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Influence of Fasting Glucose Levels on Achieving Glycemic Target in Individuals with Type 2 Diabetes: a Post Hoc Analysis

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Abstract

Introduction

FPG GOAL was a 24-week, open-label, treat-to-target randomized controlled trial which demonstrated that the optimal self-monitored fasting blood glucose (SM-FBG) target for most Chinese individuals with type 2 diabetes (T2D) using insulin glargine 100 IU/mL was 3.9–6.1 mmol/L. Individuals who achieved lower fasting plasma glucose (FPG) levels might achieve the target HbA1c of < 7% without increasing the risk of hypoglycemia.

Methods

For this post hoc analysis, individuals were redivided into three groups based on their actual laboratory FPG levels at 24 weeks: level 1, ≤ 5.6 mmol/L; level 2, > 5.6 to ≤ 6.1 mmol/L; and level 3, > 6.1 to ≤ 7.0 mmol/L.

Results

At week 24, 863 individuals with diabetes had available FPG data and 179, 122, and 179 individuals achieved FPG levels 1, 2, and 3, respectively. The proportion of individuals with HbA1c < 7% or HbA1c < 7% without hypoglycemia (≤ 3.9 or ≤ 3.0 mmol/L) was significantly higher in FPG levels 1 (p < 0.01) and 2 (p < 0.05) than in level 3. The least squares mean changes from baseline in HbA1c (− 1.77% and − 1.66% vs − 1.34%; both p < 0.001) and 2-h postprandial glucose (− 3.88 mmol/L and − 3.98 mmol/L vs − 3.22 mmol/L; both p < 0.05) were also significantly higher in FPG levels 1 and 2 compared with level 3. Linear regression analysis showed a moderate relationship between FPG and HbA1c levels at 24 weeks (r = 0.449).

Conclusions

Chinese individuals with T2D who achieved lower FPG levels with insulin glargine 100 IU/mL were more likely to achieve the recommended target HbA1c of < 7% compared with those with higher FPG levels. ClinicalTrials.gov identifier NCT02545842.

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Acknowledgements

The authors thank the participants included in the study.

Funding

This study and the journal's rapid service fee were funded by Sanofi.

Authorship

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

Authorship Contributions

The study was designed by Wenying Yang, Jianhua Ma, and Minxiang Lei who were in charge of individual study centers, recruited patients, and conducted the study. Yunguang Li, Xia Zhang, and Nan Cui participated in study design and coordinated between study centers. All authors contributed to writing and reviewing the manuscript before submission. Wenying Yang is the guarantor for this manuscript.

Medical Writing and Editorial Assistance

The authors would like to thank Nishad Parkar, PhD, of inScience Communications, Springer Healthcare, for writing the outline and the subsequent drafts of this manuscript. This medical writing assistance was funded by Sanofi.

Disclosures

Wenying Yang has received honoraria for speakers’ bureau and advisory board participation from Sanofi Aventis, Novo Nordisk, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lily, Merck Sharp & Dohme, Merck, and Servier and has also received investigator-initiated trial research grants from AstraZeneca outside of the submitted work. Jianhua Ma and Minxiang Lei have no conflicts of interest to disclose. 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 Conference on Harmonization Guidelines for Good Clinical Practice. An institutional review board at each site approved the study, and all participants gave written informed consent to participate. The study protocol and the informed consent to participate were reviewed and approved by China-Japan Friendship Hospital Ethics Committee.

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 dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of our 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/.

Author information

Authors and Affiliations

  1. Nanjing First Hospital, Nanjing, China

    Jianhua Ma

  2. Xiangya Hospital Central South University, Changsha, China

    Minxiang Lei

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

    Yunguang Li, Xia Zhang & Nan Cui

  4. China-Japan Friendship Hospital, Beijing, China

    Wenying Yang

Authors
  1. Jianhua Ma
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  2. Minxiang Lei
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  3. Yunguang Li
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  4. Xia Zhang
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  5. Nan Cui
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  6. Wenying Yang
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Corresponding author

Correspondence to Wenying Yang.

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Ma, J., Lei, M., Li, Y. et al. Influence of Fasting Glucose Levels on Achieving Glycemic Target in Individuals with Type 2 Diabetes: a Post Hoc Analysis. Adv Ther 37, 3816–3826 (2020). https://doi.org/10.1007/s12325-020-01410-1

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