Malik Rayaz A, Anderson John, Russo Giuseppina, Amani Mohammed E A, Adaş Mine, Alvarez Agustina, Lauand Felipe, Li Xuan, Khunti Kamlesh
Research Division, Weill Cornell Medicine-Qatar, Qatar Foundation Education City, Ar-Rayyan, Qatar.
The Frist Clinic, Nashville, Tennessee, USA.
Diabetes Obes Metab. 2025 Oct;27(10):5487-5497. doi: 10.1111/dom.16591. Epub 2025 Aug 11.
To evaluate the effectiveness and safety of a fixed-ratio combination of insulin glargine 100 U/mL and lixisenatide (iGlarLixi) over 24 months in people with type 2 diabetes (T2D).
In this retrospective, observational study, data were collected from the Optum Market Clarity® database in the United States. People with T2D aged ≥18 years, previously treated with oral antidiabetic drugs ± basal insulin or glucagon-like peptide-1 receptor agonists, who initiated iGlarLixi between 1 January 2017 and 31 March 2020 and received ≥1 iGlarLixi prescription were included. The primary outcome was change in HbA1c 24 months after starting iGlarLixi. Secondary outcomes included change in HbA1c from baseline, achievement of HbA1c <7%, change in body weight and rate of hypoglycaemia (defined as inpatient or outpatient claims, or blood glucose <70 mg/dL) every 3 months over 24 months.
In total, 1685 people were included in this analysis (mean age, 58.4 years; 52.6% female). In the overall population, including imputed values, mean ± standard deviation (SD) baseline HbA1c (9.3 ± 1.8%) was reduced by 0.9% to 8.3 ± 1.8% at 24 months. A HbA1c target of <7% was achieved in 22.2% of people at 24 months. Mean ± SD body weight remained stable from baseline (102.1 ± 24.2 kg) to 24 months (101.9 ± 23.3 kg). The hypoglycaemia event rate was 16.1 per 100 person-years (P100PY) at baseline and decreased to 11.4 P100PY at 24 months.
iGlarLixi initiation was associated with improved glycaemic control, without body weight change or increased hypoglycaemia over 24 months.
评估甘精胰岛素100 U/mL与利司那肽(iGlarLixi)固定比例复方制剂在2型糖尿病(T2D)患者中应用24个月的有效性和安全性。
在这项回顾性观察研究中,数据取自美国Optum Market Clarity®数据库。纳入年龄≥18岁、既往接受口服降糖药±基础胰岛素或胰高血糖素样肽-1受体激动剂治疗、于2017年1月1日至2020年3月31日开始使用iGlarLixi且接受≥1次iGlarLixi处方的T2D患者。主要结局为开始使用iGlarLixi后24个月糖化血红蛋白(HbA1c)的变化。次要结局包括HbA1c相对于基线的变化、HbA1c <7%的达标情况、体重变化以及24个月内每3个月的低血糖发生率(定义为住院或门诊理赔,或血糖<70 mg/dL)。
本分析共纳入1685人(平均年龄58.4岁;52.6%为女性)。在总体人群中,包括推算值,基线时平均±标准差(SD)的HbA1c为(9.3±1.8%),24个月时降至8.3±1.8%,降低了0.9%。24个月时,22.2%的患者实现了HbA1c <7%的目标。平均±SD体重从基线时的(102.1±24.2 kg)至24个月时保持稳定(101.9±23.3 kg)。低血糖事件发生率在基线时为每100人年16.1次(P100PY),24个月时降至11.4 P100PY。
开始使用iGlarLixi与血糖控制改善相关,在24个月内未出现体重变化或低血糖增加。