Initiating or switching to IDegAsp in a real-world South African population with type 2 diabetes – a cohort analysis from the ARISE study

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. 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.