Insulin degludec versus insulin glargine, both once daily as add-on to existing orally administered antidiabetic drugs in insulin-naive Japanese patients with uncontrolled type 2 diabetes: subgroup analysis of a pan-Asian, treat-to-target phase 3 trial

Abstract

Insulin degludec (IDeg) is a novel basal insulin analogue with an ultralong duration of action that provides flat and stable reductions in blood glucose. The BEGIN ONCE ASIA trial was a phase 3 pan-Asian study examining the efficacy and safety of IDeg once daily (OD) versus insulin glargine (IGlar) OD in insulin-naive patients with type 2 diabetes (T2D). In this multinational, 26-week, open-label, treat-to-target trial, participants were randomised (2:1) to IDeg OD or IGlar OD, administered with one or more antidiabetic drugs (OAD) per os. Here we report the results from a post hoc analysis of Japanese patients enrolled in the trial [n = 133; 63.2 % male; mean age 61.0 years; mean body mass index 24.1 kg/m²; mean glycosylated haemoglobin (HbA_1c) 8.5 %]. After 26 weeks, mean HbA_1c levels were similar between the two groups [estimated mean treatment difference 0.11 %; 95 % confidence interval (CI) -0.09, 0.31]. Confirmed hypoglycaemia was reported in 53.4 and 61.4 % of patients in the IDeg OD and IGlar OD groups [rate ratio (IDeg/IGlar) 0.87; 95 % CI 0.51, 1.48]. Confirmed nocturnal hypoglycaemia was reported in 17.0 and 22.7 % of patients in the IDeg OD and IGlar OD groups, respectively [rate ratio (IDeg/IGlar) 0.50; 95 % CI 0.19, 1.32]. Adverse event rates were similar between treatment groups. Initiating insulin treatment with IDeg OD in Japanese patients with T2D, inadequately maintained on OADs and requiring treatment intensification, provided effective glycaemic control with low rates of confirmed and nocturnal confirmed hypoglycaemia.

Keywords: Insulin degludec; Insulin-naive; Japan; Once-daily; Phase 3; Type 2 diabetes.

Fig. 1

Trial flow diagram (Japanese subpopulation). IDeg insulin degludec, IGlar insulin glargine, OD once daily

Fig. 2

Mean HbA_1c levels over 26 weeks of treatment with once-daily insulin degludec or insulin glargine in the Japanese subpopulation. FAS, LOCF imputed data. Error bars indicate ± standard error of the mean. FAS full analysis set, HbA _1c glycosylated haemoglobin, IDeg insulin degludec, IGlar insulin glargine, LOCF last observation carried forward, OD once daily

Fig. 3

Mean FPG levels over 26 weeks of treatment with once-daily insulin degludec or insulin glargine in the Japanese subpopulation. FAS, LOCF imputed data. Error bars indicate ± standard error of mean. FAS full analysis set, FPG fasting plasma glucose, IDeg insulin degludec, IGlar insulin glargine, LOCF last observation carried forward, OD once daily

Fig. 4

Nine-point self-measured plasma glucose profiles at baseline and after 26 weeks of treatment with once daily insulin degludec or insulin glargine in the Japanese subpopulation. Asterisk denotes statistically significant difference between treatments at week 26. FAS, LOCF imputed data. FAS full analysis set, IDeg insulin degludec, IGlar insulin glargine, LOCF last observation carried forward, OD once daily

Fig. 5

Confirmed and nocturnal confirmed hypoglycaemic episodes over 26 weeks of treatment with once-daily insulin degludec or insulin glargine in the Japanese subpopulation. Nocturnal: 00:01–05:59 h (inclusive). IDeg insulin degludec, IGlar insuline glargine, OD once daily