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Diabetology International

, Volume 7, Issue 2, pp 141–147 | Cite as

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

  • T. OsonoiEmail author
  • Y. Onishi
  • T. Nishida
  • J. Hyllested-Winge
  • Y. Iwamoto
Original Article

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 (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.

Keywords

Insulin degludec Insulin-naive Japan Type 2 diabetes Phase 3 Once-daily 

Notes

Acknowledgments

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.

References

  1. 1.
    Inzucchi SE, Bergenstal RM, Buse JB, 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. 2012;55:1577–96.CrossRefPubMedGoogle Scholar
  2. 2.
    Chen KW, Boyko EJ, Bergstrom RW, Leonetti DL, Newell-Morris L, Wahl PW, 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. 1995;18:747–53.CrossRefPubMedGoogle Scholar
  3. 3.
    Ma RC, Chan JC. Type 2 diabetes in East Asians: similarities and differences with populations in Europe and the United States. Ann N Y Acad Sci. 2013;1281:64–91.CrossRefPubMedPubMedCentralGoogle Scholar
  4. 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. 2004;53:831–5.CrossRefPubMedGoogle Scholar
  5. 5.
    Yoon KH, Lee JH, Kim JW, Cho JH, Choi YH, Ko SH, et al. Epidemic obesity and type 2 diabetes in Asia. Lancet. 2006;368:1681–8.CrossRefPubMedGoogle Scholar
  6. 6.
    Neville SE, Boye KS, Montgomery WS, Iwamoto K, Okamura M, Hayes RP. Diabetes in Japan: a review of disease burden and approaches to treatment. Diabetes Metab Res Rev. 2009;25:705–16.CrossRefPubMedGoogle Scholar
  7. 7.
    Heise T, Nosek L, Bøttcher SG, Hastrup H, Haahr H. Ultra-long-acting insulin degludec has a flat and stable glucose-lowering effect in type 2 diabetes. Diabetes Obes Metab. 2012;14:944–50.CrossRefPubMedGoogle Scholar
  8. 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. 2012;14:859–64.CrossRefPubMedGoogle Scholar
  9. 9.
    Rodbard HW, Cariou B, Zinman B, Handelsman Y, Philis-Tsimikas A, Skjøth TV, 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. 2013;30:1298–304.CrossRefPubMedPubMedCentralGoogle Scholar
  10. 10.
    Zinman B, Philis-Tsimikas A, Cariou B, Handelsman Y, Rodbard HW, 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. 2012;35:2464–71.CrossRefPubMedPubMedCentralGoogle Scholar
  11. 11.
    Onishi Y, Iwamoto Y, Yoo SJ, Clauson P, Tamer SC, Park S. Insulin degludec compared with insulin glargine in insulin-naive patients with type 2 diabetes: a 26-week, randomized, controlled, Pan-Asian, treat-to-target trial. J Diabetes Investig. 2013;4:605–12.CrossRefPubMedPubMedCentralGoogle Scholar
  12. 12.
    FDA. Guidance for Industry. Diabetes mellitus: developing drugs and therapeutic biologics for treatment and prevention. 2008. http://www.fda.gov/downloads/Drugs/Guidances/ucm071624.pdf. Accessed Nov 2014.
  13. 13.
    Workgroup on Hypoglycemia, American Diabetes Association. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care. 2005;28:1245–9.CrossRefGoogle Scholar

Copyright information

© The Japan Diabetes Society 2015

Authors and Affiliations

  • T. Osonoi
    • 1
    Email author
  • Y. Onishi
    • 2
  • T. Nishida
    • 3
  • J. Hyllested-Winge
    • 3
  • Y. Iwamoto
    • 2
  1. 1.Internal MedicineNaka Memorial ClinicNaka-shiJapan
  2. 2.The Institute for Adult DiabetesAsahi Life FoundationTokyoJapan
  3. 3.Novo Nordisk Pharma LtdTokyoJapan

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