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J Diabetes Investig. 2016 Jan;7(1):85-93. doi: 10.1111/jdi.12364. Epub 2015 May 25.

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.

Author information

1
China-Japan Friendship Hospital Beijing China.
2
Bethune International Peace Hospital Shijiazhuang China.
3
Affiliated Hospital of Inner Mongolia University for the Nationalities Tongliao China.
4
The Second Hospital of Jilin University Changchun China.
5
Jinan Central Hospital Affiliated to Shandong University Jinan China.
6
Anhui Provincial Hospital Hefei China.
7
Siping Central People's Hospital Siping China.
8
The Second Affiliated Hospital of Nanjing Medical University Nanjing China.
9
Chongqing Three Gorges Central Hospital Chongqing China.
10
The Third Affiliated Hospital of Hebei Medical University Shijiazhuang China.
11
The Military General Hospital of Beijing PLA Beijing China.
12
The Second Artillery General Hospital of Chinese PLA Beijing China.
13
Xijing Hospital Affiliated to 4th Military Medical University Xi'an China.
14
Peking Union Medical College Hospital Beijing China.
15
The Second Affiliated Hospital of Chongqing Medical University Chongqing China.

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 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 <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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01618214.

KEYWORDS:

Biphasic insulin aspart; Titration; Type 2 diabetes

PMID:
26816605
PMCID:
PMC4718111
DOI:
10.1111/jdi.12364
[Indexed for MEDLINE]
Free PMC Article

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