Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5).
Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5).
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DOI：
10.2337/dc13-2761
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发表时间：
2014-08
期刊：
影响因子：
16.2
通讯作者：
Milicevic Z
中科院分区：
文献类型：
--
作者：
Nauck M;Weinstock RS;Umpierrez GE;Guerci B;Skrivanek Z;Milicevic Z
比较两种剂量每周一次的度冷丁（一种胰高血糖素样肽1受体激动剂）与西格列汀在二甲双胍治疗的未控制的2型糖尿病患者中的疗效和安全性。主要目的是比较（非劣效性，然后是优效性）度拉糖肽1.5 mg与西格列汀在52周时糖基化血红蛋白A1 c（HbA 1c）较基线的变化。这项多中心、适应性、双盲、平行组研究将患者（N = 1，098;平均基线年龄54岁; HbA 1c 8.1% [65 mmol/mol];体重86.4 kg;糖尿病病程7年）随机分配至度乐汀1.5 mg、度乐汀0.75 mg、西格列汀100 mg或安慰剂组（安慰剂对照期长达26周）。治疗期持续104周，提供了52周的主要终点数据。第52周时HbA 1c的平均变化（最小二乘均值± SE）分别为：度乐宁1.5 mg、度乐宁0.75 mg和西格列汀组的−1.10 ± 0.06%（−12.0 ± 0.7 mmol/mol）、−0.87 ± 0.06%（9.5 ± 0.7 mmol/mol）和−0.39 ± 0.06%（4.3 ± 0.7 mmol/mol）。两种剂量的dulglutamine均上级西格列汀（P < 0.001，两种比较）。未报告重度低血糖事件。与西格列汀组（−1.53 ± 0.22 kg）相比，dullipin 1.5 mg组（−3.03 ± 0.22 kg）和dullipin 0.75 mg组（−2.60 ± 0.23 kg）至52周的平均体重变化更大（P < 0.001，两项比较）。在dulcine 1.5 mg和0.75 mg组中，最常见的胃肠道治疗后出现的不良事件为恶心、腹泻和呕吐。在52周时，两种剂量的度乐汀均显示出优于西格列汀的上级血糖控制，且耐受性和安全性特征可接受。
To compare the efficacy and safety of two doses of once-weekly dulaglutide, a glucagon-like peptide 1 receptor agonist, to sitagliptin in uncontrolled, metformin-treated patients with type 2 diabetes. The primary objective was to compare (for noninferiority and then superiority) dulaglutide 1.5 mg versus sitagliptin in change from baseline in glycosylated hemoglobin A1c (HbA1c) at 52 weeks. This multicenter, adaptive, double-blind, parallel-arm study randomized patients (N = 1,098; mean baseline age 54 years; HbA1c 8.1% [65 mmol/mol]; weight 86.4 kg; diabetes duration 7 years) to dulaglutide 1.5 mg, dulaglutide 0.75 mg, sitagliptin 100 mg, or placebo (placebo-controlled period up to 26 weeks). The treatment period lasted 104 weeks, with 52-week primary end point data presented. The mean HbA1c changes to 52 weeks were (least squares mean ± SE): −1.10 ± 0.06% (−12.0 ± 0.7 mmol/mol), −0.87 ± 0.06% (9.5 ± 0.7 mmol/mol), and −0.39 ± 0.06% (4.3 ± 0.7 mmol/mol) for dulaglutide 1.5 mg, dulaglutide 0.75 mg, and sitagliptin, respectively. Both dulaglutide doses were superior to sitagliptin (P < 0.001, both comparisons). No events of severe hypoglycemia were reported. Mean weight changes to 52 weeks were greater with dulaglutide 1.5 mg (−3.03 ± 0.22 kg) and dulaglutide 0.75 mg (−2.60 ± 0.23 kg) compared with sitagliptin (−1.53 ± 0.22 kg) (P < 0.001, both comparisons). The most common gastrointestinal treatment-emergent adverse events in dulaglutide 1.5- and 0.75-mg arms were nausea, diarrhea, and vomiting. Both dulaglutide doses demonstrated superior glycemic control versus sitagliptin at 52 weeks with an acceptable tolerability and safety profile.
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影响因子：
5.8
作者：
Barrington, P.;Chien, J. Y.;Hardy, T. A.
通讯作者：
Hardy, T. A.
影响因子：
2.3
作者：
DeFronzo, Ralph A.;Okerson, Ted;MacConell, Leigh
通讯作者：
MacConell, Leigh
影响因子：
16.2
作者：
Aschner, Pablo;Kipnes, Mark S.;Williams-Herman, Debora E.
通讯作者：
Williams-Herman, Debora E.
影响因子：
3.5
作者：
HOLST, JJ;ORSKOV, C;SCHWARTZ, TW
通讯作者：
SCHWARTZ, TW
影响因子：
6.1
作者：
Schellekens, H
通讯作者：
Schellekens, H