Gómez-Medina Ana M, Henao-Carillo Diana C, Villamil-Castañeda Lina P, Gómez-Quesada Yaline, Muñoz-Velandia Oscar M, Yepes Carlos A, Chaim Salma N, Pertuz-Noriega Carlos E, Aschner Pablo
Endocrinology Unit, Hospital Universitario San Ignacio, Pontificia Universidad Javeriana, Bogotá, Colombia.
Internal Medicine Department, Hospital Universitario San Ignacio, Pontificia Universidad Javeriana, Bogotá, Colombia.
Diabetologia. 2025 Sep;68(9):1899-1907. doi: 10.1007/s00125-025-06446-y. Epub 2025 Aug 4.
AIMS/OBJECTIVE: The aim of the study was to assess the safety profile (defined as the percentage of patients with at least one hypoglycaemic event [more than 15 min with glucose levels <3.0 mmol/l as documented by continuous glucose monitoring] in the first 4 weeks of follow-up) for insulin degludec/liraglutide (IDegLira) compared with multiple daily insulin injections (MDI) during the transition from hospital to an outpatient setting.
The study was an open-label, randomised, controlled clinical trial comparing IDegLira to MDI after hospital discharge in patients with type 2 diabetes. The study evaluated the percentage of patients with at least one hypoglycaemic event, the hypoglycaemia event density, the time in range (TIR 3.8-10 mmol/l), the time below range (TBR <3.0 or <3.8 mmol/l), and other glycaemic management metrics measured by continuous glucose monitoring.
Sixty-four patients were included in the analysis (32 in each group). They had a baseline HbA of 103 ± 11.6 mmol/mol (11.6 ± 1.7%) and age of 58 ± 12.4 years (means ± SD). The proportion of patients with at least one hypoglycaemic event (plasma glucose <3.0 mmol/l) was lower in the IDegLira group than in the MDI group (6.2% vs 31.3%; p<0.010), as was the hypoglycaemia event density (incidence rate ratio 15.2; 95% CI 6.2, 48.2; p<0.001), TBR <3.8 mmol/l (0.9% vs 2.9%; p=0.019) and TBR <3.0 mmol/l (0.6% vs 1.3%, p=0.008). The TIR 3.8-10 mmol/l was higher in the IDegLira group (80.6% vs 69.7%; p=0.008). The findings were consistent regardless of baseline HbA.
CONCLUSIONS/INTERPRETATION: IDegLira proved to be safer and more effective than MDI for individuals with type 2 diabetes who had suboptimal glycaemic control, aiding in their transition from hospital to outpatient care.
Clinicaltrials.gov NCT05767255 FUNDING: This research was funded by a grant from the Asociación Colombiana de Endocrinología, Diabetes y Metabolismo (ACE).
本研究旨在评估德谷胰岛素/利拉鲁肽（IDegLira）与多次皮下注射胰岛素（MDI）相比，在2型糖尿病患者从医院过渡到门诊治疗期间的安全性（定义为随访前4周内至少发生一次低血糖事件的患者百分比，连续血糖监测记录葡萄糖水平<3.0 mmol/L超过15分钟）。
本研究为开放标签、随机对照临床试验，比较2型糖尿病患者出院后IDegLira与MDI的疗效。研究评估了至少发生一次低血糖事件的患者百分比、低血糖事件密度、血糖达标时间（TIR 3.8 - 10 mmol/L）、血糖低于范围的时间（TBR <3.0或<3.8 mmol/L）以及通过连续血糖监测测量的其他血糖管理指标。
64例患者纳入分析（每组32例）。他们的基线糖化血红蛋白为103 ± 11.6 mmol/mol（11.6 ± 1.7%），年龄为58 ± 12.4岁（均值±标准差）。IDegLira组至少发生一次低血糖事件（血糖<3.0 mmol/L）的患者比例低于MDI组（6.2%对31.3%；p<0.010），低血糖事件密度（发病率比值15.2；95%置信区间6.2, 48.2；p<0.001）、TBR <3.8 mmol/L（0.9%对2.9%；p = 0.019）和TBR <3.0 mmol/L（0.6%对1.3%，p = 0.008）也较低。IDegLira组的TIR 3.8 - 10 mmol/L更高（80.6%对69.7%；p = 0.008）。无论基线糖化血红蛋白如何，研究结果均一致。
结论/解读：对于血糖控制不佳的2型糖尿病患者，IDegLira在从医院过渡到门诊治疗期间比MDI更安全有效。
Clinicaltrials.gov NCT05767255 资助：本研究由哥伦比亚内分泌、糖尿病和代谢协会（ACE）的一项赠款资助。
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