Switching to Degludec is Associated with Reduced Hypoglycaemia, Irrespective of Definition Used or Patient Characteristics: Secondary Analysis of the ReFLeCT Prospective, Observational Study

• Published in: Diabetes therapy 2020-09, Vol.11 (9), p.2159-2167
• Main Authors: de Valk, Harold W., Feher, Michael, Hansen, Troels Krarup, Jendle, Johan, Koefoed, Mette Marie, Rizi, Ehsan Parvaresh, Zimmermann, Esther, Fadini, Gian Paolo
• Format: Article
• Language: English
• Subjects: Basal insulin; Brief Report; Cardiology; Diabetes; Drug therapy; Endocrinology; Hypoglycaemia; Hypoglycemia; Insulin; Insulin degludec; Internal Medicine; Medicine; Medicine & Public Health; Observational studies; Patients; Type 1 diabetes; Type 2 diabetes
• ISSN: 1869-6953; 1869-6961; 1869-6961
• DOI: 10.1007/s13300-020-00875-1

Introduction Hypoglycaemia is a common side effect of insulin therapy; low or high glycated haemoglobin (HbA 1c ) levels, history of hypoglycaemia or long diabetes duration are known modifiers of hypoglycaemia risk. In randomised clinical trials, lower rates of hypoglycaemia have been observed with the new-generation insulin analogue, long-acting insulin degludec, compared with other basal insulins. Methods The ReFLeCT study was a prospective observational study over 12 months. Patient-reported diary data on hypoglycaemia were collected from patients with type 1 diabetes (T1D) or type 2 diabetes (T2D) who were switching from other basal insulins to insulin degludec (degludec) at their physician’s discretion in routine clinical care. Two secondary analyses were undertaken to investigate the change in number of hypoglycaemic events: a post hoc analysis using the updated American Diabetes Association (ADA) level 1, 2 and 3 hypoglycaemia definitions, and a pre-specified analysis using patient characteristics (baseline HbA 1c , diabetes duration, and physician’s rationale for initiating degludec). Results Switching to degludec was associated with significantly fewer hypoglycaemic events for all definitions in T1D, and level 1 and 2 in T2D (too few level 3 events for statistical comparison). Moreover, patient characteristics did not influence the observed reduction in hypoglycaemia in T1D and T2D. Conclusion These results demonstrate that switching to degludec from other basal insulins was associated with reduced rates of hypoglycaemia, irrespective of the definition used or baseline patient characteristics. Trial Registration NCT02392117 Plain Language Summary Low blood sugar levels (hypoglycaemia) are a common, and sometimes serious, side effect of treatment with insulin in people with diabetes. In the ReFleCT study, adults with type 1 (T1D) and type 2 diabetes (T2D) were asked to complete a diary for 12 months when their doctor changed their previous long-acting insulin treatment to insulin degludec (degludec). The key outcome of the study was whether the frequency of hypoglycaemia changed when a patient’s insulin treatment was switched. Here, we used the diary information from the ReFLeCT study to investigate whether the change in the rate of hypoglycaemia was related to the way hypoglycaemia was defined, or to patients’ characteristics at the time their insulin was switched. These characteristics included the length of time that patients had had diabetes, t