OBJECTIVE In patients with uncontrolled type 2 diabetes on basal insulin, prandial insulin may be initiated. We assessed the efficacy and safety of initiating insulin degludec/liraglutide fixed-ratio combination (IDegLira) versus basal-bolus insulin. RESEARCH DESIGN AND METHODS A phase 3b trial examined patients with uncontrolled type 2 diabetes on insulin glargine (IGlar U100) 20–50 units/day and metformin, randomized to IDegLira or IGlar U100 and insulin aspart ≤4 times per day. RESULTS Glycated hemoglobin (HbA1c) decreased from 8.2% (66 mmol/mol) to 6.7% (50 mmol/mol) with IDegLira and from 8.2% (67 mmol/mol) to 6.7% (50 mmol/mol) with basal-bolus (estimated treatment difference [ETD] −0.02% [95% CI −0.16, 0.12]; −0.2 mmol/mol [95% CI −1.7, 1.3]), confirming IDegLira noninferiority versus basal-bolus ( P < 0.0001). The number of severe or blood glucose–confirmed symptomatic hypoglycemia events was lower with IDegLira versus basal-bolus (risk ratio 0.39 [95% CI 0.29, 0.51]; rate ratio 0.11 [95% CI 0.08, 0.17]). Body weight decreased with IDegLira and increased with basal-bolus (ETD −3.6 kg [95% CI −4.2, −2.9]). Fasting plasma glucose reductions were similar; lunch, dinner, and bedtime self-monitored plasma glucose measurements were significantly lower with basal-bolus. Sixty-six percent of patients on IDegLira vs. 67.0% on basal-bolus achieved HbA1c <7.0% (53 mmol/mol). Total daily insulin dose was lower with IDegLira (40 units) than basal-bolus (84 units total; 52 units basal). CONCLUSIONS In patients with uncontrolled type 2 diabetes on IGlar U100 and metformin, IDegLira treatment elicited HbA1c reductions comparable to basal-bolus, with statistically superior lower hypoglycemia rates and weight loss versus weight gain.

中文翻译：

---

IDegLira与基础-胰岛素治疗对二甲双胍和基础胰岛素不受控制的2型糖尿病患者的疗效和安全性：DUAL VII随机临床试验

目的对于基础胰岛素不受控制的2型糖尿病患者，可开始餐后胰岛素治疗。我们评估了起始胰岛素德格列地克/利拉鲁肽固定比例组合（IDegLira）与基础推注胰岛素的疗效和安全性。研究设计与方法一项3b期临床试验对患有不受控制的2型糖尿病的患者接受20–50单位/天的甘精胰岛素（IGlar U100）和二甲双胍治疗，随机分配给IDegLira或IGlar U100，门冬胰岛素≤4次。结果使用IDegLira的糖化血红蛋白（HbA1c）从8.2％（66 mmol / mol）降低到6.7％（50 mmol / mol），使用基础推注的糖化血红蛋白从8.2％（67 mmol / mol）降低到6.7％（50 mmol / mol） （估计的治疗差异[ETD] -0.02％[95％CI -0.16，0.12]; -0.2 mmol / mol [95％CI -1.7，1.3]），证实IDegLira的非劣效性与基础推注（P <0.0001）。IDegLira与基础推注相比，严重或血糖确诊的症状性低血糖事件的发生率更低（风险比0.39 [95％CI 0.29，0.51]；比率0.11 [95％CI 0.08，0.17]）。体重随着IDegLira而降低，并随着基础推注而增加（ETD -3.6 kg [95％CI -4.2，-2.9]）。空腹血糖降低相似。午餐，晚餐和就寝时间自我监测的血浆葡萄糖测量值与基础推注相比明显降低。使用IDegLira的患者中有66％的患者获得了HbA1c <7.0％（53 mmol / mol），而基础推注的患者为67.0％。IDegLira（40单位）的每日总胰岛素剂量低于基础推注（84单位；基础52单位）。结论在使用IGlar U100和二甲双胍治疗不受控制的2型糖尿病的患者中，IDegLira治疗可导致HbA1c的降低与基础推注相当，