Suppr超能文献

SPIRIT:在哥伦比亚的实际临床环境中评估与2型糖尿病患者使用德谷胰岛素利拉鲁肽相关的临床参数。

SPIRIT: Assessing Clinical Parameters Associated with Using IDegLira in Patients with Type 2 Diabetes in a Real-World Setting in Colombia.

作者信息

Ramírez-Rincón Alex, Henao-Carrillo Diana, Omeara Miguel, Oliveros Julio, Assaf José, Ordóñez Jaime E, Prasad Preethy, Alzate María Alejandra

机构信息

Universidad Pontificia Bolivariana, Medellín, Colombia.

Pontificia Universidad Javeriana, Bogotá D.C., Colombia.

出版信息

Diabetes Ther. 2024 Jul;15(7):1535-1545. doi: 10.1007/s13300-024-01593-8. Epub 2024 May 8.

Abstract

INTRODUCTION

Insulin degludec/liraglutide (IDegLira) is a fixed-ratio combination of insulin degludec (a basal insulin) and liraglutide (a glucagon-like peptide-1 receptor agonist [GLP-1RA]). This study aimed to investigate clinical outcomes in people with type 2 diabetes mellitus (T2DM) after initiating IDegLira treatment in a real-world setting in Colombia.

METHODS

SPIRIT is a non-interventional, single-arm, retrospective chart review study to assess clinical outcomes in people with T2DM. Participating patients were switched from a treatment regimen of basal insulin (with or without oral antidiabetics [OADs]) and started on treatment with IDegLira a minimum of 26 ± 6 weeks before the data collection start date. Data were collected from the medical records of 175 patients in ten clinical centers across Colombia.

RESULTS

Compared with baseline, there was a significant reduction in glycated hemoglobin (HbA1c) (1.3%; 95% confidence interval [CI] - 1.6 to - 1.0; p < 0.0001) after 26 ± 6 weeks of follow-up. The mean HbA1c at baseline and at the end of the study was 9.1% and 7.8%, respectively. In addition, IDegLira significantly reduced absolute body weight by 1 kg (95% CI - 1.5 to - 0.5; p < 0.0001), from a mean of 76.1 kg at baseline to 75.1 kg after follow-up. The mean IDegLira dose at the end of the study was 21.3 U, and no severe hypoglycemic events were observed during the follow-up period.

CONCLUSION

In real-world practice, initiating IDegLira in patients with T2DM previously treated with basal insulin (± OAD) was associated with improved glycemic control, reduced body weight and reduced risk of hypoglycemia.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT05324462.

摘要

简介

德谷胰岛素/利拉鲁肽(IDegLira)是德谷胰岛素(一种基础胰岛素)和利拉鲁肽(一种胰高血糖素样肽-1受体激动剂[GLP-1RA])的固定比例复方制剂。本研究旨在调查哥伦比亚真实世界环境中2型糖尿病(T2DM)患者开始使用IDegLira治疗后的临床结局。

方法

SPIRIT是一项非干预性、单臂、回顾性病历审查研究,以评估T2DM患者的临床结局。参与研究的患者从基础胰岛素治疗方案(联合或不联合口服降糖药[OADs])转换治疗,在数据收集开始日期前至少26±6周开始使用IDegLira治疗。数据从哥伦比亚十个临床中心的175例患者的医疗记录中收集。

结果

与基线相比,随访26±6周后糖化血红蛋白(HbA1c)显著降低(1.3%;95%置信区间[CI]-1.6至-1.0;p<0.0001)。基线时和研究结束时的平均HbA1c分别为9.1%和7.8%。此外,IDegLira使绝对体重显著降低1kg(95%CI-1.5至-0.5;p<0.0001),从基线时的平均76.1kg降至随访后的75.1kg。研究结束时IDegLira的平均剂量为21.3U,随访期间未观察到严重低血糖事件。

结论

在现实世界实践中,先前接受基础胰岛素(±OAD)治疗的T2DM患者开始使用IDegLira与血糖控制改善、体重减轻和低血糖风险降低相关。

试验注册

ClinicalTrials.gov标识符:NCT05324462。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b0d6/11211291/e74bf744e25a/13300_2024_1593_Fig1_HTML.jpg

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验