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Aims/Introduction  The present study was to compare the efficacy and safety of subject‐driven and investigator‐driven titration of biphasic insulin aspart 30 ( BIA sp 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  BIA sp 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 (HbA 1c ) 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 HbA 1c  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 HbA 1c  <53.0 mmol/mol (7.0%), and 51.2 and 45.9% patients achieving the HbA 1c  target without confirmed hypoglycemia throughout the trial in the subject‐driven and investigator‐driven groups, respectively.    Conclusions  Subject‐titration of  BIA sp 30  BID  was as efficacious and well‐tolerated as investigator‐titration. The present study supported patients to self‐titrate  BIA sp 30  BID  under physicians’ supervision.

journal of diabetes investigation

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