University Clinic of Endocrinology, Diabetes and Metabolic Disorders, Skopje, North Macedonia; Faculty of Medicine, Ss. Cyril and Methodius University in Skopje, 1000 Skopje, Republic of North Macedonia.
Novo Nordisk Farma Dooel, Skopje, North Macedonia.
Diabetes Res Clin Pract. 2023 Dec;206:111018. doi: 10.1016/j.diabres.2023.111018. Epub 2023 Nov 14.
The MIRAGE study aimed to evaluate the real-world use of once weekly (OW) subcutaneous semaglutide in glucagon-like peptide-1 receptor agonist naïve type 2 diabetes patients in routine clinical practice in North Macedonia.
MIRAGE was a multicentre, single-arm, retrospective and 30-weeks study, conducted in North Macedonia. Primary [change in glycated haemoglobin (HbA1c)] and secondary endpoints [change in body weight, fasting plasma glucose (FPG), lipid parameters, blood pressure, waist circumference, glycaemic and weight-loss target achievement] were evaluated between baseline and end of study (EOS).
Baseline characteristics of 314 patients enrolled in the study were, mean age: 55.5 years, HbA1c: 9.0 %, diabetes duration: 7.8 years, body weight: 105.2 kg and waist circumference: 114 cm. Patients at EOS experienced statistically significant estimated mean change in HbA1c: -2.2 % points, body weight: -9.0 kg, and FPG: -4.1 mmol/L (all p < 0.0001). At EOS, 62.1 % patients achieved HbA1c < 7 %, and 79.3 % had ≥ 1 % HbA1c reduction. A weight reduction of ≥ 3 % and ≥ 5 % was noted in 88.3 % and 73.3 % patients, respectively. No new safety concern has emerged.
Findings from MIRAGE study demonstrated glycaemic and weight-loss benefits of semaglutide, with improvements in other cardiometabolic parameters. The study supports real-world OW subcutaneous semaglutide use in North Macedonia.
MIRAGE 研究旨在评估每周一次(OW)皮下司美格鲁肽在北马其顿常规临床实践中对胰高血糖素样肽-1 受体激动剂初治 2 型糖尿病患者的实际应用。
MIRAGE 是一项多中心、单臂、回顾性的 30 周研究,在北马其顿进行。主要终点[糖化血红蛋白(HbA1c)的变化]和次要终点[体重、空腹血糖(FPG)、血脂参数、血压、腰围、血糖和减重目标的变化]在基线和研究结束时(EOS)进行评估。
纳入研究的 314 例患者的基线特征为:平均年龄 55.5 岁,HbA1c 9.0%,糖尿病病程 7.8 年,体重 105.2kg,腰围 114cm。患者在 EOS 时经历了 HbA1c 估计平均变化 -2.2%,体重-9.0kg,FPG-4.1mmol/L,所有差异均有统计学意义(均 p<0.0001)。在 EOS 时,62.1%的患者 HbA1c<7%,79.3%的患者 HbA1c 降低≥1%。88.3%和 73.3%的患者分别减轻体重≥3%和≥5%。没有出现新的安全性问题。
MIRAGE 研究结果表明,司美格鲁肽具有降糖和减重的益处,同时改善了其他心血管代谢参数。该研究支持北马其顿在实际应用中每周一次 OW 皮下注射司美格鲁肽。