Beneficial effects of once-daily lixisenatide on overall and postprandial glycemic levels without significant excess of hypoglycemia in Type 2 diabetes inadequately controlled on a sulfonylurea with or without metformin (GetGoal-S)
Beneficial effects of once-daily lixisenatide on overall and postprandial glycemic levels without significant excess of hypoglycemia in Type 2 diabetes inadequately controlled on a sulfonylurea with or without metformin (GetGoal-S)
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DOI：
10.1016/j.jdiacomp.2014.01.012
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发表时间：
2014-05-01
影响因子：
3
通讯作者：
Ratner, Robert E.
中科院分区：
文献类型：
--
作者：
Rosenstock, Julio;Hanefeld, Markolf;Ratner, Robert E.
目的：评估利司那肽每日一次与安慰剂相比在磺酰脲类药物+/- metformin.Methods控制不佳的2型糖尿病（T2 DM）患者中的疗效和安全性：在这项随机、双盲、双臂、平行组、多中心研究中，患者在磺酰脲类药物+/- metformin的基础上接受利司那肽20 μ g每日一次或安慰剂，持续24周，剂量逐步增加。结果：与安慰剂组相比，利格列汀组在第24周时HbA（1c）显著降低（LS均值：-0.85% vs. -0.10%; p < 0.0001），更多患者达到HbA（1c）< 7.0%（36.4% vs. 13.5%; p < 0.0001）。与安慰剂相比，利多卡因显著降低FPG和体重。在早餐试验患者中，与安慰剂相比，利司那肽降低了2小时PPG（LS均值：-111.48 vs. -3.80 mg/dL [-6.19 vs. -0.21 mmol/L]; p < 0.0001）和血糖波动（-94.11 vs. + 6.24 mg/dL [-5.22 vs. + 0.35 mmol/L]），以及2小时胰高血糖素、胰岛素、胰岛素原和C肽降低。利司那肽组和安慰剂组的AE百分比分别为68.3%和61.1%; SAE分别为3.5%和5.6%。利司那肽与安慰剂相比没有显著增加症状性低血糖（分别为15.3%和12.3%）;利司那肽组报告了一例严重的低血糖发作。结论：每日一次利司那肽显著改善血糖控制，具有明显的餐后效应，24周内症状性/严重低血糖风险没有显著增加，体重减轻。(C)2014作者爱思唯尔公司出版
Aims: To assess efficacy and safety of lixisenatide once-daily versus placebo in Type 2 diabetes mellitus (T2DM) patients inadequately controlled on sulfonylurea (SU) +/- metformin.Methods: In this randomized, double-blind, two-arm, parallel-group, multicenter study, patients received lixisenatide 20 mu g once-daily or placebo for 24 weeks in a stepwise dose increase on top of SUs +/- metformin. Primary outcome was change in HbA(1c) from baseline to Week 24.Results: Lixisenatide provided a significant reduction in HbA(1c) at Week 24 versus placebo (LS mean: -0.85% vs. -0.10%; p < 0.0001) and more patients achieved HbA(1c) < 7.0% (36.4% vs. 13.5%; p < 0.0001). Lixisenatide significantly lowered FPG and body weight versus placebo. In breakfast meal test patients, lixisenatide reduced 2-hour PPG versus placebo (LS mean: -111.48 vs. -3.80 mg/dL [-6.19 vs. -0.21 mmol/L]; p < 0.0001) and glucose excursion (-94.11 vs. + 6.24 mg/dL [-5.22 vs. + 0.35 mmol/L]), and reduced 2-hour glucagon, insulin, proinsulin, and C-peptide. The percentage of AEs was 68.3% for lixisenatide and 61.1% for placebo; and for SAEs: 3.5% versus 5.6%, respectively. Lixisenatide did not significantly increase symptomatic hypoglycemia versus placebo (15.3% vs. 12.3%, respectively); one severe episode of hypoglycemia was reported with lixisenatide.Conclusions: Once-daily lixisenatide significantly improved glycemic control, with a pronounced postprandial effect, without significant increase in symptomatic/severe hypoglycemia risk and with weight loss over 24 weeks. (C) 2014 The Authors. Published by Elsevier Inc.