AMCR Institute, Escondido, California, USA.
Sanofi, Bridgewater, New Jersey, USA.
Diabetes Obes Metab. 2022 Aug;24(8):1617-1622. doi: 10.1111/dom.14739. Epub 2022 May 26.
To provide real-world data on the addition of basal insulin (BI) in people with type 2 diabetes mellitus (PWD2) suboptimally controlled with glucagon-like peptide-1 receptor agonist (GLP-1RA) therapy. However, real-world data on the addition of BI to GLP-1RA therapy are limited.
We used a US electronic medical record data source (IBM® Explorys®) that includes approximately 4 million PWD2 to assess the real-world impact of adding the second-generation BI analogue insulin glargine 300 U/mL (Gla-300) to GLP-1RA therapy. Insulin-naïve PWD2 receiving GLP-1RAs who also received Gla-300 between March 1, 2015 and September 30, 2019 were identified; participants were required to have data for ≥12 months before, and ≥6 months after, addition of Gla-300.
The mean (standard deviation [SD]) age of participants (N = 271) was 57.9 (10.8) years. Baseline glycated haemoglobin (HbA1c) was 9.16% and was significantly reduced (-0.97 [SD 1.60]%; P < 0.0001) after addition of Gla-300; a significant increase in the proportion of PWD2 achieving HbA1c control was observed after addition of Gla-300 (HbA1c <7.0%: 4.80% vs. 22.14%, P < 0.0001; HbA1c <8.0%: 19.56% vs. 51.29%, P < 0.0001). The incidence of overall (8.49% vs. 9.59%; P = 0.513) and inpatient/emergency department (ED)-associated hypoglycaemia (0.37% vs. 0.74%; P = 1.000), as well as overall (0.33 vs. 0.46 per person per year [PPPY]; P = 0.170) and inpatient/ED-associated hypoglycaemia events (0.01 vs. 0.04 PPPY; P = 0.466) were similar before and after addition of Gla-300.
In US real-world clinical practice, adding Gla-300 to GLP-1RA significantly improved glycaemic control without significantly increasing hypoglycaemia in PWD2. Further research into the effect of adding Gla-300 to GLP-1RA therapy is warranted.
提供 2 型糖尿病(T2DM)患者在接受胰高血糖素样肽-1 受体激动剂(GLP-1RA)治疗控制不佳时添加基础胰岛素(BI)的真实世界数据。然而,关于在 GLP-1RA 治疗中添加 BI 的真实世界数据有限。
我们使用美国电子病历数据源(IBM®Explorys®),其中包括大约 400 万 T2DM 患者,评估在 GLP-1RA 治疗中添加第二代 BI 类似物胰岛素甘精 300U/mL(Gla-300)的真实世界影响。我们确定了 2015 年 3 月 1 日至 2019 年 9 月 30 日期间接受 GLP-1RA 治疗且同时接受 Gla-300 治疗的胰岛素初治 T2DM 患者;参与者在添加 Gla-300 之前必须有≥12 个月的数据,添加 Gla-300 之后必须有≥6 个月的数据。
271 名参与者的平均(标准差 [SD])年龄为 57.9(10.8)岁。基线糖化血红蛋白(HbA1c)为 9.16%,添加 Gla-300 后显著降低(-0.97[SD 1.60]%;P<0.0001);添加 Gla-300 后,HbA1c 控制达到的 T2DM 患者比例显著增加(HbA1c<7.0%:4.80%比 22.14%,P<0.0001;HbA1c<8.0%:19.56%比 51.29%,P<0.0001)。总体(8.49%比 9.59%;P=0.513)和住院/急诊部(ED)相关低血糖(0.37%比 0.74%;P=1.000)的发生率,以及总体(0.33 比 0.46 人年[PPPY];P=0.170)和住院/ED 相关低血糖事件(0.01 比 0.04 PPPY;P=0.466)在添加 Gla-300 前后相似。
在真实世界的美国临床实践中,在 GLP-1RA 治疗中添加 Gla-300 可显著改善血糖控制,而不会显著增加 T2DM 患者的低血糖。需要进一步研究在 GLP-1RA 治疗中添加 Gla-300 的效果。