达帕格列净与基础胰岛素稳定三药联合疗法控制不佳的 2 型糖尿病患者血糖变化的有效性和安全性比较研究。

Q3 Medicine
Deepak S Bhosle, Bhakti Chandekar, Satish Shelke
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引用次数: 0

摘要

葡萄糖水平的广泛变化可能会增强氧化应激和炎症,从而导致内皮细胞损伤。甘精胰岛素,一种基础胰岛素,与良好的血糖控制和较少的低血糖事件有关。达格列净是一种选择性钠-葡萄糖共转运蛋白2 (SGLT-2)抑制剂,通过增强其尿排泄来降低血糖。连续血糖监测(CGM)可以持续评估间质血糖随时间的变化,从而实现糖尿病管理的个体化。目的:比较达格列净与基础胰岛素在稳定2型糖尿病(T2DM)患者血糖变异性(GV)中的疗效和安全性。材料和方法:在奥兰加巴德Deogiri糖尿病护理中心进行了一项为期1年的前瞻性、随机、开放标签、单中心、双臂、干预性临床研究。约100例三联用药控制不充分的T2DM患者随机分为A组(N = 50)和B组(N = 50), A组给予达格列净10 mg,每日1次(OD), B组给予甘精胰岛素作为第4种降糖药,为期3个月。本研究采用“FreeStyle Libre Pro®”动态血糖监测(AGM)传感器,评估GV系数、范围内时间(TIR)%、范围内时间(TBR)%、范围内时间(TAR)%和葡萄糖管理指数(GMI)。结果:治疗3个月后,两组患者的GV参数(TIR、TAR、TBR、GMI、GV系数)和血糖参数(空腹血糖(FBS)、餐后血糖(PPBS)、糖化血红蛋白(HbA1C)、体重变化均显著降低。结论:甘精胰岛素作为三联用药背景下的第四种降糖药物,与达格列净相比,已显示出GV的显著降低。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparative Study of Efficacy and Safety of Dapagliflozin vs Basal Insulin in Stabilizing Glycemic Variability in Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Triple Drug Combination Therapy.

Wide variations in glucose levels may enhance oxidative stress and inflammation, sequentially resulting in endothelial cell damage. Insulin glargine, a basal insulin, is associated with good glycemic control with fewer events of hypoglycemia. Dapagliflozin is a selective inhibitor of sodium-glucose cotransporter 2 (SGLT-2) that reduces blood glucose by enhancing its urinary excretion. Continuous glucose monitoring (CGM) allows continuous assessment of interstitial glucose over time, allowing individualization of diabetes management.

Objective: To compare the efficacy and safety of dapagliflozin vs basal insulin in stabilizing glycemic variability (GV) in patients with type 2 diabetes mellitus (T2DM).

Materials and methods: A 1-year, prospective, randomized, open-label, single-center, double-arm, interventional clinical study was conducted at Deogiri Diabetes Care Centre, Aurangabad. About 100 patients with T2DM who were inadequately controlled on triple drug combination therapy were randomized into group A (N = 50), receiving dapagliflozin 10 mg once daily (OD), and group B (N = 50), receiving insulin glargine as the fourth glucose-lowering agent for 3 months. The "FreeStyle Libre Pro®" ambulatory glucose monitoring (AGM) sensor was used for the study to evaluate the coefficient of GV, time in range (TIR)%, time below range (TBR)%, time above range (TAR)%, and glucose management index (GMI).

Results: A significant reduction in the values of GV parameters (TIR, TAR, TBR, GMI, and coefficient of GV) and glycemic parameters like fasting blood sugar (FBS), postprandial blood sugar (PPBS), glycated hemoglobin (HbA1C), and change in body weight of patients was observed in both groups after 3 months of therapy.

Conclusion: Insulin glargine, as the fourth glucose-lowering agent on the background of a triple drug regimen, has demonstrated a significant reduction in GV compared to that observed with dapagliflozin.

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