利西拉来，一种基础胰岛素联合二甲双胍血糖控制不佳的 2 型糖尿病患者的可滴定固定比例复方制剂：LixiLan-L 随机试验的疗效和安全性。
Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial.
机构信息
Medstar Health Research Institute, Hyattsville, MD
Dallas Diabetes Research Center at Medical City, Dallas, TX.
出版信息
Diabetes Care. 2016 Nov;39(11):1972-1980. doi: 10.2337/dc16-1495. Epub 2016 Sep 20.
OBJECTIVE
This study was conducted to demonstrate the efficacy and safety of LixiLan (iGlarLixi), a novel, titratable, fixed-ratio combination of insulin glargine (iGlar) (100 units) and lixisenatide, compared with iGlar in patients with type 2 diabetes inadequately controlled on basal insulin with or without up to two oral glucose-lowering agents.
RESEARCH DESIGN AND METHODS
After a 6-week run-in when iGlar was introduced and/or further titrated, and oral antidiabetic drugs other than metformin were stopped, 736 basal insulin-treated patients (mean diabetes duration 12 years, BMI 31 kg/m) were randomized 1:1 to open-label, once-daily iGlarLixi or iGlar, both titrated to fasting plasma glucose <100 mg/dL (<5.6 mmol/L) up to a maximum dose of 60 units/day. The primary outcome was change in HbA levels at 30 weeks.
RESULTS
HbA decreased from 8.5% (69 mmol/mol) to 8.1% (65 mmol/mol) during the run-in period. After randomization, iGlarLixi showed greater reductions in HbA from baseline compared with iGlar (-1.1% vs. -0.6%, P < 0.0001), reaching a mean final HbA of 6.9% (52 mmol/mol) compared with 7.5% (58 mmol/mol) for iGlar. HbA <7.0% (53 mmol/mol) was achieved in 55% of iGlarLixi patients compared with 30% on iGlar. Mean body weight decreased by 0.7 kg with iGlarLixi and increased by 0.7 kg with iGlar (1.4 kg difference, P < 0.0001). Documented symptomatic hypoglycemia (≤70 mg/dL) was comparable between groups. Mild gastrointestinal adverse effects were very low but more frequent with iGlarLixi.
CONCLUSIONS
Compared with iGlar, a substantially higher proportion of iGlarLixi-treated patients achieved glycemic targets with a beneficial effect on body weight, no additional risk of hypoglycemia, and low levels of gastrointestinal adverse effects in inadequately controlled, basal insulin-treated, long-standing type 2 diabetes.
目的
本研究旨在证明新型可滴定固定比例胰岛素组合制剂利西拉来（iGlarLixi）的疗效和安全性，该制剂由胰岛素甘精（iGlar）（100 单位）和利西那肽组成，与基础胰岛素治疗控制不佳的 2 型糖尿病患者（在使用或不使用两种以上口服降糖药的情况下）的 iGlar 相比。
研究设计和方法
在为期 6 周的导入期内，引入并（或）进一步滴定 iGlar，并停用除二甲双胍以外的其他口服降糖药后，736 名接受基础胰岛素治疗的患者（平均糖尿病病程 12 年，BMI 31 kg/m）以 1:1 的比例随机分为开放标签、每日一次的 iGlarLixi 或 iGlar，均滴定至空腹血糖<100 mg/dL（<5.6 mmol/L），最大剂量为 60 单位/天。主要结局为 30 周时 HbA 水平的变化。
结果
在导入期内，HbA 从 8.5%（69 mmol/mol）降至 8.1%（65 mmol/mol）。随机分组后，与 iGlar 相比，iGlarLixi 从基线时的 HbA 降低更大（-1.1%比-0.6%，P<0.0001），最终平均 HbA 达到 6.9%（52 mmol/mol），而 iGlar 为 7.5%（58 mmol/mol）。与 iGlar 相比，55%的 iGlarLixi 患者达到 HbA<7.0%（53 mmol/mol），而 iGlar 为 30%。与 iGlar 相比，iGlarLixi 体重平均减轻 0.7kg，iGlar 体重增加 0.7kg（差值 1.4kg，P<0.0001）。两组之间记录到的症状性低血糖（≤70mg/dL）相似。轻度胃肠道不良反应非常低，但 iGlarLixi 更为常见。
结论
与 iGlar 相比，接受 iGlarLixi 治疗的患者中有更大比例达到了血糖目标，对体重有有益影响，低血糖风险无增加，胃肠道不良反应发生率低，在基础胰岛素治疗控制不佳、长期 2 型糖尿病患者中效果良好。
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