Diabetology International

, Volume 7, Issue 4, pp 404–412 | Cite as

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

  • Y. Ono
  • T. Nishida
  • J. Hyllested-Winge
  • H. Seino
  • T. Sasaki
Original Article
  • 122 Downloads

Abstract

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.

Keywords

Type 1 diabetes mellitus Insulin Bolus treatment Japanese 

Notes

Acknowledgments

Medical writing assistance was provided by apothecom scopemedical, UK, and funded by Novo Nordisk.

Compliance with ethical standards

Conflict of interest

Y. Ono has received grants from the Advanced Clinical Research Organization of Japan. T. Nishida is an employee of Novo Nordisk. J. Hyllested-Winge is an employee and shareholder in Novo Nordisk. H. Seino has received honoraria from Astellas, Eli Lilly, Novartis, Sanofi, Shionogi, Boehringer Ingelheim and Mitsubishi Tanabe. He has also received research grants from GSK, Sanofi, Novo Nordisk and Mitsubishi Tanabe Pharma. T. Sasaki has no conflicts to declare.

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Copyright information

© The Japan Diabetes Society 2016

Authors and Affiliations

  • Y. Ono
    • 1
  • T. Nishida
    • 2
  • J. Hyllested-Winge
    • 2
  • H. Seino
    • 3
  • T. Sasaki
    • 4
  1. 1.Yuri Ono Clinic, Diabetes, Internal MedicineSapporoJapan
  2. 2.Novo Nordisk Pharma LtdTokyoJapan
  3. 3.Seino Internal Medicine ClinicFukushimaJapan
  4. 4.Sasaki Hospital Internal MedicineHokkaidoJapan

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