iGlarLixi治疗未接受胰岛素治疗的2型糖尿病患者16周后的治疗满意度和时间范围

IF 5.7 2区 医学 Q1 ENDOCRINOLOGY & METABOLISM
Viral N. Shah MD, Terry Dex PharmD, Luigi Meneghini MD, Amélie Rodrigues MSc, William H. Polonsky PhD
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引用次数: 0

摘要

目的:在Soli-CGM中,iGlarLixi(甘精胰岛素100 U/mL和利昔那肽33 μg/mL)治疗未接受胰岛素治疗的成人亚理想控制2型糖尿病(T2D;≥2种口服抗高血糖药物(OADs)±胰高血糖素样肽-1受体激动剂(GLP-1 RA)治疗的血红蛋白A1c增加9%-13%,范围(TIR;主要终点)从基线时的26.4%降至第16周时的52.7%。本探索性分析考察了iGlarLixi治疗对患者报告的治疗满意度的影响。材料和方法:Soli-CGM是一项单臂、16周、多中心、介入性、开放标签的4期研究,采用盲法连续血糖监测(CGM;FreeStyle Libre Pro)评估血糖指标(N = 124)。在开始iGlarLixi治疗前2周和iGlarLixi治疗后(14-16周)收集CGM数据。使用糖尿病药物治疗满意度工具(DM-SAT)评估治疗满意度,该工具包括四个领域:幸福感、医疗控制、生活方式和便利性)、基线和治疗结束时。还评估了TIR与总体满意度(所有项目的总和)的关联。结果:总体而言,118名(95.9%)和107名(87.0%)参与者分别在基线和第16周完成了DM-SAT。平均总分增加0.18,从0.59(基线)到0.78(第16周)。所有领域的得分都有提高的趋势。TIR的改善与整体治疗满意度的改善呈正相关,但趋势较弱(平均r = 0.14)。结论:在控制在≥2 OADs±GLP-1 RA的T2D亚优患者中,iGlarLixi治疗16周后治疗满意度有改善趋势。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Treatment satisfaction and time in range after 16 weeks of treatment with iGlarLixi in insulin-naive adults with suboptimally controlled type 2 diabetes

Treatment satisfaction and time in range after 16 weeks of treatment with iGlarLixi in insulin-naive adults with suboptimally controlled type 2 diabetes

Treatment satisfaction and time in range after 16 weeks of treatment with iGlarLixi in insulin-naive adults with suboptimally controlled type 2 diabetes

Treatment satisfaction and time in range after 16 weeks of treatment with iGlarLixi in insulin-naive adults with suboptimally controlled type 2 diabetes

Treatment satisfaction and time in range after 16 weeks of treatment with iGlarLixi in insulin-naive adults with suboptimally controlled type 2 diabetes

Aims

In Soli-CGM, treatment with iGlarLixi (insulin glargine 100 U/mL and lixisenatide 33 μg/mL) in insulin-naive adults with suboptimally controlled type 2 diabetes (T2D; haemoglobin A1c 9%–13% on ≥2 oral antihyperglycaemic agents (OADs) ± glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy) increased time in range (TIR; primary endpoint) from 26.4% at baseline to 52.7% at Week 16. This exploratory analysis examined the impact of treatment with iGlarLixi on patient-reported treatment satisfaction.

Materials and Methods

Soli-CGM was a single-arm, 16-week, multicentre, interventional, open-label, phase 4 study using blinded continuous glucose monitoring (CGM; FreeStyle Libre Pro) to assess glycaemic metrics (N = 124). CGM data were collected for a 2-week period before initiation of iGlarLixi, and after treatment with iGlarLixi (Weeks 14–16). Treatment satisfaction was assessed using the Diabetes Medication Treatment Satisfaction Tool (DM-SAT, which comprises four domains: well-being, medical control, lifestyle and convenience), at baseline and end-of-treatment. Association of TIR and overall satisfaction (sum of all items) was also assessed.

Results

Overall, 118 (95.9%) and 107 (87.0%) participants completed the DM-SAT at baseline and Week 16, respectively. Mean overall score increased by 0.18, from 0.59 (baseline) to 0.78 (Week 16). A trend in improvement in score was observed in all domains. Improvement in TIR had a positive, but weak, trend of association with improvement in overall treatment satisfaction (mean r = 0.14).

Conclusions

In people with T2D suboptimally controlled on ≥2 OADs ± GLP-1 RA, 16 weeks' treatment with iGlarLixi resulted in a trend of improvement in treatment satisfaction.

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来源期刊
Diabetes, Obesity & Metabolism
Diabetes, Obesity & Metabolism 医学-内分泌学与代谢
CiteScore
10.90
自引率
6.90%
发文量
319
审稿时长
3-8 weeks
期刊介绍: Diabetes, Obesity and Metabolism is primarily a journal of clinical and experimental pharmacology and therapeutics covering the interrelated areas of diabetes, obesity and metabolism. The journal prioritises high-quality original research that reports on the effects of new or existing therapies, including dietary, exercise and lifestyle (non-pharmacological) interventions, in any aspect of metabolic and endocrine disease, either in humans or animal and cellular systems. ‘Metabolism’ may relate to lipids, bone and drug metabolism, or broader aspects of endocrine dysfunction. Preclinical pharmacology, pharmacokinetic studies, meta-analyses and those addressing drug safety and tolerability are also highly suitable for publication in this journal. Original research may be published as a main paper or as a research letter.
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