A 24-week study to evaluate the efficacy and safety of once-weekly dulaglutide added on to glimepiride in type 2 diabetes (AWARD-8).
A 24-week study to evaluate the efficacy and safety of once-weekly dulaglutide added on to glimepiride in type 2 diabetes (AWARD-8).
复制标题
DOI：
10.1111/dom.12634
复制
发表时间：
2016-05
期刊：
影响因子：
--
通讯作者：
Robertson KE
中科院分区：
文献类型：
--
作者：
Dungan KM;Weitgasser R;Perez Manghi F;Pintilei E;Fahrbach JL;Jiang HH;Shell J;Robertson KE
在接受格列美脲单药治疗的2型糖尿病（T2 D）患者中，评价每周一次dulcin 1.5 mg（一种长效胰高血糖素样肽-1受体激动剂）与安慰剂相比的安全性和疗效。这项III期、随机化（4：1;度冷丁：安慰剂）、双盲、安慰剂对照、24周研究比较了度冷丁1.5 mg每周一次与安慰剂在接受磺脲类药物治疗（≥半数最大剂量，稳定≥3个月）且血糖控制不佳[糖化血红蛋白（HbA 1c）≥7.5且≤9.5%（≥58 mmol/mol且≤80 mmol/mol）]的T2 D患者（N = 300）中的安全性和疗效。根据意向治疗进行分析。基线时，平均受试者年龄为58岁;平均HbA 1c为8.4%（68 mmol/mol），平均体重为85.5 kg。在第24周时，Dulcampin 1.5 mg在HbA 1c相对于基线的降低方面上级安慰剂，组间HbA 1c差异为−1.3% [95%置信区间（CI）−1.6，−1.0]或− 14 mmol/mol（95% CI −17，−11）; p < 0.001。与安慰剂组相比，度拉糖肽组中达到HbA 1c水平<7.0%（53 mmol/mol）的参与者比例更高（55.3% vs 18.9%; p < 0.001）。与安慰剂组相比，Dulcantine显著降低空腹血糖（组间差异为−1.86 mmol/l（95% CI −2.58，−1.14）或−33.54 mg/dl（95% CI −46.55，−20.53）; p < 0.001）。在dulcantine组中，体重较基线显著降低（p < 0.001）;组间差异不显著。dulcin 1.5 mg最常见的治疗后出现的不良事件为胃肠道：恶心（10.5%）、腹泻（8.4%）和打嗝（5.9%）。与安慰剂相比，度乐宁1.5 mg组的总低血糖发生率较高（分别为2.37和0.07起事件/受试者/年; p = 0.025）。未报告重度低血糖。每周一次的度冷丁1.5 mg与格列美脲单药治疗联合使用时具有有利的获益/风险特征。
To evaluate the safety and efficacy of once‐weekly dulaglutide 1.5 mg, a long‐acting glucagon‐like peptide‐1 receptor agonist, compared with placebo in patients with type 2 diabetes (T2D) on glimepiride monotherapy. This phase III, randomized (4 : 1; dulaglutide:placebo), double‐blind, placebo‐controlled, 24‐week study compared the safety and efficacy of once‐weekly dulaglutide 1.5 mg with placebo in sulphonylurea‐treated (≥half‐maximal dose, stable ≥3 months) patients (N = 300) with T2D and inadequate glycaemic control [glycated haemoglobin (HbA1c) ≥7.5 and ≤9.5% (≥58 mmol/mol and ≤80 mmol/mol)]. Analysis was carried out according to intention‐to‐treat. At baseline, the mean participant age was 58 years; mean HbA1c was 8.4% (68 mmol/mol) and mean weight was 85.5 kg. Dulaglutide 1.5 mg was superior to placebo at 24 weeks for HbA1c reduction from baseline with a between‐group HbA1c difference of −1.3% [95% confidence interval (CI) −1.6, −1.0] or ‐14 mmol/mol (95% CI −17, −11); p < 0.001. A greater proportion of participants in the dulaglutide group reached an HbA1c level of <7.0% (53 mmol/mol) compared with placebo (55.3% vs 18.9%; p < 0.001). Dulaglutide significantly decreased fasting serum glucose from baseline compared with placebo (between‐group difference −1.86 mmol/l (95% CI −2.58, −1.14) or −33.54 mg/dl (95% CI −46.55, −20.53); p < 0.001. Weight was decreased significantly from baseline in the dulaglutide group (p < 0.001); the between‐group difference was not significant. The most common treatment‐emergent adverse events for dulaglutide 1.5 mg were gastrointestinal: nausea (10.5%), diarrhoea (8.4%) and eructation (5.9%). Total hypoglycaemia was higher with dulaglutide 1.5 mg vs placebo (2.37 and 0.07 events/participant/year, respectively; p = 0.025). No severe hypoglycaemia was reported. Once‐weekly dulaglutide 1.5 mg had a favourable benefit/risk profile when added to glimepiride monotherapy.
登录
查看更多内容
影响因子：
8.3
作者：
Ferdinand, Keith C.;White, William B.;Geiger, Mary Jane
通讯作者：
Geiger, Mary Jane
影响因子：
5.8
作者：
Davis, Timothy M. E.;Peters, Kirsten E.;Davis, Wendy A.
通讯作者：
Davis, Wendy A.
影响因子：
16.2
作者：
Jensen, Troels M.;Saha, Kishore;Steinberg, William M.
通讯作者：
Steinberg, William M.
影响因子：
105.7
作者：
Stratton, IM;Adler, AI;Holman, RR
通讯作者：
Holman, RR
影响因子：
16.2
作者：
Nauck M;Weinstock RS;Umpierrez GE;Guerci B;Skrivanek Z;Milicevic Z
通讯作者：
Milicevic Z