Peking University People's Hospital, China.
Drum Tower Hospital Affiliated to Nanjing University Medical School, China.
Diabetes Res Clin Pract. 2021 Jun;176:108848. doi: 10.1016/j.diabres.2021.108848. Epub 2021 May 1.
To evaluate efficacy and safety of Gla-300 with Gla-100 in a patient-level meta-analysis among large East Asian patients with type 2 diabetes mellitus (T2DM).
A patient level meta-analysis of three EDITION studies with similar design and endpoints were conducted over 6-months treatment period. The analysis included 547 patients treated with Gla-300 and 348 patients treated with Gla-100.
Over 6-month treatment period, mean change in HbA1c was similar for Gla-300 [Least square (LS) mean, (SE): -1.13 (0.05) % and Gla-100: -1.14 (0.05) %], showing non-inferiority of Gla-300 to Gla-100 (LS mean difference: 0.02%, 95% CI: -0.08 to 0.11). Gla-300 was associated with reduced risk of hypoglycemic event (confirmed ≤ 3.9 mmol/L or severe) vs Gla-100 at any time of day or at night (00:00-05:59 h). The event rates of hypoglycemia were consistently lower with Gla-300 than Gla-100. Severe hypoglycemia was rare in both treatment groups. Weight gain was minimal in both treatment groups.
Gla-300 provides comparable glycemic control to Gla-100 in East Asian patients with broad clinical spectrum of T2DM, with consistently less hypoglycemia at any time of the day and night.
在东亚 2 型糖尿病（T2DM）大患者人群中进行一项基于患者水平的荟萃分析，评估 Gla-300 联合 Gla-100 的疗效和安全性。
对三项具有相似设计和终点的 EDITION 研究进行基于患者水平的荟萃分析，治疗期为 6 个月。该分析纳入了 547 例接受 Gla-300 治疗的患者和 348 例接受 Gla-100 治疗的患者。
在 6 个月的治疗期间，Gla-300 [最小二乘（LS）均数，（SE）：-1.13（0.05）%]和 Gla-100 [LS 均数：-1.14（0.05）%]组的 HbA1c 均值变化相似，表明 Gla-300 与 Gla-100 相比具有非劣效性（LS 均数差值：0.02%，95%CI：-0.08 至 0.11）。Gla-300 与任何时间（包括夜间 00:00-05:59 时）的低血糖事件（确诊≤3.9mmol/L 或严重低血糖）风险降低相关。Gla-300 组的低血糖事件发生率始终低于 Gla-100 组。两组的严重低血糖均罕见。两组的体重增加均较少。
Gla-300 在东亚 T2DM 患者中提供了与 Gla-100 相当的血糖控制效果，在任何时间的日间和夜间均具有一致更低的低血糖风险。
