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.

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 (HbA1c) 8.5 %]. After 26 weeks, mean HbA1c 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.

A comparison of IDeg + IAsp versus IDet + IAsp in subjects with type 1 diabetes: subgroup analysis of Japanese subjects.

OBJECTIVE: Efficacy and safety were compared between insulin degludec (IDeg) once daily (OD) in combination with mealtime insulin aspart (IAsp) and insulin detemir (IDet) OD or twice daily (BID) in combination with mealtime IAsp in Japanese subjects with type 1 diabetes mellitus (T1DM). MATERIALS AND METHODS: This was a post hoc analysis of a multinational, controlled, open-label, parallel-group, treat-to-target trial that randomised adults [aged ≥18 years (≥20 years for Japan)] with T1DM for ≥12 months to basal IDeg OD (n = 124) or IDet (n = 62), both with mealtime bolus IAsp. The IDet dosing was adjusted to BID if required at ≥8 weeks. RESULTS: The estimated mean change in HbA1c from baseline to week 26 (the primary outcome measure) was -1.03 % in the IDeg + IAsp group and -0.94 % in the IDet + IAsp group (mean estimated treatment difference [ETD] -0.09; 95 % confidence interval [CI] -0.29, 0.10). Significantly greater reductions in fasting plasma glucose were observed in the IDeg + IAsp group (mean ETD -39.36 mg/dL; 95 % CI -56.04, -22.68). Both groups had similar rates of confirmed hypoglycaemia (59.9 and 59.2 per patient-year of exposure [PYE] with IDeg + IAsp and IDet + IAsp, respectively). Rates of nocturnal confirmed hypoglycaemia were significantly lower with IDeg + IAsp than with IDet + IAsp (5.2 vs 9.5 episodes per PYE; estimated ratio 0.48; 95 % CI 0.31, 0.75). Adverse event profiles were similar. CONCLUSION: The findings were consistent with those of the global trial population. IDeg + IAsp may represent an improvement on current standard treatments for Japanese patients with T1DM.