Contribution of Liraglutide in the Fixed-Ratio Combination of Insulin Degludec and Liraglutide (IDegLira)
Contribution of Liraglutide in the Fixed-Ratio Combination of Insulin Degludec and Liraglutide (IDegLira)
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DOI：
10.2337/dc14-0785
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发表时间：
2014-11-01
期刊：
影响因子：
16.2
通讯作者：
Rodbard, Helena W.
中科院分区：
文献类型：
--
作者：
Buse, John B.;Vilsboll, Tina;Rodbard, Helena W.
德谷胰岛素/利拉鲁肽（IDegLira）是德谷胰岛素（IDeg）和利拉鲁肽的新型复方制剂。本试验研究了IDegLira中利拉鲁肽组分与单独使用IDeg相比对2型糖尿病患者的疗效和安全性的贡献。研究设计和方法在一项为期26周的双盲试验中，2型糖尿病患者（A1 C 7.5-10.0%[ 5886 mmol/mol]）接受基础胰岛素治疗（20-40单位）和二甲双胍联合或不联合磺酰脲类/格列奈类药物随机分配（1：1）每日一次IDegLira +二甲双胍或IDeg +二甲双胍，滴定目标为空腹血糖在4 - 5 mmol/L之间。最大允许剂量为50个剂量级（等于50单位IDeg加1.8 mg利拉鲁肽），IDeg为50单位。主要终点是A1 C相对于基线的变化。共有413名患者随机分组（平均A1 C 8.8% [73 mmol/mol]; BMI 33.7 kg/m2）。单独或作为IDegLira的一部分的IDeg剂量相当（45单位）。IDegLira组A1 C降低1.9%（21 mmol/mol），IDeg组降低0.9%（10 mmol/mol）（估计治疗差异-1.1% [95% CI-1.3，-0.8]，-12 mmol/mol [95% CI-14，-9; P < 0.0001）。IDegLira组的平均体重减轻为2.7 kg，而IDeg组无体重变化，P < 0.0001。低血糖发生率相当（IDegLira为24%，IDeg为25%）。总体不良事件相似，两组中恶心的发生率均较低（IDegLira 6.5% vs. IDeg 3.5%）。结论在同等胰岛素剂量下，Deg里拉实现的血糖控制上级优于IDeg，且无更高的低血糖风险，并具有体重减轻的获益。这些结果确定了IDegLira的疗效和安全性以及利拉鲁肽组分的独特贡献。
OBJECTIVEInsulin degludec/liraglutide (IDegLira) is a novel combination of insulin degludec (IDeg) and liraglutide. This trial investigated the contribution of the liraglutide component of IDegLira versus IDeg alone on efficacy and safety in patients with type 2 diabetes.RESEARCH DESIGN AND METHODSIn a 26-week, double-blind trial, patients with type 2 diabetes (A1C 7.5-10.0%[ 5886 mmol/mol]) on basal insulin (20-40 units) and metformin with or without sulfonylurea/glinides were randomized (1: 1) to once-daily IDegLira + metformin or IDeg + metformin with titration aiming for fasting plasma glucose between 4 and 5 mmol/L. Maximum allowed doseswere 50 dose steps (equal to 50 units IDeg plus 1.8 mg liraglutide) and 50 units for IDeg. The primary end point was change in A1C from baseline.RESULTSA total of 413 patients were randomized (mean A1C 8.8% [73 mmol/mol]; BMI 33.7 kg/m(2)). IDeg dose, alone or as part of IDegLira, was equivalent (45 units). A1C decreased by 1.9% (21 mmol/mol) with IDegLira and by 0.9% (10 mmol/mol) with IDeg (estimated treatment difference -1.1% [95% CI -1.3, -0.8], -12 mmol/mol [95% CI -14, -9; P < 0.0001). Mean weight reduction with IDegLira was 2.7 kg vs. no weight change with IDeg, P < 0.0001. Hypoglycemia incidence was comparable (24% for IDegLira vs. 25% for IDeg). Overall adverse events were similar, and incidence of nausea was low in both groups (IDegLira 6.5% vs. IDeg 3.5%).CONCLUSIONSIDegLira achieved glycemic control superior to that of IDeg at equivalent insulin doses without higher risk of hypoglycemia and with the benefit of weight loss. These findings establish the efficacy and safety of IDegLira and the distinct contribution of the liraglutide component.