Yale Jean-François, Roborel de Climens Aude, Aggarwal Naresh, Dex Terry, Gerstein Hertzel C, Harris Stewart, Hramiak Irene, Stewart John, Leiter Lawrence A
Department of Medicine, McGill University Health Centre, 1001 Decarie, Montreal, QC, H4A3J1, Canada.
Sanofi, Lyon, France.
Diabetes Ther. 2023 Feb;14(2):377-386. doi: 10.1007/s13300-022-01353-6. Epub 2022 Dec 27.
For people with type 2 diabetes mellitus who do not achieve glycated hemoglobin A1C targets after treatment with basal insulin therapies, additional therapy with a glucagon-like peptide-1 receptor agonist (GLP-1 RA) may be required. One option is to use a once-daily fixed-ratio combination (FRC) of basal insulin and a GLP-1 RA such as iGlarLixi (which is composed of insulin glargine 100 U/ml and lixisenatide). However, the ease of transitioning from basal insulin to an FRC has not been studied.
This sub-study of the LixiLan ONE CAN trial (NCT03767543) was conducted to assess the ease of transitioning from insulin glargine 100 U/ml to the FRC, iGlarLixi, using the iGlarLixi SoloStar pen. Patients completed a validated, ten-item questionnaire, and healthcare professionals (HCPs) completed a five-item questionnaire. Both questionnaires used either five-point Likert scales or yes/no answers as appropriate, and both were completed after 4 weeks of using the iGlarLixi SoloStar pen.
Overall, 95.1% of patients reported that the iGlarLixi Solostar pen was "easy" or "very easy" to use. Similarly, 100% of HCPs reported that it was "easy" or "very easy" to train people to use the pen. Nearly all participants (97.5% of patients and 94% of HCPs) responded that they would recommend the iGlarLixi Solostar pen to others.
These results suggest that during the transition from insulin glargine 100 U/ml to iGlarLixi, there were no difficulties associated with using the iGlarLixi SoloStar pen injector regarding instruction for use by HCPs or actual use by the majority of patients. The results indicate a broad consensus between patients and HCPs on the relative simplicity of transitioning from self-administration of insulin glargine 100 U/ml to iGlarLixi.
ClinicalTrials.gov identifier, NCT03767543; Date of registration: December 6, 2018; Retrospectively registered.
对于接受基础胰岛素治疗后糖化血红蛋白A1C未达标的2型糖尿病患者，可能需要加用胰高血糖素样肽-1受体激动剂（GLP-1 RA）进行额外治疗。一种选择是使用基础胰岛素与GLP-1 RA的每日一次固定比例复方制剂（FRC），如iGlarLixi（由100 U/ml的甘精胰岛素和利司那肽组成）。然而，从基础胰岛素转换为FRC的难易程度尚未得到研究。
本研究是LixiLan ONE CAN试验（NCT03767543）的子研究，旨在评估使用iGlarLixi SoloStar笔从100 U/ml甘精胰岛素转换为FRC iGlarLixi的难易程度。患者完成一份经过验证的包含10个条目的问卷，医疗保健专业人员（HCP）完成一份包含5个条目的问卷。两份问卷均酌情使用5点李克特量表或“是/否”答案，且均在使用iGlarLixi SoloStar笔4周后完成。
总体而言，95.1%的患者报告iGlarLixi SoloStar笔“易于使用”或“非常易于使用”。同样，100%的HCP报告培训人们使用该笔“容易”或“非常容易”。几乎所有参与者（97.5%的患者和94%的HCP）表示会向他人推荐iGlarLixi SoloStar笔。
这些结果表明，在从100 U/ml甘精胰岛素转换为iGlarLixi的过程中，就HCP的使用指导或大多数患者的实际使用而言，使用iGlarLixi SoloStar笔注射不存在困难。结果表明，患者和HCP在从自行注射100 U/ml甘精胰岛素转换为iGlarLixi的相对简易性方面达成了广泛共识。
ClinicalTrials.gov标识符，NCT03767543；注册日期：2018年12月6日；回顾性注册。
