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Insulin degludec/insulin aspart vs biphasic insulin aspart 30 twice daily in Japanese patients with type 2 diabetes: A randomized controlled trial.
J Diabetes Investig. 2017 Mar; 8(2):210-217.JD

Abstract

AIMS/INTRODUCTION

Insulin degludec/insulin aspart (IDegAsp) is a soluble combination of insulin degludec (70%) and insulin aspart (30%). The present exploratory trial investigated the safety of switching unit-to-unit from twice-daily basal or pre-mix insulin to twice-daily IDegAsp in Japanese patients with type 2 diabetes.

MATERIALS AND METHODS

In this 6-week, open-label, parallel-group, controlled trial, 66 participants were randomized (1:1) to receive either IDegAsp or biphasic insulin aspart 30 (BIAsp 30) twice daily at the same total daily dose as pre-trial insulin. During the trial, insulin doses were adjusted according to a pre-specified algorithm to achieve pre-breakfast and pre-dinner plasma glucose of 4.4-7.2 mmol/L.

RESULTS

No severe hypoglycemic episodes occurred. There were no statistically significant differences in rates of confirmed hypoglycemia (rate ratio IDegAsp/BIAsp 30: 0.63, 95% confidence interval: 0.31-1.30) and confirmed nocturnal hypoglycemia (rate ratio: 0.49, 95% confidence interval: 0.10-2.38) for IDegAsp vs BIAsp 30. The hypoglycemia rate for IDegAsp was constant over the 6 weeks of treatment. IDegAsp and BIAsp 30 were both safe and well tolerated. Reduction in fasting plasma glucose was statistically significantly greater for IDegAsp than for BIAsp 30 (estimated treatment difference, IDegAsp-BIAsp 30: -1.6 mmol/L, 95% confidence interval: -2.4 to -0.8). The apparent decrease in mean postprandial plasma glucose increment (IDegAsp: 4.2-3.8 mmol/L; BIAsp 30: 4.5-2.8 mmol/L) was not statistically significantly different between treatments (estimated treatment difference: 1.0 mmol/L, 95% confidence interval: -0.1 to 2.2).

CONCLUSIONS

Switching unit-to-unit from basal or pre-mix insulin to IDegAsp seems not to be associated with any concerns related to hypoglycemia or general safety in Japanese patients with type 2 diabetes.

Authors+Show Affiliations

The Institute for Adult Diseases, Asahi Life Foundation, Tokyo, Japan.Kenichi Yamada Internal Medicine Clinic, Miyagi, Japan.Novo Nordisk A/S, Søborg, Denmark.Novo Nordisk A/S, Søborg, Denmark.The Institute for Adult Diseases, Asahi Life Foundation, Tokyo, Japan.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

27560769

Citation

Onishi, Yukiko, et al. "Insulin Degludec/insulin Aspart Vs Biphasic Insulin Aspart 30 Twice Daily in Japanese Patients With Type 2 Diabetes: a Randomized Controlled Trial." Journal of Diabetes Investigation, vol. 8, no. 2, 2017, pp. 210-217.
Onishi Y, Yamada K, Zacho J, et al. Insulin degludec/insulin aspart vs biphasic insulin aspart 30 twice daily in Japanese patients with type 2 diabetes: A randomized controlled trial. J Diabetes Investig. 2017;8(2):210-217.
Onishi, Y., Yamada, K., Zacho, J., Ekelund, J., & Iwamoto, Y. (2017). Insulin degludec/insulin aspart vs biphasic insulin aspart 30 twice daily in Japanese patients with type 2 diabetes: A randomized controlled trial. Journal of Diabetes Investigation, 8(2), 210-217. https://doi.org/10.1111/jdi.12569
Onishi Y, et al. Insulin Degludec/insulin Aspart Vs Biphasic Insulin Aspart 30 Twice Daily in Japanese Patients With Type 2 Diabetes: a Randomized Controlled Trial. J Diabetes Investig. 2017;8(2):210-217. PubMed PMID: 27560769.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Insulin degludec/insulin aspart vs biphasic insulin aspart 30 twice daily in Japanese patients with type 2 diabetes: A randomized controlled trial. AU - Onishi,Yukiko, AU - Yamada,Kenichi, AU - Zacho,Jeppe, AU - Ekelund,Jan, AU - Iwamoto,Yasuhiko, Y1 - 2016/10/07/ PY - 2016/05/30/received PY - 2016/07/06/revised PY - 2016/08/23/accepted PY - 2016/8/26/pubmed PY - 2017/3/28/medline PY - 2016/8/26/entrez KW - Insulin degludec/insulin aspart KW - Japanese KW - Type 2 diabetes SP - 210 EP - 217 JF - Journal of diabetes investigation JO - J Diabetes Investig VL - 8 IS - 2 N2 - AIMS/INTRODUCTION: Insulin degludec/insulin aspart (IDegAsp) is a soluble combination of insulin degludec (70%) and insulin aspart (30%). The present exploratory trial investigated the safety of switching unit-to-unit from twice-daily basal or pre-mix insulin to twice-daily IDegAsp in Japanese patients with type 2 diabetes. MATERIALS AND METHODS: In this 6-week, open-label, parallel-group, controlled trial, 66 participants were randomized (1:1) to receive either IDegAsp or biphasic insulin aspart 30 (BIAsp 30) twice daily at the same total daily dose as pre-trial insulin. During the trial, insulin doses were adjusted according to a pre-specified algorithm to achieve pre-breakfast and pre-dinner plasma glucose of 4.4-7.2 mmol/L. RESULTS: No severe hypoglycemic episodes occurred. There were no statistically significant differences in rates of confirmed hypoglycemia (rate ratio IDegAsp/BIAsp 30: 0.63, 95% confidence interval: 0.31-1.30) and confirmed nocturnal hypoglycemia (rate ratio: 0.49, 95% confidence interval: 0.10-2.38) for IDegAsp vs BIAsp 30. The hypoglycemia rate for IDegAsp was constant over the 6 weeks of treatment. IDegAsp and BIAsp 30 were both safe and well tolerated. Reduction in fasting plasma glucose was statistically significantly greater for IDegAsp than for BIAsp 30 (estimated treatment difference, IDegAsp-BIAsp 30: -1.6 mmol/L, 95% confidence interval: -2.4 to -0.8). The apparent decrease in mean postprandial plasma glucose increment (IDegAsp: 4.2-3.8 mmol/L; BIAsp 30: 4.5-2.8 mmol/L) was not statistically significantly different between treatments (estimated treatment difference: 1.0 mmol/L, 95% confidence interval: -0.1 to 2.2). CONCLUSIONS: Switching unit-to-unit from basal or pre-mix insulin to IDegAsp seems not to be associated with any concerns related to hypoglycemia or general safety in Japanese patients with type 2 diabetes. SN - 2040-1124 UR - https://www.unboundmedicine.com/medline/citation/27560769/Insulin_degludec/insulin_aspart_vs_biphasic_insulin_aspart_30_twice_daily_in_Japanese_patients_with_type_2_diabetes:_A_randomized_controlled_trial_ L2 - https://doi.org/10.1111/jdi.12569 DB - PRIME DP - Unbound Medicine ER -