AMCR Institute, Escondido, California.
Department of Real World Evidence, Sanofi, Bridgewater, New Jersey.
Diabetes Obes Metab. 2019 Jul;21(7):1596-1605. doi: 10.1111/dom.13693. Epub 2019 Apr 5.
To compare HbA1c and hypoglycaemia in insulin-naïve patients with type 2 diabetes (T2D) who initiated insulin glargine 300 units/mL (Gla-300) or 100 units/mL (Gla-100).
This retrospective cohort study examined electronic medical records of insulin-naïve adults with T2D who initiated Gla-300 or Gla-100 during March 2015 through to December 2016 with active records for ≥12 months before and ≥6 months after initiation, and ≥1 valid HbA1c value during 6-month baseline and 90-180-day follow-up. Outcomes included HbA1c and hypoglycaemia. Cohorts were propensity score-matched (1:2) on baseline demographic and clinical characteristics. Sensitivity analyses were conducted using broader inclusion criteria.
The matched cohorts included 1004 Gla-300 and 2008 Gla-100 initiators (mean age 60.4 years; 53.2% male). During 6-month follow-up, Gla-300 versus Gla-100 initiators had a greater mean HbA1c decrease (-1.52 ± 2.08% vs. -1.30 ± 2.12%; P = 0.003) and more patients achieved HbA1c <7% (25.0% vs. 21.5%; P = 0.029) and <8% (55.0% vs. 49.2%; P = 0.002); and HbA1c <7% (21.9% vs. 17.4%; P = 0.003) and <8% (49.1% vs. 41.8%; P < 0.001) without hypoglycaemia. Gla-300 initiators were similarly or less likely to have any or inpatient/emergency department-associated hypoglycaemia during 3- and 6-month follow-up (e.g. any hypoglycaemia to 6 months: 9.7% vs. 12.5%; adjusted odds ratio 0.61; P = 0.057).
Among insulin-naïve adults with T2D, Gla-300 was associated with significantly better HbA1c reductions (latest value during 90-180-day follow-up) and similar or improved hypoglycaemia outcomes (3- and 6-month follow-up) than Gla-100.
比较起始胰岛素甘精 300 单位/毫升（Gla-300）或 100 单位/毫升（Gla-100）治疗的 2 型糖尿病（T2D）胰岛素初治患者的糖化血红蛋白（HbA1c）和低血糖情况。
本回顾性队列研究纳入了 2015 年 3 月至 2016 年 12 月期间起始 Gla-300 或 Gla-100 的 T2D 胰岛素初治成年患者的电子病历，在起始前≥12 个月和起始后≥6 个月均有活跃记录，且在 6 个月基线期和 90-180 天随访期有≥1 次有效 HbA1c 值。主要结局包括 HbA1c 和低血糖。根据基线人口统计学和临床特征进行倾向评分匹配（1:2）。使用更广泛的纳入标准进行敏感性分析。
匹配的队列包括 1004 名 Gla-300 和 2008 名 Gla-100 起始者（平均年龄 60.4 岁；53.2%为男性）。在 6 个月随访期间，Gla-300 起始者的平均 HbA1c 降低幅度大于 Gla-100 起始者（-1.52±2.08% vs. -1.30±2.12%；P=0.003），且更多患者达到 HbA1c＜7%（25.0% vs. 21.5%；P=0.029）和＜8%（55.0% vs. 49.2%；P=0.002）；且 HbA1c＜7%（21.9% vs. 17.4%；P=0.003）和＜8%（49.1% vs. 41.8%；P＜0.001）且无低血糖。在 3 个月和 6 个月随访期间，Gla-300 起始者发生任何或住院/急诊部门相关低血糖的可能性相似或更低（例如，任何低血糖至 6 个月：9.7% vs. 12.5%；校正优势比 0.61；P=0.057）。
在 T2D 胰岛素初治成人患者中，与 Gla-100 相比，Gla-300 可显著降低 HbA1c（90-180 天随访期间的最新值），且低血糖结局相似或改善。
