Division of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Hospital, Soonchunhyang University College of Medicine, Seoul, Korea.
Department of Internal Medicine, Dongguk University Ilsan Hospital, Dongguk University School of Medicine, Goyang, Korea.
Diabetes Obes Metab. 2023 Sep;25(9):2743-2755. doi: 10.1111/dom.15164. Epub 2023 Jun 20.
To evaluate the effect of dapagliflozin on body composition such as total body fat (BF) mass, abdominal visceral adipose tissue (VAT), and subcutaneous adipose tissue (SAT) areas compared with glimepiride in Korean patients with type 2 diabetes.
This was a 52-week, multicentre, randomized, parallel-group, open-label, Phase IV (NCT02564926) study. Patients with inadequate glycaemic control (glycated haemoglobin ≥7.0% and <10.0%) on metformin monotherapy (≥1000 mg/day) were randomized 1:1 to receive dapagliflozin 10 mg/day or glimepiride 1-2 mg/day for 12 months as an add-on to metformin. Baseline and end of study body composition evaluations included dual-energy X-ray absorptiometry and abdominal computed tomography scans.
Of 124 enrolled patients from 14 centres, 121 received study treatment (dapagliflozin: 60; glimepiride: 61) and 106 (85.5%) completed the study. Over 52 weeks, the dapagliflozin group showed the following differences versus the glimepiride group: -2.59 kg BF mass, -1.94% BF%, -17.55 cm VAT area, -18.39 cm SAT area, -0.46% glycated haemoglobin, -18.25 mg/dl fasting blood glucose, -3.7 kg weight, -2.21 cm waist circumference, -1.37 kg/m body mass index, -6.81 mmHg systolic blood pressure and +657.71 ng/ml in adiponectin; all were statistically significant. Both groups had similar incidences of adverse events; however, hypoglycaemic events were mainly (12 of 15) reported in the glimepiride group.
Dapagliflozin reduced total BF mass, abdominal VAT and SAT areas, and showed better glycaemic control than glimepiride. Being safe and well-tolerated, dapagliflozin appears to be a more favourable alternative to sulphonylureas as add-on therapy after metformin monotherapy failure in Korean patients with type 2 diabetes.
评估达格列净相对于格列美脲对韩国 2 型糖尿病患者的体成分（如总体脂肪（BF）质量、腹部内脏脂肪组织（VAT）和皮下脂肪组织（SAT）面积）的影响。
这是一项为期 52 周、多中心、随机、平行分组、开放标签、IV 期（NCT02564926）研究。在接受二甲双胍单药治疗（≥1000mg/天）血糖控制仍不充分（糖化血红蛋白≥7.0%且<10.0%）的患者中，按 1:1 比例随机分为达格列净 10mg/天或格列美脲 1-2mg/天组，作为二甲双胍的附加治疗，共治疗 12 个月。基线和研究结束时的身体成分评估包括双能 X 射线吸收法和腹部计算机断层扫描。
在来自 14 个中心的 124 名入组患者中，121 名接受了研究治疗（达格列净：60 名；格列美脲：61 名），106 名（85.5%）完成了研究。在 52 周时，与格列美脲组相比，达格列净组的差异如下：-2.59kg BF 质量、-1.94% BF%、-17.55cm² VAT 面积、-18.39cm² SAT 面积、-0.46%糖化血红蛋白、-18.25mg/dl 空腹血糖、-3.7kg 体重、-2.21cm 腰围、-1.37kg/m² BMI、-6.81mmHg 收缩压和+657.71ng/ml 脂联素；所有差异均有统计学意义。两组不良事件发生率相似；然而，低血糖事件主要（15 例中有 12 例）发生在格列美脲组。
与格列美脲相比，达格列净降低了总体 BF 质量、腹部 VAT 和 SAT 面积，并改善了血糖控制。达格列净在安全性和耐受性方面表现良好，似乎是二甲双胍单药治疗失败后 2 型糖尿病韩国患者的磺脲类药物的更有利替代药物。
