Effect of once-weekly dulaglutide on glycated haemoglobin (HbA1c) and fasting blood glucose in patient subpopulations by gender, duration of diabetes and baseline HbA1c.
Effect of once-weekly dulaglutide on glycated haemoglobin (HbA1c) and fasting blood glucose in patient subpopulations by gender, duration of diabetes and baseline HbA1c.
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DOI：
10.1111/dom.13086
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发表时间：
2018-03
期刊：
影响因子：
--
通讯作者：
Giorgino F
中科院分区：
文献类型：
--
作者：
Gallwitz B;Dagogo-Jack S;Thieu V;Garcia-Perez LE;Pavo I;Yu M;Robertson KE;Zhang N;Giorgino F
在度拉鲁肽临床开发计划（AWARD‐1 至 ‐6 和 ‐8 临床试验）中，按性别、糖尿病病程和基线糖化血红蛋白 (HbA1c) 亚组评估度拉鲁肽 1.5 和 0.75 mg 对 2 型糖尿病患者的疗效和安全性。在汇总研究和个体研究中，根据性别、糖尿病病程（<5、≥5 年和 <10、≥10 年）和基线 HbA1c（<8.5%、≥8.5%）对 HbA1c 变化进行分析。个别试验评估了体重、低血糖和胃肠道不良事件相对基线的变化。在对 6 个月接受度拉糖肽 1.5mg 治疗的患者进行汇总分析时，不同性别的 HbA1c 相对于基线的降低程度相似（男性：最小二乘法 [LS] 平均值 -1.26% [95% 置信区间 {CI} -1.36, -1.16]；女性：LS 平均值 -1.33% [95% CI -1.43, -1.24]）以及糖尿病病程之间的差异亚组（<5岁：LS平均值-1.32％[95％CI -1.43，-1.22]；≥5岁和<10岁：LS平均值-1.33％[95％CI -1.43，-1.22]；≥10岁：-1.24％[95％CI -1.35，-1.14]）。基线 HbA1c ≥8.5% 的患者比基线 HbA1c <8.5% 的患者的 HbA1c 降低幅度更大（≥8.5%：LS 平均值 -1.86% [95% CI -1.97, -1.75]；<8.5%：LS 平均值 -1.02% [95% CI -1.12, -0.93]）。空腹血糖 (FBG) 的降低与 HbA1c 的变化一致。使用度拉鲁肽 0.75mg 观察到类似的结果。一般来说，糖尿病病程和基线 HbA1c 亚组的体重变化相似；服用两种度拉鲁肽剂量的女性比男性体重减轻更多或体重增加更少。不同性别或糖尿病病程的低血糖趋势没有临床意义的差异。除 AWARD-4 研究（与进餐时胰岛素联用）外，基线 HbA1c ≥8.5% 的患者低血糖发生率和发生率普遍低于 <8.5% 的患者。在所有 AWARD 研究中，无论性别、糖尿病病程或基线 HbA1c，度拉鲁肽都能显着改善血糖控制，基线 HbA1c 较高的患者的 HbA1c 和 FBG 降低幅度更大。度拉鲁肽具有良好的耐受性，其安全性与其他胰高血糖素样肽-1 受体激动剂相似。
To evaluate the efficacy and safety of dulaglutide 1.5 and 0.75 mg in patients with type 2 diabetes by subgroups of gender, duration of diabetes and baseline glycated haemoglobin (HbA1c) in the dulaglutide clinical development programme (AWARD‐1 to ‐6 and ‐8 clinical trials). Change in HbA1c was analysed by gender, duration of diabetes (<5, ≥5 years and <10, ≥10 years), and baseline HbA1c (<8.5%, ≥8.5%) in pooled and individual studies. Changes from baseline in weight, hypoglycaemia and gastrointestinal adverse events were evaluated for individual trials. In the pooled analysis of patients treated with dulaglutide 1.5 mg at 6 months, the reductions in HbA1c from baseline were similar across gender (men: least squares [LS] mean −1.26% [95% confidence interval {CI} −1.36, −1.16]; women: LS mean −1.33% [95% CI −1.43, −1.24]) and among duration of diabetes subgroups (<5 years: LS mean −1.32% [95% CI −1.43, −1.22]; ≥5 and <10 years: LS mean −1.33% [95% CI −1.43, −1.22]; ≥10 years: −1.24% [95% CI −1.35, −1.14]). Patients with baseline HbA1c ≥8.5% had greater HbA1c reductions than patients with baseline HbA1c <8.5%, (≥8.5%: LS mean −1.86% [95% CI −1.97, −1.75]; <8.5%: LS mean −1.02% [95% CI −1.12, −0.93]). Reductions in fasting blood glucose (FBG) were consistent with HbA1c changes. Similar results were observed with dulaglutide 0.75 mg. In general, body weight changes were similar among duration of diabetes and in baseline HbA1c subgroups, respectively; women had a numerically greater weight loss or less weight gain than men with both dulaglutide doses. There was no clinically meaningful difference in hypoglycaemia trends by gender or duration of diabetes. Hypoglycaemia incidence and rate were generally lower in patients with baseline HbA1c ≥8.5% than in those with <8.5%, except for the AWARD‐4 study (combination with mealtime insulin). Across the AWARD studies, dulaglutide demonstrated significant improvements in glycaemic control irrespective of gender, duration of diabetes, or baseline HbA1c, with greater HbA1c and FBG reductions in patients with a higher baseline HbA1c. Dulaglutide was well tolerated, with a safety profile similar to other glucagon‐like peptide‐1 receptor agonists.
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影响因子：
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发表时间：
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发表时间：
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影响因子：
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DOI：
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发表时间：
2016-05
期刊：
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