Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, GA.
Deartment of Biostatistics, Rollins School of Public Health, Emory University, Atlanta, GA.
Diabetes Care. 2023 Sep 1;46(9):1640-1645. doi: 10.2337/dc22-2426.
In participants with type 2 diabetes (T2D) and HbA1c >9.0-10.0%, guidelines recommend treatment with basal-bolus insulin.
This randomized trial compared the efficacy and safety of insulin degludec and liraglutide (IDegLira) and basal-bolus among participants with high HbA1c ≥9.0-15.0%, previously treated with 2 or 3 oral agents and/or basal insulin, allocated (1:1) to basal-bolus (n = 73) or IDegLira (n = 72). The primary end point was noninferiority (0.4%) in HbA1c reduction between groups.
Among 145 participants (HbA1c 10.8% ± 1.3), there was no statistically significant difference in HbA1c reduction (3.18% ± 2.29 vs. 3.00% ± 1.79, P = 0.65; estimated treatment difference (ETD) 0.18%, 95% CI -0.59, 0.94) between the IDegLira and basal-bolus groups. IDegLira resulted in significantly lower rates of hypoglycemia <70 mg/dL (26% vs. 48%, P = 0.008; odds ratio 0.39, 95% CI 0.19, 0.78), and less weight gain (1.24 ± 8.33 vs. 5.84 ± 6.18 kg, P = 0.001; ETD -4.60, 95% CI -7.33, -1.87).
In participants with T2D and HbA1c ≥9.0-15.0%, IDegLira resulted in similar HbA1c reduction, less hypoglycemia, and less weight gain compared with the basal-bolus regimen.
在糖化血红蛋白（HbA1c）＞9.0-10.0%的 2 型糖尿病（T2D）患者中，指南建议采用基础-餐时胰岛素治疗。
本随机试验比较了在糖化血红蛋白（HbA1c）≥9.0-15.0%、之前接受过 2 种或 3 种口服药物和/或基础胰岛素治疗的患者中，德谷胰岛素利拉鲁肽注射液（IDegLira）和基础-餐时胰岛素方案的疗效和安全性，这些患者按照 1:1 随机分配到基础-餐时胰岛素组（n=73）或 IDegLira 组（n=72）。主要终点是两组间糖化血红蛋白（HbA1c）降幅的非劣效性（0.4%）。
在 145 名参与者（HbA1c 为 10.8%±1.3%）中，两组间 HbA1c 降幅（3.18%±2.29 比 3.00%±1.79，P=0.65；估计治疗差值（ETD）为 0.18%，95%置信区间为-0.59，0.94）无统计学显著差异。IDegLira 组低血糖（＜70mg/dL）发生率显著低于基础-餐时胰岛素组（26%比 48%，P=0.008；比值比 0.39，95%置信区间 0.19，0.78），体重增加也更少（1.24±8.33kg 比 5.84±6.18kg，P=0.001；ETD -4.60，95%置信区间-7.33，-1.87）。
在 HbA1c≥9.0-15.0%的 T2D 患者中，与基础-餐时胰岛素方案相比，IDegLira 治疗可使 HbA1c 降幅相似，低血糖发生率更低，体重增加更少。
