Abstract
Introduction Insulin degludec (degludec) has proven benefits in type 2 diabetes (T2D), in terms of improved glycaemic control, low risk of hypoglycaemia, and flexibility in dosing time. This prospective non-interventional UPDATES study aimed to investigate whether results obtained from randomised clinical trials and other real-world studies with degludec are generalisable to patients with T2D in routine clinical practice in Saudi Arabia. Methods Eligible adults (n = 561) with T2D received degludec for 26-34 weeks, at physicians' discretion and in accordance with local routine clinical practice. The primary endpoint was mean change in HbA(1c) from baseline to end of study (EOS). Secondary endpoints included mean change from baseline to EOS in fasting plasma glucose (FPG), daily insulin dose and rate of hypoglycaemia. Results At baseline, mean age, HbA(1c) and FPG were 55.7 years, 9.4% and 185.6 mg/dL, respectively. Mean (standard error [SE]) changes from baseline to EOS (crude analysis) were statistically significant for HbA(1c) (- 1.1 [0.08] %-points, 95% CI - 1.29, - 0.98; P < 0.0001), FPG (- 39.1 [3.42] mg/dL, 95% CI - 45.9, - 32.4; P < 0.0001) and total daily insulin dose (+ 4.7 [1.6] units, 95% CI 1.63, 7.86; P = 0.003, insulin-experienced population). In exploratory analysis of patients switching from insulin glargine U100 or U300 to degludec, similar reductions were seen in HbA(1c) and FPG. The rate of hypoglycaemia was significantly reduced with degludec versus previous treatment, with no apparent or unexpected safety and tolerability issues. The number of insulin-experienced patients utilising resources associated with severe hypoglycaemia was also reduced. Most patients (95.5%) were willing to continue treatment at EOS, and expressed a preference for degludec over their previous regimen (93.0%). Conclusion Patients with T2D treated with degludec in routine clinical practice in Saudi Arabia experienced clinically significant improvements in glycaemic control and a lower rate of hypoglycaemia compared with baseline, with no new safety concerns reported.