Clinical Trials Study
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Diabetes. Jan 15, 2025; 16(1): 95209
Published online Jan 15, 2025. doi: 10.4239/wjd.v16.i1.95209
Efficacy, safety and treatment satisfaction of transition to a regimen of insulin degludec/aspart: A pilot study
Na Yang, Lu Lv, Shu-Meng Han, Li-Yun He, Zi-Yi Li, Yu-Cheng Yang, Fan Ping, Ling-Ling Xu, Wei Li, Hua-Bing Zhang, Yu-Xiu Li
Na Yang, Shu-Meng Han, Li-Yun He, Zi-Yi Li, Yu-Cheng Yang, Fan Ping, Ling-Ling Xu, Wei Li, Hua-Bing Zhang, Yu-Xiu Li, Department of Endocrinology, Key Laboratory of Endocrinology of National Health Commission, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China
Lu Lv, Department of Allergy, Beijing Key Laboratory of Precision Medicine for Diagnosis and Treatment of Allergic Diseases, National Clinical Research Center for Dermatologic and Immunologic Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing 100730, China
Co-corresponding authors: Hua-Bing Zhang and Yu-Xiu Li.
Author contributions: Zhang HB, Li YX participated in the conceptualization, data curation, investigation, methodology, project administration, resources, and supervision; Yang N was involved in the formal analysis and writing of the original draft; Lv L, Han SM, He LY, Li ZY, Yang YC were involved in the formal analysis; Ping F, Xu LL, Li W were involved in writing-review and editing.
Supported by CAMS Innovation Fund for Medical Sciences, No. 2023-I2M-C&T-B-043; National High Level Hospital Clinical Research Funding, No. 2022-PUMCH-B-015; CAMS Innovation Fund for Medical Sciences, No. 2021-1-12M-002; and Beijing Municipal Natural Science Foundation, No. M22014.
Institutional review board statement: The study was reviewed and approved by Peking Union Medical College Hospital Institutional Review Board (Approval No. HS-2449).
Clinical trial registration statement: This study is registered at chictr.org.cn. The registration identification number is CHICTR2000037600.
Informed consent statement: All study participants provided informed written consent prior to study enrollment.
Conflict-of-interest statement: The authors declare no conflicts of interest.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Hua-Bing Zhang, MD, Chief Doctor, Department of Endocrinology, Key Laboratory of Endocrinology of National Health Commission, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 1 Shuaifuyuan, Wangfujing Street, Beijing 100730, China. huabingzhangchn@163.com
Received: April 4, 2024
Revised: September 19, 2024
Accepted: October 8, 2024
Published online: January 15, 2025
Processing time: 239 Days and 19.2 Hours
Abstract
BACKGROUND

There is a lack of clinical evidence on the efficacy and safety of transitioning from a thrice-daily pre-mixed insulin or basal-prandial regimen to insulin deglu-dec/aspart (IDegAsp) therapy, with insufficient data from the Chinese popu-lation.

AIM

To demonstrate the efficacy, safety, and treatment satisfaction associated with the transition to IDegAsp in type 2 diabetes mellitus (T2DM).

METHODS

In this 12-week open-label, non-randomized, single-center, pilot study, patients with T2DM receiving thrice-daily insulin or intensive insulin treatment were transitioned to twice-daily injections of insulin IDegAsp. Insulin doses, hemoglobin A1c (HbA1c) levels, fasting blood glucose (FBG), hypoglycemic events, a Diabetes Treatment Satisfaction Questionnaire, and other parameters were assessed at baseline and 12-weeks.

RESULTS

This study included 21 participants. A marked enhancement was observed in the FBG level (P = 0.02), daily total insulin dose (P = 0.03), and overall diabetes treatment satisfaction (P < 0.01) in the participants who switched to IDegAsp. There was a decrease in HbA1c levels (7.6 ± 1.1 vs 7.4 ± 0.9, P = 0.31) and the frequency of hypoglycemic events of those who switched to IDegAsp decreased, however, there was no statistically significant difference.

CONCLUSION

The present findings suggest that treatment with IDegAsp enhances clinical outcomes, particularly FBG levels, daily cumulative insulin dose, and overall satisfaction with diabetes treatment.

Keywords: Insulin degludec/aspart; Type 2 diabetes management; Basal-bolus insulin therapy; Pre-mixed insulin; Diabetes treatment satisfaction questionnaire

Core Tip: This study aimed to prospectively assess the efficacy, safety, and treatment satisfaction of switching from thrice-daily pre-mixed insulin or basal-bolus insulin to a twice-daily insulin degludec/aspart (IDegAsp) regimen in Chinese patients with type 2 diabetes mellitus. The results demonstrated significant improvements in fasting blood glucose levels, reduction in total insulin dosage, and enhanced patient satisfaction. These findings suggest that IDegAsp simplifies insulin therapy while maintaining effective glycemic control, thereby offering a promising alternative for optimizing diabetes management in this population.