Arlington Family Health Pavilion, PA, Arlington, Texas.
Department of Medicine, Emory University, Atlanta, Georgia.
Diabetes Obes Metab. 2019 Nov;21(11):2465-2473. doi: 10.1111/dom.13829. Epub 2019 Aug 26.
To assess the addition of linagliptin as an alternative to insulin uptitration in older people with type 2 diabetes on stable insulin therapy.
This phase 4, randomized, multicentre, double-blinded, placebo-controlled, 24-week study recruited individuals on stable insulin, with baseline HbA1c 7.0%-10.0%, aged ≥60 years and body mass index ≤45 kg/m . HbA1c and fasting plasma glucose were measured at study visits, and participants assessed glycaemic control with a self-monitoring blood glucose device. Adverse events (AEs) were reported during the study.
Three hundred and two participants were randomized 1:1 to linagliptin 5 mg qd and placebo, with one third of patients from Japan. Study population age and HbA1c (baseline mean ± SD) were 72.4 ± 5.4 years and 8.2 ± 0.8%, respectively; ~80% of participants were aged ≥70 years; 80% had macrovascular complications, one third had a baseline estimated glomerular filtration rate <60 mL/min/1.73 m ; and half had been diagnosed with diabetes for >15 years. Linagliptin significantly improved glucose control at 24 weeks (HbA1c-adjusted mean change vs. placebo: -0.63%; P <0.0001) and the probability of achieving predefined HbA1c targets without hypoglycaemia (HbA1c <8.0%: OR 2.02; P <0.05 and HbA1c <7.0%: OR 2.44; P <0.01). Linagliptin versus placebo was well tolerated, with similar incidences of AEs, including clinically important hypoglycaemia (blood glucose <54 mg/dL) or severe hypoglycaemia.
Addition of linagliptin improves glucose control without an excess of hypoglycaemia in older patients with type 2 diabetes on stable insulin therapy.
评估在接受稳定胰岛素治疗的老年 2 型糖尿病患者中，加用利拉利汀替代胰岛素剂量调整。
这是一项 4 期、随机、多中心、双盲、安慰剂对照、24 周研究，纳入了基线糖化血红蛋白（HbA1c）为 7.0%-10.0%、年龄≥60 岁且体重指数（BMI）≤45kg/m 的接受稳定胰岛素治疗的患者。在研究访视时测量 HbA1c 和空腹血浆葡萄糖，参与者使用自我监测血糖设备评估血糖控制情况。在研究期间报告不良事件（AE）。
302 名患者被随机分为 1:1 接受利拉利汀 5mg 每日一次和安慰剂治疗，其中三分之一的患者来自日本。研究人群的年龄和 HbA1c（基线平均值±标准差）分别为 72.4±5.4 岁和 8.2±0.8%；约 80%的参与者年龄≥70 岁；80%有大血管并发症，三分之一的参与者基线估算肾小球滤过率（eGFR）<60mL/min/1.73m；并且一半的参与者糖尿病诊断时间超过 15 年。利拉利汀在 24 周时显著改善了血糖控制（与安慰剂相比，HbA1c 调整后的平均变化：-0.63%；P<0.0001），并且实现无低血糖情况下预定义的 HbA1c 目标的概率更高（HbA1c<8.0%：OR 2.02；P<0.05 和 HbA1c<7.0%：OR 2.44；P<0.01）。与安慰剂相比，利拉利汀具有良好的耐受性，AE 发生率相似，包括临床相关的低血糖（血糖<54mg/dL）或严重低血糖。
在接受稳定胰岛素治疗的老年 2 型糖尿病患者中，加用利拉利汀可改善血糖控制，而低血糖的发生风险没有增加。
