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Subject-driven titration of biphasic insulin aspart 30 twice daily is non-inferior to investigator-driven titration in Chinese patients with type 2 diabetes inadequately controlled with premixed human insulin: A randomized, open-label, parallel-group, multicenter trial

Authors :
Yang, Wenying
Zhu, Lvyun
Meng, Bangzhu
Liu, Yu
Wang, Wenhui
Ye, Shandong
Sun, Li
Miao, Heng
Guo, Lian
Wang, Zhanjian
Lv, Xiaofeng
Li, Quanmin
Ji, Qiuhe
Zhao, Weigang
Yang, Gangyi
Source :
Journal of Diabetes Investigation. Jan2016, Vol. 7 Issue 1, p85-93. 9p.
Publication Year :
2016

Abstract

Aims/Introduction: The present study was to compare the efficacy and safety of subject- driven and investigator-driven titration of biphasic insulin aspart 30 (BIAsp 30) twice daily (BID). Materials and Methods: In this 20-week, randomized, open-label, two-group parallel, multicenter trial, Chinese patients with type 2 diabetes inadequately controlled by premixed/ self-mixed human insulin were randomized 1:1 to subject-driven or investigatordriven titration of BIAsp 30 BID, in combination with metformin and/or α-glucosidase inhibitors. Dose adjustment was decided by patients in the subject-driven group after training, and by investigators in the investigator-driven group. Results: Eligible adults (n = 344) were randomized in the study. The estimated glycated hemoglobin (HbA1c) reduction was 14.5 mmol/mol (1.33%) in the subject-driven group and 14.3 mmol/mol (1.31%) in the investigator-driven group. Non-inferiority of subjecttitration vs investigator-titration in reducing HbA1c was confirmed, with estimated treatment difference -0.26 mmol/mol (95% confidence interval -2.05, 1.53) (-0.02%, 95% confidence interval -0.19, 0.14). Fasting plasma glucose, postprandial glucose increment and self-measured plasma glucose were improved in both groups without statistically significant differences. One severe hypoglycemic event was experienced by one subject in each group. A similar rate of nocturnal hypoglycemia (events/patient-year) was reported in the subject-driven (1.10) and investigator-driven (1.32) groups. There were 64.5 and 58.1% patients achieving HbA1c <53.0 mmol/mol (7.0%), and 51.2 and 45.9% patients achieving the HbA1c target without confirmed hypoglycemia throughout the trial in the subject-driven and investigator-driven groups, respectively. Conclusions: Subject-titration of BIAsp 30 BID was as efficacious and well-tolerated as investigator-titration. The present study supported patients to self-titrate BIAsp 30 BID under physicians' supervision. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
20401116
Volume :
7
Issue :
1
Database :
Academic Search Index
Journal :
Journal of Diabetes Investigation
Publication Type :
Academic Journal
Accession number :
112227546
Full Text :
https://doi.org/10.1111/jdi.12364