A. Kok, H. Makan, G. Podgorski, S. Joshi, V. Chetty, L. Nojoko, H. Bacus, Naeem Moosa, D. Khutsoane
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Outcome measures: The primary endpoint was change in HbA1c from baseline to end of study. Results: Data were available from 179 patients. Prior to starting IDegAsp, the majority of the patients (76%) were already being treated with insulin therapy and the mean duration of follow-up was 210 days. The most commonly reported reasons for switching to IDegAsp were to improve glycaemic control (88.8%) and reduce the risk of hypoglycaemia (39.1%). In comparison with baseline values, mean HbA1c and fasting plasma glucose were significantly lower at end of study (8.4% vs. 9.6%; estimated mean difference −1.3% [95% confidence interval −1.6 to −1.1, p < 0.0001]; and 7.3 vs. 10.9 mmol/L; −3.5 mmol/L [−4.5 to −2.5, p < 0.0001], respectively). Improvement in glycaemic control after the switch to IDegAsp was achieved with lower daily insulin doses and less hypoglycaemia when compared with the time period prior to switch. Two patients discontinued IDegAsp due to adverse events. Conclusion: In this South African cohort, initiating or switching to IDegAsp was associated with improved glycaemic control, lower insulin dose requirements among patients already on insulin therapy, and significantly lower rates of non-severe (overall and nocturnal) and severe hypoglycaemia in comparison with previous therapy.","PeriodicalId":43919,"journal":{"name":"Journal of Endocrinology Metabolism and Diabetes of South Africa","volume":"63 1","pages":"92 - 99"},"PeriodicalIF":0.6000,"publicationDate":"2023-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Initiating or switching to IDegAsp in a real-world South African population with type 2 diabetes – a cohort analysis from the ARISE study\",\"authors\":\"A. Kok, H. Makan, G. Podgorski, S. Joshi, V. Chetty, L. Nojoko, H. Bacus, Naeem Moosa, D. Khutsoane\",\"doi\":\"10.1080/16089677.2023.2198348\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Background: The ARISE study was a 26-week, multicentre, prospective, open-label, non-interventional observational study to investigate clinical outcomes in people with T2D treated with IDegAsp in everyday clinical practice. Objectives: To report results from the South African cohort of the ARISE study and compare them with those from the overall population. Design: Non-interventional observational study. Setting: General and specialist private practices. Subjects: Adults ≥ 18 years of age with a diagnosis of T2D could be included in the study if they had been switched to, or had initiated, IDegAsp at the discretion of the treating physician. The primary endpoint was change in HbA1c from baseline to end of study. Outcome measures: The primary endpoint was change in HbA1c from baseline to end of study. Results: Data were available from 179 patients. Prior to starting IDegAsp, the majority of the patients (76%) were already being treated with insulin therapy and the mean duration of follow-up was 210 days. The most commonly reported reasons for switching to IDegAsp were to improve glycaemic control (88.8%) and reduce the risk of hypoglycaemia (39.1%). In comparison with baseline values, mean HbA1c and fasting plasma glucose were significantly lower at end of study (8.4% vs. 9.6%; estimated mean difference −1.3% [95% confidence interval −1.6 to −1.1, p < 0.0001]; and 7.3 vs. 10.9 mmol/L; −3.5 mmol/L [−4.5 to −2.5, p < 0.0001], respectively). Improvement in glycaemic control after the switch to IDegAsp was achieved with lower daily insulin doses and less hypoglycaemia when compared with the time period prior to switch. Two patients discontinued IDegAsp due to adverse events. 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引用次数: 0
摘要
背景:ARISE研究是一项为期26周、多中心、前瞻性、开放标签、非干预性观察性研究,旨在调查在日常临床实践中使用IDegAsp治疗T2D患者的临床结果。目的:报告ARISE研究的南非队列的结果,并将其与总体人群的结果进行比较。设计:非干预性观察研究。环境:普通和专业私人执业。受试者:年龄≥18岁且诊断为T2D的成年人,如果他们在治疗医生的决定下已经切换到或已经开始使用IDegAsp,则可以纳入研究。主要终点是HbA1c从基线到研究结束的变化。结果测量:主要终点是HbA1c从基线到研究结束的变化。结果:179例患者的数据。在开始使用IDegAsp之前,大多数患者(76%)已经接受胰岛素治疗,平均随访时间为210天。切换到IDegAsp最常见的报告原因是改善血糖控制(88.8%)和降低低血糖风险(39.1%)。与基线值相比,研究结束时平均HbA1c和空腹血糖显著降低(8.4% vs. 9.6%;估计平均差- 1.3%[95%置信区间- 1.6至- 1.1,p < 0.0001];7.3 vs. 10.9 mmol/L;4.5−3.5更易/ L(−−2.5,p < 0.0001),分别)。切换到IDegAsp后,与切换前相比,每日胰岛素剂量更低,低血糖发生率更低,血糖控制得到改善。2例患者因不良事件停用IDegAsp。结论:在这个南非队列中,启动或切换到IDegAsp与改善血糖控制有关,在已经接受胰岛素治疗的患者中,胰岛素剂量需求降低,与先前治疗相比,非严重(总体和夜间)和严重低血糖的发生率显著降低。
Initiating or switching to IDegAsp in a real-world South African population with type 2 diabetes – a cohort analysis from the ARISE study
Background: The ARISE study was a 26-week, multicentre, prospective, open-label, non-interventional observational study to investigate clinical outcomes in people with T2D treated with IDegAsp in everyday clinical practice. Objectives: To report results from the South African cohort of the ARISE study and compare them with those from the overall population. Design: Non-interventional observational study. Setting: General and specialist private practices. Subjects: Adults ≥ 18 years of age with a diagnosis of T2D could be included in the study if they had been switched to, or had initiated, IDegAsp at the discretion of the treating physician. The primary endpoint was change in HbA1c from baseline to end of study. Outcome measures: The primary endpoint was change in HbA1c from baseline to end of study. Results: Data were available from 179 patients. Prior to starting IDegAsp, the majority of the patients (76%) were already being treated with insulin therapy and the mean duration of follow-up was 210 days. The most commonly reported reasons for switching to IDegAsp were to improve glycaemic control (88.8%) and reduce the risk of hypoglycaemia (39.1%). In comparison with baseline values, mean HbA1c and fasting plasma glucose were significantly lower at end of study (8.4% vs. 9.6%; estimated mean difference −1.3% [95% confidence interval −1.6 to −1.1, p < 0.0001]; and 7.3 vs. 10.9 mmol/L; −3.5 mmol/L [−4.5 to −2.5, p < 0.0001], respectively). Improvement in glycaemic control after the switch to IDegAsp was achieved with lower daily insulin doses and less hypoglycaemia when compared with the time period prior to switch. Two patients discontinued IDegAsp due to adverse events. Conclusion: In this South African cohort, initiating or switching to IDegAsp was associated with improved glycaemic control, lower insulin dose requirements among patients already on insulin therapy, and significantly lower rates of non-severe (overall and nocturnal) and severe hypoglycaemia in comparison with previous therapy.