School of Public Health, Dow University of Health Sciences, Karachi, Pakistan.
Department of Medicine, Dow University of Health Sciences, Karachi, Pakistan.
Front Endocrinol (Lausanne). 2022 Aug 17;13:926633. doi: 10.3389/fendo.2022.926633. eCollection 2022.
Diabetes mellitus (DM) is a chronic disease that needs early management to prevent complications and premature mortality. Therefore, it is essential to select evidence-based drugs available to control diabetes and limit the progression to related complications. This study aimed to compare the efficacy and safety of empagliflozin and vildagliptin in people with type 2 DM.
This was an open-label, parallel randomized controlled trial (NCT05359432) conducted at two tertiary care hospitals in Karachi, Pakistan. After obtaining consent, participants were randomized into two groups. The first group was given empagliflozin (10 mg once or two times daily) with metformin, and the second group got vildagliptin (50 mg once or two times daily) with metformin. HbA1c, high-density lipoprotein (HDL) levels, systolic blood pressure, fasting blood glucose, and body weight were measured at the baseline and 24-week visits.
A total of 120 patients fulfilled the selection criteria and then underwent randomization to be placed into empagliflozin and vildagliptin groups. The mean change in HbA1c (-0.97% ± 0.68 for empagliflozin and -0.82% ± 1.57 for vildagliptin) was statistically similar in both groups (p-value = 0.980). No statistically significant difference was observed between the two groups for safety parameters such as eGFR (p = 0.46), serum ALT (p = 0.13), LDL (p = 0.23), total cholesterol (p = 0.49), and triglycerides (p = 0.49).
Results of the study highlight that vildagliptin and empagliflozin have a significant beneficial effect in reducing HbA1c, fasting blood glucose, systolic blood pressure, and weight of participants. Both drugs had no differences when compared on safety parameters.
糖尿病（DM）是一种慢性病，需要早期管理以预防并发症和过早死亡。因此，选择现有的循证药物来控制糖尿病并限制其向相关并发症发展至关重要。本研究旨在比较恩格列净和维格列汀在 2 型糖尿病患者中的疗效和安全性。
这是一项在巴基斯坦卡拉奇的两家三级保健医院进行的开放标签、平行随机对照试验（NCT05359432）。在获得同意后，参与者被随机分为两组。第一组给予恩格列净（10 毫克，每日一次或两次）联合二甲双胍，第二组给予维格列汀（50 毫克，每日一次或两次）联合二甲双胍。在基线和 24 周访视时测量糖化血红蛋白（HbA1c）、高密度脂蛋白（HDL）水平、收缩压、空腹血糖和体重。
共有 120 名符合入选标准的患者接受了随机分组，分别进入恩格列净组和维格列汀组。两组的 HbA1c 平均变化（恩格列净组为-0.97%±0.68，维格列汀组为-0.82%±1.57）无统计学差异（p 值=0.980）。两组的安全性参数如 eGFR（p=0.46）、血清 ALT（p=0.13）、LDL（p=0.23）、总胆固醇（p=0.49）和甘油三酯（p=0.49）均无统计学差异。
研究结果表明，恩格列净和维格列汀均能显著降低 HbA1c、空腹血糖、收缩压和体重。在安全性参数方面，两种药物无差异。
