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
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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.
KeywordsInsulin degludec Insulin-naive Japan Type 2 diabetes Phase 3 Once-daily
This study was funded by Novo Nordisk. Editorial assistance was provided by apothecom scopemedical and funded by Novo Nordisk.
Compliance with ethical standards
Conflict of interest
T. Osonoi received honoraria for provision of consultation or manuscripts from Novo Nordisk, Astellas, Takeda Pharmaceutical, Sanwa Kagaku Kenkyusho, Mitsubishi Tanabe Pharma and Kowa Pharmaceuticals. He also received clinical research grants from Novo Nordisk, Sanwa Kagaku Kenkyusho, Mitsubishi Tanabe Pharma, Fujiflim Pharma, Eli Lilly Japan, Abbvie, Kowa Pharmaceuticals, Taisho Pharmaceuticals, GSK and Sumitomo Dainippon Pharma. Y. Onishi received honoraria from AstraZeneca. T. Nishida is an employee of Novo Nordisk. J. Hyllested-Winge is an employee of and shareholder in Novo Nordisk. Y. Iwamoto has received honoraria for participation on advisory panels from Novo Nordisk.
Human rights statement and informed consent
All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Declaration of Helsinki of 1964 and later revision. Informed consent or substitute for it was obtained from all patients for study inclusion.
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