliflozin is non-inferior to dapagliflozin or empagliflozin in terms of cardiorenal outcomes in patients with T2DM and cardiovascular risk factors. This study will elucidate the role of enavogliflozin in preventing vascular complications in patients with T2DM.
新型钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂依帕列净可有效降低糖化血红蛋白水平和体重，且不会增加严重不良事件的风险；然而，依帕列净在心血管和肾脏结局方面的长期临床益处尚未得到研究。
本研究是一项由研究者发起的、多中心、随机、实用、开放标签、活性对照、非劣效性试验。符合条件的参与者为患有2型糖尿病（T2DM）且有心血管疾病病史或有心血管疾病风险的成年人（年龄≥19岁）。共有2862名参与者将被随机分配接受依帕列净或其他已证实具有心脏肾脏益处的SGLT2抑制剂，如达格列净或恩格列净。主要终点是首次发生主要不良心血管或肾脏事件复合终点的时间（临床研究信息服务注册号：KCT0009243）。
本试验将确定在患有T2DM和心血管危险因素的患者中，依帕列净在心脏肾脏结局方面是否不劣于达格列净或恩格列净。本研究将阐明依帕列净在预防T2DM患者血管并发症中的作用。
