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Diabetes Therapy
Published in: Diabetes Therapy 5/2017

Open Access 01-10-2017 | Original Research

Rationale, Design, and Baseline Characteristics of the Utopia Trial for Preventing Diabetic Atherosclerosis Using an SGLT2 Inhibitor: A Prospective, Randomized, Open-Label, Parallel-Group Comparative Study

Authors: Naoto Katakami, Tomoya Mita, Hidenori Yoshii, Toshihiko Shiraiwa, Tetsuyuki Yasuda, Yosuke Okada, Yutaka Umayahara, Hideaki Kaneto, Takeshi Osonoi, Tsunehiko Yamamoto, Nobuichi Kuribayashi, Kazuhisa Maeda, Hiroki Yokoyama, Keisuke Kosugi, Kentaro Ohtoshi, Isao Hayashi, Satoru Sumitani, Mamiko Tsugawa, Makoto Ohashi, Hideki Taki, Tadashi Nakamura, Satoshi Kawashima, Yasunori Sato, Hirotaka Watada, Iichiro Shimomura, On behalf of the UTOPIA study investigators

Published in: Diabetes Therapy | Issue 5/2017

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Abstract

Introduction

Sodium-glucose co-transporter-2 (SGLT2) inhibitors are anti-diabetic agents that improve glycemic control with a low risk of hypoglycemia and ameliorate a variety of cardiovascular risk factors. The aim of the ongoing study described herein is to investigate the preventive effects of tofogliflozin, a potent and selective SGLT2 inhibitor, on the progression of atherosclerosis in subjects with type 2 diabetes (T2DM) using carotid intima-media thickness (IMT), an established marker of cardiovascular disease (CVD), as a marker.

Methods

The Study of Using Tofogliflozin for Possible better Intervention against Atherosclerosis for type 2 diabetes patients (UTOPIA) trial is a prospective, randomized, open-label, blinded-endpoint, multicenter, and parallel-group comparative study. The aim was to recruit a total of 340 subjects with T2DM but no history of apparent CVD at 24 clinical sites and randomly allocate these to a tofogliflozin treatment group or a conventional treatment group using drugs other than SGLT2 inhibitors. As primary outcomes, changes in mean and maximum IMT of the common carotid artery during a 104-week treatment period will be measured by carotid echography. Secondary outcomes include changes in glycemic control, parameters related to β-cell function and diabetic nephropathy, the occurrence of CVD and adverse events, and biochemical measurements reflecting vascular function.

Conclusion

This is the first study to address the effects of SGLT2 inhibitors on the progression of carotid IMT in subjects with T2DM without a history of CVD. The results will be available in the very near future, and these findings are expected to provide clinical data that will be helpful in the prevention of diabetic atherosclerosis and subsequent CVD.

Funding

Kowa Co., Ltd.

Clinical Trial Registration

UMIN000017607.
Appendix
Available only for authorised users
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Metadata
Title
Rationale, Design, and Baseline Characteristics of the Utopia Trial for Preventing Diabetic Atherosclerosis Using an SGLT2 Inhibitor: A Prospective, Randomized, Open-Label, Parallel-Group Comparative Study
Authors
Naoto Katakami
Tomoya Mita
Hidenori Yoshii
Toshihiko Shiraiwa
Tetsuyuki Yasuda
Yosuke Okada
Yutaka Umayahara
Hideaki Kaneto
Takeshi Osonoi
Tsunehiko Yamamoto
Nobuichi Kuribayashi
Kazuhisa Maeda
Hiroki Yokoyama
Keisuke Kosugi
Kentaro Ohtoshi
Isao Hayashi
Satoru Sumitani
Mamiko Tsugawa
Makoto Ohashi
Hideki Taki
Tadashi Nakamura
Satoshi Kawashima
Yasunori Sato
Hirotaka Watada
Iichiro Shimomura
On behalf of the UTOPIA study investigators
Publication date
01-10-2017
Publisher
Springer Healthcare
Published in
Diabetes Therapy / Issue 5/2017
Print ISSN: 1869-6953
Electronic ISSN: 1869-6961
DOI
https://doi.org/10.1007/s13300-017-0292-1

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