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
| Autor: | Wenhui Wang, Wenying Yang, Gangyi Yang, Yu Liu, Zhanjian Wang, Lvyun Zhu, Shandong Ye, Heng Miao, Weigang Zhao, Qiuhe Ji, Li'an Guo, Xiaofeng Lv, Li Sun, Bangzhu Meng, Quanmin Li |
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| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
Adult
Blood Glucose Male medicine.medical_specialty China Research Subjects Endocrinology Diabetes and Metabolism Insulin Isophane 030209 endocrinology & metabolism Type 2 diabetes Biphasic Insulins Biphasic insulin aspart Drug Administration Schedule Insulin aspart 03 medical and health sciences 0302 clinical medicine Asian People Diabetes mellitus Multicenter trial Internal medicine Insulin Regular Human Internal Medicine medicine Humans Hypoglycemic Agents 030212 general & internal medicine Insulin Aspart business.industry General Medicine Articles Middle Aged medicine.disease Research Personnel Surgery Clinical Science and Care Titration Diabetes Mellitus Type 2 Original Article Female Open label business medicine.drug |
| Zdroj: | Journal of Diabetes Investigation |
| ISSN: | 2040-1124 2040-1116 |
| Popis: | 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 investigator‐driven 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 subject‐titration 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 |
| Databáze: | OpenAIRE |
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