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Abstract
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.
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.
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.
Kowa Co., Ltd.
UMIN000017607.
Details
; Mita, Tomoya 2 ; Yoshii, Hidenori 3 ; Shiraiwa, Toshihiko 4 ; Yasuda, Tetsuyuki 5 ; Okada, Yosuke 6 ; Umayahara, Yutaka 7 ; Kaneto, Hideaki 8 ; Osonoi, Takeshi 9 ; Yamamoto, Tsunehiko 10 ; Kuribayashi, Nobuichi 11 ; Maeda, Kazuhisa 12 ; Yokoyama, Hiroki 13 ; Kosugi, Keisuke 14 ; Ohtoshi, Kentaro 15 ; Hayashi, Isao 16 ; Sumitani, Satoru 17 ; Tsugawa, Mamiko 18 ; Ohashi, Makoto 19 ; Taki, Hideki 20 ; Nakamura, Tadashi 21 ; Kawashima, Satoshi 22 ; Sato, Yasunori 23 ; Watada, Hirotaka 2 ; Shimomura, Iichiro 24 1 Osaka University Graduate School of Medicine, Department of Metabolic Medicine, Suita, Japan (GRID:grid.136593.b) (ISNI:0000 0004 0373 3971); Osaka University Graduate School of Medicine, Department of Metabolism and Atherosclerosis, Suita, Japan (GRID:grid.136593.b) (ISNI:0000 0004 0373 3971)
2 Juntendo University Graduate School of Medicine, Department of Metabolism and Endocrinology, Tokyo, Japan (GRID:grid.258269.2) (ISNI:0000 0004 1762 2738)
3 Juntendo Tokyo Koto Geriatric Medical Center, Department of Medicine, Diabetology and Endocrinology, Tokyo, Japan (GRID:grid.258269.2)
4 Shiraiwa Medical Clinic, Kashiwara City, Japan (GRID:grid.258269.2)
5 Osaka Police Hospital, Department of Endocrinology and Metabolism, Osaka, Japan (GRID:grid.416980.2) (ISNI:0000 0004 1774 8373)
6 University of Occupational and Environmental Health, Japan, First Department of Internal Medicine, School of Medicine, Kitakyushu, Japan (GRID:grid.271052.3) (ISNI:0000 0004 0374 5913)
7 Osaka General Medical Center, Department of Diabetes and Endocrinology, Osaka, Japan (GRID:grid.271052.3)
8 Kawasaki Medical School, Department of Diabetes, Endocrinology and Metabolism, Kurashiki, Japan (GRID:grid.415086.e) (ISNI:0000 0001 1014 2000)
9 Nakakinen Clinic, Naka City, Japan (GRID:grid.415086.e)
10 Diabetes and Endocrinology, Kansai Rosai Hospital, Amagasaki city, Japan (GRID:grid.414976.9) (ISNI:0000 0004 0546 3696)
11 Misaki Naika Clinic, Funabashi City, Japan (GRID:grid.414976.9)
12 Kitasenri Maeda Clinic, Suita, Japan (GRID:grid.414976.9)
13 Jiyugaoka Medical Clinic, Obihiro, Japan (GRID:grid.414976.9)
14 Kosugi Medical Clinic, Osaka, Japan (GRID:grid.414976.9)
15 Otoshi Medical Clinic, Osaka, Japan (GRID:grid.414976.9)
16 Hayashi Clinic, Nishinomiya, Japan (GRID:grid.414976.9)
17 Center for Diabetes and Endocrinology, Nissay Hospital, Osaka, Japan (GRID:grid.416342.6) (ISNI:0000 0004 0378 3565)
18 Ikeda Municipal Hospital, Department of Endocrinology and Metabolism, Ikeda, Japan (GRID:grid.414568.a) (ISNI:0000 0004 0604 707X)
19 Osaka Rosai Hospital, Center for Diabetes Mellitus, Sakai, Japan (GRID:grid.417001.3) (ISNI:0000 0004 0378 5245)
20 National Hospital Organization Osaka National Hospital, Diabetes Center, Osaka, Japan (GRID:grid.416803.8) (ISNI:0000 0004 0377 7966)
21 Kawasaki Hospital, Department of Internal Medicine, Hyogo, Japan (GRID:grid.415097.e) (ISNI:0000 0004 0642 2597)
22 Kanda Naika Clinic, Osaka, Japan (GRID:grid.415097.e)
23 Chiba University, Department of Global Clinical Research, Graduate School of Medicine, Chiba, Japan (GRID:grid.136304.3) (ISNI:0000 0004 0370 1101)
24 Osaka University Graduate School of Medicine, Department of Metabolic Medicine, Suita, Japan (GRID:grid.136593.b) (ISNI:0000 0004 0373 3971)