Ramírez-Rincón Alex, Henao-Carrillo Diana, Omeara Miguel, Oliveros Julio, Assaf José, Ordóñez Jaime E, Prasad Preethy, Alzate María Alejandra
Universidad Pontificia Bolivariana, Medellín, Colombia.
Pontificia Universidad Javeriana, Bogotá D.C., Colombia.
Diabetes Ther. 2024 Jul;15(7):1535-1545. doi: 10.1007/s13300-024-01593-8. Epub 2024 May 8.
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.
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.
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.
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.
ClinicalTrials.gov identifier: NCT05324462.
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。
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。
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。
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。
ClinicalTrials.gov标识符:NCT05324462。