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%).

中文翻译：

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根据基线糖化血红蛋白 (HbA1c) 亚组，扩大剂量范围的度拉糖肽的血糖功效：AWARD-11 的事后分析

AWARD-11 试验证明了度拉糖肽 3.0 和 4.5 毫克与度拉糖肽 1.5 毫克相比，在二甲双胍控制不佳的 2 型糖尿病患者中的安全性和有效性。该事后分析检查了糖化血红蛋白 (HbA1c) 与基线相比的变化，以及在临床相关基线 HbA1c 亚组（<8%； 8.0% 至 < 9.0%；9.0% 至 < 10%；和 ≥ 10%）。在 36 周时观察到所有基线 HbA1c 亚组的 HbA1c 平均降低（HbA1c 变化范围：1.5 mg：-1.0% 至 -2.2%；3.0 mg：-1.2% 至 -2.5%；和 4.5 mg：-1.2% 至−3.2%)。更多患者随机分配至 3.0 毫克或 4.5 毫克（对比 1.5 毫克），在 36 周时实现 HbA1c <7%，而与基线 HbA1c 无关；P-交互作用 = 0.096）。在 52 周时观察到类似的血糖改善模式和 HbA1c <7% 的比例。HbA1c 亚组的低血糖和胃肠道不良事件相似。在基线 HbA1c 亚组（<8%；8.0% 到 <9.0%；9.0% 到 <10%；和 ≥ 10%）中，血糖控制随着度拉糖肽剂量从 1.5 mg 增加到 3.0 mg 或 4.5 mg 得到改善。