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Influence of Fasting Plasma Glucose Targets on Glycemic Variability in Chinese Participants With Type 2 Diabetes: A Post Hoc Analysis of the FPG GOAL Trial (BEYOND III)

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Abstract

Introduction

This post hoc analysis examines the relationship between glycemic variability (GV) and fasting plasma glucose (FPG) targets used to achieve glycated hemoglobin (HbA1c) < 7%, and HbA1c levels after 24 weeks of treatment with insulin glargine and oral antidiabetic drugs (OADs) in Chinese participants with type 2 diabetes mellitus (T2DM) from the BEYOND III FPG GOAL trial (NCT02545842).

Methods

Participants were randomized for three FBG targets (≤ 5.6 mmol/L, ≤ 6.1 mmol/L, and ≤ 7.0 mmol/L) receiving insulin glargine 100 U/mL were analyzed for mean change from baseline to 24 weeks in postprandial glucose (PPG) excursion and FPG coefficient of variation (FPG-CV). The study analyzed change from baseline in HbA1c and the proportion of participants who achieved HbA1c < 7% at 24 weeks, according to their baseline FPG-CV and change from baseline in PPG excursion.

Results

The change in PPG excursion and FPG-CV from baseline to 24 weeks was not significantly different between the three groups stratified by randomization or by 24-week FPG levels. While the change in HbA1c from baseline to 24 weeks was slightly higher among participants with baseline FPG-CV < 33.3% (vs. > 66.7%; P = 0.023), a higher proportion of participants with baseline FPG-CV < 33.3% achieved HbA1c < 7% (P = 0.021).

Conclusions

GV was not associated with either target FPG levels or HbA1c < 7.0% after 24 weeks of treatment with insulin glargine and OADs.

Trial Registration

Clinicaltrials.gov identifier NCT02545842.

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Acknowledgements

Funding

This study was funded by Sanofi including the journal’s Rapid Service Fee.

Medical Writing and Editorial Assistance

Editorial assistance in the preparation of this article was provided by Nishad Parkar, PhD, of inScience Communications Springer Healthcare and Anwesha Mandal and Dr G. Kaushik Subramanian of Indegene Pvt. Ltd., Bangalore, India. Support for this medical writing assistance was funded by Sanofi.

Authorship

All named authors met the International Committee of Medical Journal Editors criteria for authorship of this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Authors’ Contributions

The study was designed by Wenying Yang. Ling Li, Tao Yang, Yaoming Xue, and Wenying Yang supervised individual study centers, recruited participants, and conducted the study. Yunguang Li, Xia Zhang, and Nan Cui participated in the study design and coordination between study centers. Juan Du coordinated the manuscript development process, reviewed and proofread the contents, and adjusted the structure. All authors contributed to writing and reviewing the manuscript before submission. Wenying Yang is the guarantor for this manuscript.

Disclosures

Ling Li, Tao Yang, Yaoming Xue, and Wenying Yang have received honoraria for speakers’ bureau and advisory board participation from Sanofi Aventis, Novo Nordisk, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Merck Sharp & Dohme, Merck, and Servier. Wenying Yang has also received investigator-initiated trial research grants from AstraZeneca outside of the submitted work. Pengfei Ruan, Juan Du, Yunguang Li, Xia Zhang, and Nan Cui are employees of Sanofi China.

Compliance with Ethics Guidelines

The study was conducted in accordance with the principles stated in the Declaration of Helsinki and in line with the International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines for good clinical practice. An institutional review board at each site approved the study. All study participants provided written informed consent before study commencement.

Data Availability

Qualified researchers may request access to patient-level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and data set specifications. Patient-level data will be anonymized, and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi’s data sharing criteria, eligible studies, and process for requesting access can be found at https://www.clinicalstudydatarequest.com.

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Authors and Affiliations

  1. Shengjing Hospital of China Medical University, Shenyang, China

    Ling Li

  2. Jiangsu Province Hospital, Nanjing, China

    Tao Yang

  3. Nanfang Hospital, Guangzhou, China

    Yaoming Xue

  4. Sanofi Investment Co., Ltd., Shanghai, China

    Pengfei Ruan, Juan Du, Yunguang Li, Xia Zhang & Nan Cui

  5. China-Japan Friendship Hospital, East Yinghuayuan Street, Hepingli, Beijing, 100029, People’s Republic of China

    Wenying Yang

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  1. Ling Li
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Correspondence to Wenying Yang.

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Li, L., Yang, T., Xue, Y. et al. Influence of Fasting Plasma Glucose Targets on Glycemic Variability in Chinese Participants With Type 2 Diabetes: A Post Hoc Analysis of the FPG GOAL Trial (BEYOND III). Adv Ther 39, 421–429 (2022). https://doi.org/10.1007/s12325-021-01932-2

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  • DOI: https://doi.org/10.1007/s12325-021-01932-2

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