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Insulin degludec/insulin aspart versus biphasic insulin aspart 30 twice daily in insulin-experienced Japanese subjects with uncontrolled type 2 diabetes: Subgroup analysis of a Pan-Asian, treat-to-target Phase 3 Trial.
J Diabetes. 2017 Mar; 9(3):243-247.JD

Abstract

BACKGROUND

The present study was a subgroup analysis of a Pan-Asian Phase 3 open-label randomized treat-to-target trial evaluating insulin degludec/insulin aspart (IDegAsp) and biphasic insulin aspart 30 (BIAsp 30) in Japanese subjects with type 2 diabetes inadequately controlled on insulin.

METHODS

Eligible subjects (n = 178) were randomized (2: 1) to twice-daily (b.i.d.) IDegAsp or BIAsp 30 with or without metformin for 26 weeks, titrated to a blood glucose target of between 3.9 and <5.0 mmol/L. Changes in HbA1c , the proportion of responders reaching the HbA1c target, and changes in fasting plasma glucose, nine-point self-monitored plasma glucose profiles, and body weight were assessed.

RESULTS

At 26 weeks, the decrease in HbA1c was similar in both groups. Fasting plasma glucose was lower with IDegAsp than BIAsp 30 (estimated treatment difference -1.50 mmol/L; 95 % confidence interval [CI] -1.98, -1.01). Overall confirmed hypoglycemia rates were similar; the nocturnal confirmed hypoglycemia rate was lower with IDegAsp than BIAsp 30 (estimated rate ratio 0.44; 95 % CI 0.20, 0.99). No severe hypoglycemic episodes were reported.

CONCLUSIONS

The results indicate that IDegAsp b.i.d. improves glycemic control and, compared with BIAsp 30, lowers the rate of nocturnal confirmed hypoglycemia.

Authors+Show Affiliations

Diabetes Center, Manda Memorial Hospital, Hokkaido, Japan.Novo Nordisk Pharma Ltd, Tokyo, Japan.Novo Nordisk A/S, Sørborg, Denmark.Division of Diabetes, Endocrine and Lifestyle-related Disease, Takatsuki Red Cross Hospital, Osaka, Japan.Department of Internal Medicine, HEC Science Clinic, Yokohama, Japan.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

27059529

Citation

Taneda, Shinji, et al. "Insulin Degludec/insulin Aspart Versus Biphasic Insulin Aspart 30 Twice Daily in Insulin-experienced Japanese Subjects With Uncontrolled Type 2 Diabetes: Subgroup Analysis of a Pan-Asian, Treat-to-target Phase 3 Trial." Journal of Diabetes, vol. 9, no. 3, 2017, pp. 243-247.
Taneda S, Hyllested-Winge J, Gall MA, et al. Insulin degludec/insulin aspart versus biphasic insulin aspart 30 twice daily in insulin-experienced Japanese subjects with uncontrolled type 2 diabetes: Subgroup analysis of a Pan-Asian, treat-to-target Phase 3 Trial. J Diabetes. 2017;9(3):243-247.
Taneda, S., Hyllested-Winge, J., Gall, M. A., Kaneko, S., & Hirao, K. (2017). Insulin degludec/insulin aspart versus biphasic insulin aspart 30 twice daily in insulin-experienced Japanese subjects with uncontrolled type 2 diabetes: Subgroup analysis of a Pan-Asian, treat-to-target Phase 3 Trial. Journal of Diabetes, 9(3), 243-247. https://doi.org/10.1111/1753-0407.12407
Taneda S, et al. Insulin Degludec/insulin Aspart Versus Biphasic Insulin Aspart 30 Twice Daily in Insulin-experienced Japanese Subjects With Uncontrolled Type 2 Diabetes: Subgroup Analysis of a Pan-Asian, Treat-to-target Phase 3 Trial. J Diabetes. 2017;9(3):243-247. PubMed PMID: 27059529.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Insulin degludec/insulin aspart versus biphasic insulin aspart 30 twice daily in insulin-experienced Japanese subjects with uncontrolled type 2 diabetes: Subgroup analysis of a Pan-Asian, treat-to-target Phase 3 Trial. AU - Taneda,Shinji, AU - Hyllested-Winge,Jacob, AU - Gall,Mari-Anne, AU - Kaneko,Shizuka, AU - Hirao,Koichi, Y1 - 2016/07/07/ PY - 2015/07/31/received PY - 2016/02/08/revised PY - 2016/03/06/accepted PY - 2016/4/10/pubmed PY - 2017/6/2/medline PY - 2016/4/10/entrez KW - glycemic control KW - insulin degludec/insulin aspart KW - nocturnal hypoglycemia KW - 血糖控制,德谷胰岛素/门冬胰岛素,夜间低血糖 SP - 243 EP - 247 JF - Journal of diabetes JO - J Diabetes VL - 9 IS - 3 N2 - BACKGROUND: The present study was a subgroup analysis of a Pan-Asian Phase 3 open-label randomized treat-to-target trial evaluating insulin degludec/insulin aspart (IDegAsp) and biphasic insulin aspart 30 (BIAsp 30) in Japanese subjects with type 2 diabetes inadequately controlled on insulin. METHODS: Eligible subjects (n = 178) were randomized (2: 1) to twice-daily (b.i.d.) IDegAsp or BIAsp 30 with or without metformin for 26 weeks, titrated to a blood glucose target of between 3.9 and <5.0 mmol/L. Changes in HbA1c , the proportion of responders reaching the HbA1c target, and changes in fasting plasma glucose, nine-point self-monitored plasma glucose profiles, and body weight were assessed. RESULTS: At 26 weeks, the decrease in HbA1c was similar in both groups. Fasting plasma glucose was lower with IDegAsp than BIAsp 30 (estimated treatment difference -1.50 mmol/L; 95 % confidence interval [CI] -1.98, -1.01). Overall confirmed hypoglycemia rates were similar; the nocturnal confirmed hypoglycemia rate was lower with IDegAsp than BIAsp 30 (estimated rate ratio 0.44; 95 % CI 0.20, 0.99). No severe hypoglycemic episodes were reported. CONCLUSIONS: The results indicate that IDegAsp b.i.d. improves glycemic control and, compared with BIAsp 30, lowers the rate of nocturnal confirmed hypoglycemia. SN - 1753-0407 UR - https://www.unboundmedicine.com/medline/citation/27059529/Insulin_degludec/insulin_aspart_versus_biphasic_insulin_aspart_30_twice_daily_in_insulin_experienced_Japanese_subjects_with_uncontrolled_type_2_diabetes:_Subgroup_analysis_of_a_Pan_Asian_treat_to_target_Phase_3_Trial_ L2 - https://doi.org/10.1111/1753-0407.12407 DB - PRIME DP - Unbound Medicine ER -