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

IF 3.8 3区 医学 Q2 Medicine
Diabetes Therapy Pub Date : 2024-07-01 Epub Date: 2024-05-08 DOI:10.1007/s13300-024-01593-8
Alex Ramírez-Rincón, Diana Henao-Carrillo, Miguel Omeara, Julio Oliveros, José Assaf, Jaime E Ordóñez, Preethy Prasad, María Alejandra Alzate
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引用次数: 0

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.

Abstract Image

SPIRIT:评估哥伦比亚 2 型糖尿病患者在实际环境中使用 IDegLira 的相关临床参数。
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])的固定比例组合。本研究旨在调查哥伦比亚真实世界中的 2 型糖尿病(T2DM)患者在接受 IDegLira 治疗后的临床疗效:SPIRIT是一项非干预、单臂、回顾性病历审查研究,旨在评估T2DM患者的临床疗效。参与研究的患者从基础胰岛素治疗方案(使用或不使用口服抗糖尿病药[OADs])转为IDegLira治疗方案,并在数据收集开始日期前至少26±6周开始使用IDegLira。数据来自哥伦比亚 10 个临床中心 175 名患者的医疗记录:结果:与基线值相比,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 结论:IDegLira 可显著降低糖化血红蛋白(HbA1c):在实际应用中,对之前接受基础胰岛素(± OAD)治疗的 T2DM 患者启用 IDegLira 与血糖控制的改善、体重的减轻和低血糖风险的降低有关:试验注册:ClinicalTrials.gov identifier:试验注册:ClinicalTrials.gov 标识符:NCT05324462。
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来源期刊
Diabetes Therapy
Diabetes Therapy Medicine-Endocrinology, Diabetes and Metabolism
CiteScore
6.90
自引率
7.90%
发文量
130
审稿时长
6 weeks
期刊介绍: Diabetes Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all areas of diabetes. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Diabetes Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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