Department of Medicine, University of Helsinki, and Minerva Foundation Institute for Medical Research, Helsinki, Finland
International Diabetes Center at Park Nicollet, Minneapolis, MN.
Diabetes Care. 2014 Dec;37(12):3235-43. doi: 10.2337/dc14-0990. Epub 2014 Sep 5.
To compare the efficacy and safety of new insulin glargine 300 units/mL (Gla-300) with glargine 100 units/mL (Gla-100) in people with type 2 diabetes using basal insulin (≥42 units/day) plus oral antihyperglycemic drugs (OADs).
EDITION 2 was a multicenter, open-label, two-arm study. Adults receiving basal insulin plus OADs were randomized to Gla-300 or Gla-100 once daily for 6 months. The primary end point was change in HbA1c. The main secondary end point was percentage of participants with one or more nocturnal confirmed (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycemic events from week 9 to month 6.
Randomized participants (n = 811) had a mean (SD) HbA₁c of 8.24% (0.82) and BMI of 34.8 kg/m(2) (6.4). Glycemic control improved similarly with both basal insulins; least squares mean (SD) reduction from baseline was -0.57% (0.09) for Gla-300 and -0.56% (0.09) for Gla-100 (mean difference -0.01% [95% CI -0.14 to 0.12]), with 10% higher dose of Gla-300. Less nocturnal confirmed (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycemia was observed with Gla-300 from week 9 to month 6 (relative risk 0.77 [95% CI 0.61-0.99]; P = 0.038) and during the first 8 weeks. Fewer nocturnal and any time (24 h) hypoglycemic events were reported during the entire 6-month period. Weight gain was lower with Gla-300 than with Gla-100 (P = 0.015). No between-treatment differences in safety parameters were identified.
Gla-300 was as effective as Gla-100 and associated with a lower risk of hypoglycemia during the night and at any time of the day.
比较新型胰岛素甘精胰岛素 300 单位/毫升（Gla-300）与甘精胰岛素 100 单位/毫升（Gla-100）在使用基础胰岛素（≥42 单位/天）加口服降糖药（OADs）的 2 型糖尿病患者中的疗效和安全性。
EDITION 2 是一项多中心、开放标签、双臂研究。接受基础胰岛素加 OAD 治疗的成年人被随机分为 Gla-300 或 Gla-100 组，每日一次，治疗 6 个月。主要终点是 HbA1c 的变化。主要次要终点是从第 9 周到第 6 个月，有一个或多个夜间确认（≤3.9mmol/L[≤70mg/dL]）或严重低血糖事件的参与者比例。
随机参与者（n=811）的平均（SD）HbA₁c 为 8.24%（0.82）和 BMI 为 34.8kg/m²（6.4）。两种基础胰岛素的血糖控制均有相似改善；Gla-300 的最小二乘均值（SD）从基线下降-0.57%（0.09），Gla-100 为-0.56%（0.09）（平均差异-0.01%[95%CI-0.14 至 0.12]），Gla-300 的剂量高 10%。从第 9 周到第 6 个月（相对风险 0.77[95%CI0.61-0.99]；P=0.038）和前 8 周，夜间确认（≤3.9mmol/L[≤70mg/dL]）或严重低血糖事件发生的次数较少。在整个 6 个月期间，夜间和任何时间（24 小时）低血糖事件报告的次数较少。Gla-300 治疗组体重增加低于 Gla-100 治疗组（P=0.015）。两种治疗方法在安全性参数方面无差异。
Gla-300 与 Gla-100 疗效相当，夜间和白天任何时候低血糖的风险较低。
