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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.
- Source :
-
Journal of diabetes investigation [J Diabetes Investig] 2016 Jan; Vol. 7 (1), pp. 85-93. Date of Electronic Publication: 2015 May 25. - 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).<br />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.<br />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.<br />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.
- Subjects :
- Adult
Blood Glucose drug effects
Blood Glucose metabolism
China epidemiology
Diabetes Mellitus, Type 2 blood
Drug Administration Schedule
Female
Humans
Male
Middle Aged
Research Personnel
Research Subjects
Asian People
Biphasic Insulins administration & dosage
Diabetes Mellitus, Type 2 drug therapy
Diabetes Mellitus, Type 2 epidemiology
Hypoglycemic Agents administration & dosage
Insulin Aspart administration & dosage
Insulin, Isophane administration & dosage
Insulin, Regular, Human administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 2040-1124
- Volume :
- 7
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Journal of diabetes investigation
- Publication Type :
- Academic Journal
- Accession number :
- 26816605
- Full Text :
- https://doi.org/10.1111/jdi.12364