National Research Institute, Los Angeles, California, USA.
University and University Hospital of Verona, Verona, Italy.
Diabetes Obes Metab. 2021 Dec;23(12):2819-2824. doi: 10.1111/dom.14533. Epub 2021 Sep 14.
The AWARD-11 trial demonstrated the safety and efficacy of dulaglutide 3.0 and 4.5 mg compared to dulaglutide 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin. This post hoc analysis examined the change from baseline in glycated haemoglobin (HbA1c) and proportions of patients achieving HbA1c <7% at weeks 36 and 52 with dulaglutide 1.5 mg, 3.0 mg or 4.5 mg across clinically relevant baseline HbA1c subgroups (<8%; 8.0% to < 9.0%; 9.0% to < 10%; and ≥ 10%). Mean reductions in HbA1c were observed across all baseline HbA1c subgroups at 36 weeks (range of HbA1c change: 1.5 mg: -1.0% to -2.2%; 3.0 mg: -1.2% to -2.5%; and 4.5 mg: -1.2% to -3.2%). More patients randomized to 3.0 mg or 4.5 mg (vs. 1.5 mg) achieved HbA1c <7% at 36 weeks regardless of baseline HbA1c; the difference in proportions was greater at higher baseline HbA1c (P-interaction = 0.096). Similar patterns in glycaemic improvement and proportions achieving HbA1c <7% were observed at 52 weeks. Hypoglycaemia and gastrointestinal adverse events were similar among the HbA1c subgroups. Glycaemic control was improved with dulaglutide dose escalation from 1.5 mg to 3.0 mg or 4.5 mg across baseline HbA1c subgroups (<8%; 8.0% to < 9.0%; 9.0% to < 10%; and ≥ 10%).
AWARD-11 试验表明，与 1.5mg 相比，在二甲双胍控制不佳的 2 型糖尿病患者中，度拉鲁肽 3.0mg 和 4.5mg 具有安全性和疗效。这项事后分析检查了基线时糖化血红蛋白（HbA1c）的变化，以及在基线 HbA1c 相关亚组（<8%；8.0%至<9.0%；9.0%至<10%；≥10%）中，度拉鲁肽 1.5mg、3.0mg 或 4.5mg 在第 36 周和第 52 周时达到 HbA1c<7%的患者比例。在所有基线 HbA1c 亚组中，在第 36 周时观察到 HbA1c 的平均降低（HbA1c 变化范围：1.5mg：-1.0%至-2.2%；3.0mg：-1.2%至-2.5%；和 4.5mg：-1.2%至-3.2%）。与 1.5mg 相比，更多随机接受 3.0mg 或 4.5mg（与 1.5mg）的患者在第 36 周时达到 HbA1c<7%；在较高的基线 HbA1c 时，差异更大（P 交互作用=0.096）。在第 52 周时，也观察到类似的血糖改善模式和达到 HbA1c<7%的比例。在 HbA1c 亚组中，低血糖和胃肠道不良事件相似。在整个基线 HbA1c 亚组中，随着度拉鲁肽剂量从 1.5mg 增加到 3.0mg 或 4.5mg，血糖控制得到改善（<8%；8.0%至<9.0%；9.0%至<10%；和≥10%）。
