Dailey George, Reid Timothy, White John, Chao Jason, Zhou Fang L, Paranjape Sachin, Berhanu Paulos
Scripps Whittier Diabetes Institute San Diego California.
Mercyhealth Diabetes Center Janesville Wisconsin.
Endocrinol Diabetes Metab. 2018 Sep 21;1(4):e00035. doi: 10.1002/edm2.35. eCollection 2018 Oct.
Data from the EDITION 3 randomized study and the Clinformatics claims database were analysed to determine whether insulin glargine 300 U/mL (Gla-300) could provide insulin-naive patients with type 2 diabetes (T2D) on oral antidiabetes drugs (OADs) with reductions in prior OAD therapy without compromising glycaemic control, and while preserving its known low incidence of hypoglycaemia compared with insulin glargine 100 U/mL (Gla-100).
Patient-level data from EDITION 3 and de-identified data from the Clinformatics real-world claims database were analysed.
At baseline, 70% of patients in EDITION 3 were on a background of ≥2 OADs. Among the 435 and 437 patients who initiated basal insulin with Gla-300 and Gla-100, respectively, at Month 6, 336 (77%) and 338 (77%) were using ≤1 OAD. Adding Gla-300 or Gla-100 similarly allowed for a reduction in background OAD medication in the Clinformatics dataset (N = 6430), such that, at 6 months postbasal insulin initiation, 14% of patients were no longer taking any OADs. In the analysis of the EDITION 3 study, reduction in OAD burden did not compromise glycaemic benefit, and the low incidence of hypoglycaemia associated with Gla-300 compared with Gla-100 was also preserved. Documented symptomatic hypoglycaemia (blood glucose ≤70 mg/dL) occurred in 30.5% vs 41.0% of patients treated with Gla-300 and Gla-100, respectively (=0.0442).
Patients with T2D who initiate basal insulin with Gla-300 could potentially reduce their prior OAD use without compromising glycaemic control and with less hypoglycaemia than with Gla-100.
分析来自3期随机研究的数据和临床信息索赔数据库,以确定300 U/mL甘精胰岛素(Gla-300)能否为口服抗糖尿病药物(OAD)治疗的2型糖尿病(T2D)初治患者减少先前的OAD治疗,同时不影响血糖控制,并且与100 U/mL甘精胰岛素(Gla-100)相比,保持其已知的低血糖发生率较低的特点。
分析了3期研究的患者水平数据和临床信息真实世界索赔数据库的去识别数据。
在基线时,3期研究中70%的患者有≥2种OAD的用药背景。在分别使用Gla-300和Gla-100起始基础胰岛素治疗的435例和437例患者中,在第6个月时,分别有336例(77%)和338例(77%)使用≤1种OAD。在临床信息数据集(N = 6430)中,添加Gla-300或Gla-100同样能减少背景OAD用药,使得在起始基础胰岛素治疗6个月后,14%的患者不再服用任何OAD。在3期研究的分析中,OAD负担的减轻并未损害血糖获益,并且与Gla-100相比,Gla-300相关的低血糖发生率较低的特点也得以保持。记录到的有症状低血糖(血糖≤70 mg/dL)分别发生在接受Gla-300和Gla-100治疗患者中的比例为30.5%和41.0%(P = 0.0442)。
使用Gla-300起始基础胰岛素治疗的T2D患者可能减少先前的OAD使用,且不影响血糖控制,与使用Gla-100相比低血糖发生更少。