Sang Hyunji, Kim Sunyoung, Hwang Jiyoung, Woo Selin, Kim Jaewon, Yon Dong Keon, Rhee Sang Youl
Department of Endocrinology and Metabolism, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea.
Center for Digital Health, Medical Science Research Institute, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea.
PLoS One. 2025 Jan 22;20(1):e0315603. doi: 10.1371/journal.pone.0315603. eCollection 2025.
Sodium-glucose co-transporter 2 inhibitors, such as enavogliflozin, offer promising metabolic benefits for patients with type 2 diabetes (T2D), including glycemic control and improved cardiac function. Despite the clinical evidence, real-world evidence is needed to validate their safety and effectiveness. This study aims to evaluate the effects of weight loss and safety of enavogliflozin administration in patients with T2D in a real-world clinical setting over 24 weeks. This is a large-scale, prospective, multicenter, non-interventional observational study and will be conducted in 12 primary care centers nationwide between 2024 and 2026. Data will be collected at baseline, 12 weeks, and 24 weeks in a real-world clinical setting, including demographic details, clinical history, lifestyle habits, medication use, and various health indicators. Eligible participants are adults aged 19 to 80 with T2D and a body mass index (BMI) of ≥23 kg/m2 who are currently receiving treatment with Envlo (enavogliflozin) or Envlomet (enavogliflozin/metformin) tablets or planning to start treatment. The primary outcome is the change in BMI and body weight at 24 weeks from baseline. Secondary outcomes evaluated are changes in BMI and weight at 12 weeks, the proportion of participants achieving significant reductions in BMI and weight at 12 and 24 weeks, and body composition and glycemic improvements at 12 and 24 weeks. The study will analyze shifts in lipid profiles, liver and kidney functions, and body composition at 12 and 24 weeks as exploratory outcomes. For safety outcomes, the trial will prioritize the monitoring of adverse drug reactions and specific events of interest such as hypoglycemia, urinary tract infections, genital infections, polyuria, and polydipsia. This study design enables us to evaluate the effectiveness and safety of enavogliflozin for weight loss in a real-world setting while exploring its potential positive effects on cardiac function and metabolic risk factors in overweight or obese patients with T2D.
钠-葡萄糖协同转运蛋白2抑制剂，如恩格列净，为2型糖尿病（T2D）患者带来了有前景的代谢益处，包括血糖控制和心脏功能改善。尽管有临床证据，但仍需要真实世界证据来验证其安全性和有效性。本研究旨在评估在真实世界临床环境中，恩格列净给药24周对T2D患者体重减轻的影响及其安全性。这是一项大规模、前瞻性、多中心、非干预性观察性研究，将于2024年至2026年在全国12个初级保健中心进行。将在真实世界临床环境中的基线、12周和24周收集数据，包括人口统计学细节、临床病史、生活习惯、药物使用情况以及各种健康指标。符合条件的参与者为年龄在19至80岁之间、患有T2D且体重指数（BMI）≥23 kg/m²的成年人，他们目前正在接受恩格列净片或恩格列净/二甲双胍片治疗或计划开始治疗。主要结局是24周时BMI和体重相对于基线的变化。评估的次要结局包括12周时BMI和体重的变化、12周和24周时BMI和体重显著降低的参与者比例，以及12周和24周时身体成分和血糖的改善情况。该研究将分析12周和24周时血脂谱、肝肾功能和身体成分的变化作为探索性结局。对于安全性结局，试验将优先监测药物不良反应以及低血糖、尿路感染、生殖器感染、多尿和烦渴等特定关注事件。本研究设计使我们能够在真实世界环境中评估恩格列净减肥的有效性和安全性，同时探索其对超重或肥胖T2D患者心脏功能和代谢危险因素的潜在积极影响。
