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

被引：7
作者：
Osonoi T. [1 ]
Onishi Y. [2 ]
Nishida T. [3 ]
Hyllested-Winge J. [3 ]
Iwamoto Y. [2 ]
机构：
[1] Internal Medicine, Naka Memorial Clinic, 745-5 Nakadai, Naka-shi, 311-0113, Ibaraki
[2] The Institute for Adult Diabetes, Asahi Life Foundation, 2-2-6, Nihonbashi, Bakurocho, Chuo-ku, Tokyo
[3] Novo Nordisk Pharma Ltd, Meiji Yasuda Seimei Building, 2-1-1 Marunouchi, Chiyoda-Ku, Tokyo
来源：
Diabetology International | 2016年 / 7卷 / 2期
关键词：
Insulin degludec; Insulin-naive; Japan; Once-daily; Phase; 3; Type; 2; diabetes;
D O I：
10.1007/s13340-015-0221-3
中图分类号：
学科分类号：
摘要：
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. © 2015, The Japan Diabetes Society.
引用
收藏
页码：141 / 147
页数：6
相关论文
共 13 条
[1]  
Inzucchi S.E., Bergenstal R.M., Buse J.B., Diamant M., Ferrannini E., Nauck M., Et al., Management of hyperglycaemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD), Diabetologia, 55, pp. 1577-1596, (2012)
[2]  
Chen K.W., Boyko E.J., Bergstrom R.W., Leonetti D.L., Newell-Morris L., Wahl P.W., Et al., Earlier appearance of impaired insulin secretion than of visceral adiposity in the pathogenesis of NIDDM. 5-Year follow-up of initially nondiabetic Japanese-American men, Diabetes Care, 18, pp. 747-753, (1995)
[3]  
Ma R.C., Chan J.C., Type 2 diabetes in East Asians: similarities and differences with populations in Europe and the United States, Ann N Y Acad Sci, 1281, pp. 64-91, (2013)
[4]  
Fukushima M., Usami M., Ikeda M., Nakai Y., Taniguchi A., Matsuura T., Et al., Insulin secretion and insulin sensitivity at different stages of glucose tolerance: a cross-sectional study of Japanese type 2 diabetes, Metabolism., 53, pp. 831-835, (2004)
[5]  
Yoon K.H., Lee J.H., Kim J.W., Cho J.H., Choi Y.H., Ko S.H., Et al., Epidemic obesity and type 2 diabetes in Asia, Lancet, 368, pp. 1681-1688, (2006)
[6]  
Neville S.E., Boye K.S., Montgomery W.S., Iwamoto K., Okamura M., Hayes R.P., Diabetes in Japan: a review of disease burden and approaches to treatment, Diabetes Metab Res Rev., 25, pp. 705-716, (2009)
[7]  
Heise T., Nosek L., Bottcher S.G., Hastrup H., Haahr H., Ultra-long-acting insulin degludec has a flat and stable glucose-lowering effect in type 2 diabetes, Diabetes Obes Metab, 14, pp. 944-950, (2012)
[8]  
Heise T., Hermanski L., Nosek L., Feldman A., Rasmussen S., Haahr H., Insulin degludec: four times lower pharmacodynamic variability than insulin glargine under steady-state conditions in type 1 diabetes, Diabetes Obes Metab, 14, pp. 859-864, (2012)
[9]  
Rodbard H.W., Cariou B., Zinman B., Handelsman Y., Philis-Tsimikas A., Skjoth T.V., Et al., Comparison of insulin degludec with insulin glargine in insulin-naive subjects with Type 2 diabetes: a 2-year randomized, treat-to-target trial, Diabet Med, 30, pp. 1298-1304, (2013)
[10]  
Zinman B., Philis-Tsimikas A., Cariou B., Handelsman Y., Rodbard H.W., Johansen T., Et al., Insulin degludec versus insulin glargine in insulin-naive patients with type 2 diabetes: a 1-year, randomized, treat-to-target trial (BEGIN Once Long), Diabetes Care, 35, pp. 2464-2471, (2012)
12