Efficacy and Safety of Tofogliflozin and Ipragliflozin for Patients with Type-2 Diabetes: A Randomized Crossover Study b
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ORIGINAL RESEARCH
Efficacy and Safety of Tofogliflozin and Ipragliflozin for Patients with Type-2 Diabetes: A Randomized Crossover Study by Flash Glucose Monitoring Yuji Kawaguchi . Jun Sawa . Yasuro Kumeda
Received: August 1, 2020 / Accepted: October 1, 2020 Ó The Author(s) 2020
ABSTRACT Introduction: Sodium-glucose cotransporter 2 (SGLT2) inhibitors promote urinary glucose excretion. However, the differences in the effects of various SGLT2 inhibitors are unknown. We used flash glucose monitoring (FGM) to identify the differences between tofogliflozin and ipragliflozin in terms of efficacy in reducing glycemic variability and mitigate hypoglycemia risk. Methods: In this crossover study, 24 patients with type-2 diabetes mellitus (T2DM) receiving insulin glargine U300 therapy were randomly allocated to tofogliflozin and ipragliflozin or ipragliflozin and tofogliflozin group. Glycemic variability and hypoglycemia were compared using to the 3-day FGM data per treatment period.
Electronic Supplementary Material The online version of this article (https://doi.org/10.1007/s13300020-00940-9) contains supplementary material, which is available to authorized users. Y. Kawaguchi (&) J. Sawa Y. Kumeda Department of Internal Medicine, Minami Osaka Hospital, 1-18-18, Higashikagaya, Suminoe-ku, Osaka 559-0012, Japan e-mail: [email protected]
Results: Glucose level 2 h after each meal was significantly lower with tofogliflozin administration than with ipragliflozin administration. Time below the target glucose range after tofogliflozin administration was significantly lower than that after ipragliflozin administration (2.1% ± 4.4% vs. 8.7% ± 11.7%). The 24-h standard deviation of glucose level, mean amplitude of glycemic excursion, and mean percent time with nocturnal hypoglycemia after tofogliflozin administration were significantly lower than those after ipragliflozin administration. Conclusions: Tofogliflozin was more effective and safer than ipragliflozin in reducing glycemic variability and mitigating hypoglycemia risk in patients with T2DM treated with insulin glargine U300. Trial Registration: This trial was registered at the University Hospital Medical Information Network Clinical Trial Registry (no. UMIN000037158). Keywords: Glycemic Hypoglycemia; Tofogliflozin
variability;
Diabetes Ther
Key Summary Points Why carry out this study? Sodium-glucose cotransporter 2 (SGLT2) inhibitors promote urinary glucose excretion. The differences in the effects of various SGLT2 inhibitors are unknown. Flash glucose monitoring (FGM) was used to identify the differences in efficacy between tofogliflozin and ipragliflozin treatments. What was learned from the study? Data collected using FGM demonstrated that tofogliflozin was more effective and safer than ipragliflozin in reducing diurnal glycemic variability and lowering the risk of nocturnal hypoglycemia. The risk of cardiovascular disease was higher in patients with advanced renal dysfunction; it is unclear whether SGLT2 inhibitors can reduce the risk of cardiovas
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