Effect of dapagliflozin as an add-on therapy to insulin on the glycemic variability in subjects with type 2 diabetes mellitus (DIVE): A Multicenter, Placebo-Controlled, Double-Blind, Randomized Study

Seung Hwan Lee, Kyung Wan Min, Byung Wan Lee, In Kyung Jeong, Soon Jib Yoo, Hyuk Sang Kwon, Yoon Hee Choi, Kun Ho Yoon

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2 Citations (Scopus)

Abstract

Background: Glycemic variability is associated with the development of diabetic complications and hypoglycemia. However, the effect of sodium-glucose transporter 2 (SGLT2) inhibitors on glycemic variability is controversial. We aimed to examine the effect of dapagliflozin as an add-on therapy to insulin on the glycemic variability assessed using continuous glucose monitoring (CGM) in subjects with type 2 diabetes mellitus. Methods: In this multicenter, placebo-controlled, double-blind, randomized study, 84 subjects received 10 mg of dapagliflozin (n=41) or the placebo (n=43) for 12 weeks. CGM was performed before and after treatment to compare the changes in glycemic variability measures (standard deviation [SD], mean amplitude of glycemic excursions [MAGEs]). Results: At week 12, significant reductions in glycosylated hemoglobin (–0.74%±0.66% vs. 0.01%±0.65%, P<0.001), glycated albumin (–3.94%±2.55% vs. –0.67%±2.48%, P<0.001), and CGM-derived mean glucose (–41.6±39.2 mg/dL vs. 1.1±46.2 mg/dL, P<0.001) levels were observed in the dapagliflozin group compared with the placebo group. SD and MAGE were significantly decreased in the dapagliflozin group, but not in the placebo group. However, the difference in ΔSD and ΔMAGE failed to reach statistical significance between two groups. No significant differences in the incidence of safety endpoints were observed between the two groups. Conclusion: Dapagliflozin effectively decreased glucose levels, but not glucose variability, after 12 weeks of treatment in participants with type 2 diabetes mellitus receiving insulin treatment. The role of SGLT2 inhibitors in glycemic variability warrants further investigations.

Original languageEnglish
Pages (from-to)339-348
Number of pages10
JournalDiabetes and Metabolism Journal
Volume45
Issue number3
DOIs
Publication statusPublished - 2021 May

Bibliographical note

Funding Information:
This work was supported by an AstraZeneca Ltd. investigator initiated study grant. The funder had no role in study design, data collection and analysis, interpretation of the data, decision to publish, or preparation of the manuscript. The funder had the opportunity to review the final manuscript prior to submission. The corresponding author had full access to all the data in the study and final responsibility for the decision to submit for publication

Publisher Copyright:
Copyright © 2021 Korean Diabetes Association.

All Science Journal Classification (ASJC) codes

  • Endocrinology, Diabetes and Metabolism

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