Comparative effects of fixed‐dose mitiglinide/voglibose combination and glimepiride on vascular endothelial function and glycemic variability in patients with type 2 diabetes: A randomized controlled trial

ABSTRACT Introduction The aim of this study was to compare the effects of mitiglinide/voglibose with those of glimepiride on glycemic variability and vascular endothelial function in patients with type 2 diabetes. Materials and Methods It was a multicenter, open‐label, randomized, crossover study. H...

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Main Authors: Kenichi Tanaka, Yosuke Okada, Saeko Umezu, Ryoma Hashimoto, Yukiko Tomoyose, Rina Tateyama, Yuri Hori, Momo Saito, Akemi Tokutsu, Satomi Sonoda, Fumi Uemura, Akira Kurozumi, Yoshiya Tanaka
Format: Article
Language:English
Published: Wiley 2024-04-01
Series:Journal of Diabetes Investigation
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Online Access:https://doi.org/10.1111/jdi.14138
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author Kenichi Tanaka
Yosuke Okada
Saeko Umezu
Ryoma Hashimoto
Yukiko Tomoyose
Rina Tateyama
Yuri Hori
Momo Saito
Akemi Tokutsu
Satomi Sonoda
Fumi Uemura
Akira Kurozumi
Yoshiya Tanaka
author_facet Kenichi Tanaka
Yosuke Okada
Saeko Umezu
Ryoma Hashimoto
Yukiko Tomoyose
Rina Tateyama
Yuri Hori
Momo Saito
Akemi Tokutsu
Satomi Sonoda
Fumi Uemura
Akira Kurozumi
Yoshiya Tanaka
author_sort Kenichi Tanaka
collection DOAJ
description ABSTRACT Introduction The aim of this study was to compare the effects of mitiglinide/voglibose with those of glimepiride on glycemic variability and vascular endothelial function in patients with type 2 diabetes. Materials and Methods It was a multicenter, open‐label, randomized, crossover study. Hospitalized patients received either mitiglinide/voglibose (three times daily administration of 10 mg mitiglinide and 0.2 mg voglibose) or glimepiride (once‐daily 2 mg) in random order, each for 5 days. The reactive hyperemia index (RHI) and the mean amplitude of glycemic excursions (MAGE) were measured as co‐primary endpoints using reactive hyperemia peripheral arterial tonometry and continuous glucose monitoring. Results The analysis included 30 patients (15 in each group). The RHI was 1.670 ± 0.369 during treatment with mitiglinide/voglibose and 1.716 ± 0.492 during treatment with glimepiride, with no significant difference between the two. MAGE was significantly lower in the mitiglinide/voglibose group (47.6 ± 18.5 mg/dL) than in the glimepiride group (100.6 ± 32.2 mg/dL). Although the mean blood glucose levels over the entire 24 h period were comparable between the two groups, the use of mitiglinide/voglibose was associated with a lower standard deviation of mean glucose, coefficient of variation, and mean postprandial glucose excursion compared with glimepiride. The time below range (<70 mg/dL) and the time above range (>180, >200, and 250 mg/dL) were lower in the mitiglinide/voglibose group, while the time in range (70–180 mg/dL) was higher. Conclusions In our short‐duration randomized crossover study, although not impacting vascular endothelial function, mitiglinide/voglibose demonstrated potential benefits in reducing glycemic variability, postprandial hyperglycemia, and hypoglycemia in patients with type 2 diabetes.
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spelling doaj.art-b579093025d24baf96230e6af49b957c2024-03-30T10:00:09ZengWileyJournal of Diabetes Investigation2040-11162040-11242024-04-0115444945810.1111/jdi.14138Comparative effects of fixed‐dose mitiglinide/voglibose combination and glimepiride on vascular endothelial function and glycemic variability in patients with type 2 diabetes: A randomized controlled trialKenichi Tanaka0Yosuke Okada1Saeko Umezu2Ryoma Hashimoto3Yukiko Tomoyose4Rina Tateyama5Yuri Hori6Momo Saito7Akemi Tokutsu8Satomi Sonoda9Fumi Uemura10Akira Kurozumi11Yoshiya Tanaka12First Department of Internal Medicine, School of Medicine University of Occupational and Environmental Health, Japan Kitakyushu JapanFirst Department of Internal Medicine, School of Medicine University of Occupational and Environmental Health, Japan Kitakyushu JapanFirst Department of Internal Medicine, School of Medicine University of Occupational and Environmental Health, Japan Kitakyushu JapanFirst Department of Internal Medicine, School of Medicine University of Occupational and Environmental Health, Japan Kitakyushu JapanFirst Department of Internal Medicine, School of Medicine University of Occupational and Environmental Health, Japan Kitakyushu JapanFirst Department of Internal Medicine, School of Medicine University of Occupational and Environmental Health, Japan Kitakyushu JapanFirst Department of Internal Medicine, School of Medicine University of Occupational and Environmental Health, Japan Kitakyushu JapanFirst Department of Internal Medicine, School of Medicine University of Occupational and Environmental Health, Japan Kitakyushu JapanFirst Department of Internal Medicine, School of Medicine University of Occupational and Environmental Health, Japan Kitakyushu JapanFirst Department of Internal Medicine, School of Medicine University of Occupational and Environmental Health, Japan Kitakyushu JapanFirst Department of Internal Medicine, School of Medicine University of Occupational and Environmental Health, Japan Kitakyushu JapanFirst Department of Internal Medicine, School of Medicine University of Occupational and Environmental Health, Japan Kitakyushu JapanFirst Department of Internal Medicine, School of Medicine University of Occupational and Environmental Health, Japan Kitakyushu JapanABSTRACT Introduction The aim of this study was to compare the effects of mitiglinide/voglibose with those of glimepiride on glycemic variability and vascular endothelial function in patients with type 2 diabetes. Materials and Methods It was a multicenter, open‐label, randomized, crossover study. Hospitalized patients received either mitiglinide/voglibose (three times daily administration of 10 mg mitiglinide and 0.2 mg voglibose) or glimepiride (once‐daily 2 mg) in random order, each for 5 days. The reactive hyperemia index (RHI) and the mean amplitude of glycemic excursions (MAGE) were measured as co‐primary endpoints using reactive hyperemia peripheral arterial tonometry and continuous glucose monitoring. Results The analysis included 30 patients (15 in each group). The RHI was 1.670 ± 0.369 during treatment with mitiglinide/voglibose and 1.716 ± 0.492 during treatment with glimepiride, with no significant difference between the two. MAGE was significantly lower in the mitiglinide/voglibose group (47.6 ± 18.5 mg/dL) than in the glimepiride group (100.6 ± 32.2 mg/dL). Although the mean blood glucose levels over the entire 24 h period were comparable between the two groups, the use of mitiglinide/voglibose was associated with a lower standard deviation of mean glucose, coefficient of variation, and mean postprandial glucose excursion compared with glimepiride. The time below range (<70 mg/dL) and the time above range (>180, >200, and 250 mg/dL) were lower in the mitiglinide/voglibose group, while the time in range (70–180 mg/dL) was higher. Conclusions In our short‐duration randomized crossover study, although not impacting vascular endothelial function, mitiglinide/voglibose demonstrated potential benefits in reducing glycemic variability, postprandial hyperglycemia, and hypoglycemia in patients with type 2 diabetes.https://doi.org/10.1111/jdi.14138continuous glucose monitoringmitiglinide/voglibose fixed‐dose combination tabletreactive hyperemia index
spellingShingle Kenichi Tanaka
Yosuke Okada
Saeko Umezu
Ryoma Hashimoto
Yukiko Tomoyose
Rina Tateyama
Yuri Hori
Momo Saito
Akemi Tokutsu
Satomi Sonoda
Fumi Uemura
Akira Kurozumi
Yoshiya Tanaka
Comparative effects of fixed‐dose mitiglinide/voglibose combination and glimepiride on vascular endothelial function and glycemic variability in patients with type 2 diabetes: A randomized controlled trial
Journal of Diabetes Investigation
continuous glucose monitoring
mitiglinide/voglibose fixed‐dose combination tablet
reactive hyperemia index
title Comparative effects of fixed‐dose mitiglinide/voglibose combination and glimepiride on vascular endothelial function and glycemic variability in patients with type 2 diabetes: A randomized controlled trial
title_full Comparative effects of fixed‐dose mitiglinide/voglibose combination and glimepiride on vascular endothelial function and glycemic variability in patients with type 2 diabetes: A randomized controlled trial
title_fullStr Comparative effects of fixed‐dose mitiglinide/voglibose combination and glimepiride on vascular endothelial function and glycemic variability in patients with type 2 diabetes: A randomized controlled trial
title_full_unstemmed Comparative effects of fixed‐dose mitiglinide/voglibose combination and glimepiride on vascular endothelial function and glycemic variability in patients with type 2 diabetes: A randomized controlled trial
title_short Comparative effects of fixed‐dose mitiglinide/voglibose combination and glimepiride on vascular endothelial function and glycemic variability in patients with type 2 diabetes: A randomized controlled trial
title_sort comparative effects of fixed dose mitiglinide voglibose combination and glimepiride on vascular endothelial function and glycemic variability in patients with type 2 diabetes a randomized controlled trial
topic continuous glucose monitoring
mitiglinide/voglibose fixed‐dose combination tablet
reactive hyperemia index
url https://doi.org/10.1111/jdi.14138
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