Department of Medicine, NorthShore University HealthSystem/University of Chicago Pritzker School of Medicine, Evanston, IL, USA.
Novo Nordisk A/S, Søborg, Denmark.
J Diabetes Sci Technol. 2021 May;15(3):636-645. doi: 10.1177/1932296820906888. Epub 2020 Feb 28.
Insulin degludec/liraglutide (IDegLira) results in glycated hemoglobin (HbA1c) levels comparable with basal-bolus (BB) therapy. Here, we assessed the effect of once-daily IDegLira compared with BB (once-daily insulin glargine 100 U/mL and insulin aspart ≤4 times/day) across subgroups with varying characteristics.
DUAL VII trial participants (type 2 diabetes [T2D], HbA1c 53-86 mmol/mol [7.0%-10.0%]) were subgrouped post hoc based on the following baseline characteristics: HbA1c (≤58.5, >58.5 to ≤69.4, and >69.4 mmol/mol; ≤7.5%, >7.5 to ≤8.5%, and >8.5%), body mass index (<30, ≥30 to <35, and ≥35 kg/m), age (18 to <65 and ≥65 years), duration of diabetes (≥0 to 10 and ≥10 years), total pretrial daily basal insulin dose (20 to <30, ≥30 to <40, and ≥40 to ≤50 U), and fasting plasma glucose (<7.2 mmol/L/<130 mg/dL and ≥7.2 mmol/L/≥130 mg/dL).
Compared with BB, and in all subgroups, IDegLira treatment consistently gave similar HbA1c reductions, less severe or blood glucose-confirmed hypoglycemia, lower end-of-trial (EOT) total daily insulin dose, and weight loss. In all subgroups, mean EOT HbA1c was ≤53 mmol/mol (≤7.0%). The greatest HbA1c reduction occurred in the highest baseline HbA1c subgroup. Overall, mean EOT daily insulin dose was 0.43 to 0.52 U/kg with IDegLira and 0.74 to 1.07 U/kg with BB. More participants achieved the triple composite endpoint (HbA1c <53 mmol/mol [<7.0%] without weight gain or hypoglycemia) with IDegLira vs BB across the baseline HbA1c subgroups (≤58.5 mmol/mol [44.6% vs 7.0%], >58.5 to ≤69.4 mmol/mol [41.1% vs 8.3%], and >69.4 mmol/mol [23.8% vs 3.4%]).
These results support initiating IDegLira in patients with varying baseline characteristics and uncontrolled T2D on basal insulin.
CLINICALTRIALS.GOV REGISTRATION: NCT02420262.
德谷胰岛素/利拉鲁肽（IDegLira）可使糖化血红蛋白（HbA1c）水平与基础-餐时胰岛素方案（BB）相当。在此，我们评估了每日一次 IDegLira 相较于 BB（每日一次甘精胰岛素 100U/mL 和门冬胰岛素≤4 次/天）在具有不同特征的亚组中的疗效。
在 DUAL VII 试验中，根据以下基线特征对参与者进行了事后亚组分析：HbA1c（≤58.5、>58.5 至≤69.4 和>69.4mmol/mol；≤7.0%、>7.0 至≤8.5%和>8.5%）、体重指数（<30、≥30 至<35 和≥35kg/m2）、年龄（18 岁至<65 岁和≥65 岁）、糖尿病病程（≥0 年至<10 年和≥10 年）、总预试验期间每日基础胰岛素剂量（20 至<30、≥30 至<40 和≥40 至≤50U）和空腹血糖（<7.2mmol/L/<130mg/dL 和≥7.2mmol/L/≥130mg/dL）。
与 BB 相比，在所有亚组中，IDegLira 治疗均能持续降低 HbA1c，低血糖的严重程度或经证实的血糖水平更低，试验结束时（EOT）的总日胰岛素剂量更低，体重减轻。在所有亚组中，EOT 平均 HbA1c 均≤53mmol/mol（≤7.0%）。HbA1c 降幅最大的是基线 HbA1c 最高的亚组。总体而言，EOT 时 IDegLira 组的平均每日胰岛素剂量为 0.43 至 0.52U/kg，而 BB 组为 0.74 至 1.07U/kg。与 BB 相比，在所有 HbA1c 亚组中（≤58.5mmol/mol[44.6% vs 7.0%]、>58.5 至≤69.4mmol/mol[41.1% vs 8.3%]和>69.4mmol/mol[23.8% vs 3.4%]），更多患者使用 IDegLira 实现了三重复合终点（HbA1c<53mmol/mol[44.6% vs 7.0%]且无体重增加或低血糖）。
这些结果支持在基础胰岛素治疗控制不佳的 T2D 患者中起始 IDegLira 治疗。
NCT02420262。
