Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Division of Diabetes/Endocrinology/Lifestyle-related Disease, Takatsuki Red Cross Hospital, Takatsuki, Japan.
Diabetes Obes Metab. 2019 Dec;21(12):2694-2703. doi: 10.1111/dom.13859. Epub 2019 Sep 17.
To investigate the efficacy and safety of insulin degludec/liraglutide (IDegLira) compared with 50 U insulin degludec (degludec) or less in Japanese individuals with type 2 diabetes (T2D).
In this 26-week, double-blind, multicentre, treat-to-target trial, Japanese individuals with T2D that was uncontrolled with basal or pre-mix insulin (20-50 units) were randomized (1:1) to receive IDegLira or degludec, both with metformin. The maximum dose was 50 dose steps (IDegLira) or 50 units (degludec). The primary endpoint was change from baseline in HbA1c with IDegLira vs degludec after 26 weeks of treatment.
In total, 210 Japanese individuals were randomized to IDegLira or degludec and completion rates were 100% and 93%, respectively. IDegLira was superior to degludec with respect to change from baseline in HbA1c: estimated treatment difference (ETD) (95% confidence interval), -13.98 mmol/Mol (-16.41; -11.55); P < 0.0001. The change in mean HbA1c was from 70.6 by -21.3 mmol/Mol with IDegLira and from 70.1 by -7.1 mmol/Mol with degludec. Mean change in body weight was -0.7 kg with IDegLira and 0.7 kg with degludec: ETD (95% CI) -1.41 kg (-2.26; -0.56); P = 0.0012. Mean daily total insulin dose was significantly lower with IDegLira (37.6 U) as compared to that with degludec (41.2 U) at Week 26. Overall rates of severe or blood glucose-confirmed hypoglycaemia and adverse events were comparable between treatment groups.
IDegLira provided superior reductions in HbA1c compared with ≤50 U degludec, with weight loss and similar hypoglycaemia rates and no unexpected safety or tolerability issues. These results suggest that this treatment could be an attractive intensification option for Japanese subjects with T2D that was uncontrolled with basal or pre-mixed insulin.
评估德谷胰岛素/利拉鲁肽（IDegLira）与 50U 以下德谷胰岛素相比用于治疗未得到控制的日本 2 型糖尿病（T2D）患者的疗效和安全性。
这是一项为期 26 周的、双盲、多中心、针对目标的试验，入组的未得到控制的 T2D 日本患者正在接受基础或预混胰岛素（20-50U）治疗，将其随机（1:1）分配至接受 IDegLira 或德谷胰岛素治疗，同时联合使用二甲双胍。最大剂量为 50 个剂量单位（IDegLira）或 50U（德谷胰岛素）。主要终点为治疗 26 周后 IDegLira 与德谷胰岛素相比 HbA1c 的基线变化。
共有 210 名日本患者被随机分配至 IDegLira 或德谷胰岛素组，两组的完成率分别为 100%和 93%。IDegLira 与德谷胰岛素相比，在 HbA1c 方面的变化具有统计学优势：估计治疗差异（95%置信区间）为-13.98mmol/mol（-16.41；-11.55）；P<0.0001。IDegLira 组的平均 HbA1c 从基线的 70.6mmol/mol下降了-21.3mmol/mol，而德谷胰岛素组的平均 HbA1c 从基线的 70.1mmol/mol下降了-7.1mmol/mol。IDegLira 组的体重平均变化为-0.7kg，而德谷胰岛素组的体重平均变化为 0.7kg：差值（95%CI）为-1.41kg（-2.26；-0.56）；P=0.0012。在第 26 周时，IDegLira 的每日总胰岛素剂量明显低于德谷胰岛素（37.6U 比 41.2U）。严重低血糖或血糖确认的低血糖事件发生率和治疗组的不良反应发生率相似。
与≤50U 德谷胰岛素相比，IDegLira 可显著降低 HbA1c，同时降低体重且低血糖发生率相似，无意外安全性或耐受性问题。这些结果表明，对于未得到控制的基础或预混胰岛素治疗的 T2D 日本患者，这种治疗可能是一种有吸引力的强化治疗选择。
