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Katakami N, Mita T, Yoshii H, et al. 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. Diabetes Ther. 2017;8(5):999-1013doi: 10.1007/s13300-017-0292-1.
Katakami, N., Mita, T., Yoshii, H., Shiraiwa, T., Yasuda, T., Okada, Y., Umayahara, Y., Kaneto, H., Osonoi, T., Yamamoto, T., Kuribayashi, N., Maeda, K., Yokoyama, H., Kosugi, K., Ohtoshi, K., Hayashi, I., Sumitani, S., Tsugawa, M., Ohashi, M., Taki, H., Nakamura, T., Kawashima, S., Sato, Y., Watada, H., Shimomura, I. (2017). 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. Diabetes therapy : research, treatment and education of diabetes and related disorders, 8(5), 999-1013. https://doi.org/10.1007/s13300-017-0292-1
Katakami, Naoto, et al. "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." Diabetes therapy : research, treatment and education of diabetes and related disorders vol. 8,5 (2017): 999-1013. doi: https://doi.org/10.1007/s13300-017-0292-1
Katakami N, Mita T, Yoshii H, Shiraiwa T, Yasuda T, Okada Y, Umayahara Y, Kaneto H, Osonoi T, Yamamoto T, Kuribayashi N, Maeda K, Yokoyama H, Kosugi K, Ohtoshi K, Hayashi I, Sumitani S, Tsugawa M, Ohashi M, Taki H, Nakamura T, Kawashima S, Sato Y, Watada H, Shimomura I. 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. Diabetes Ther. 2017 Oct;8(5):999-1013. doi: 10.1007/s13300-017-0292-1. Epub 2017 Sep 01. PMID: 28864997; PMCID: PMC5630549.
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Diabetes Ther. 2017 Oct;8(5):999-1013. doi: 10.1007/s13300-017-0292-1. Epub 2017 Sep 01.

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.

Diabetes therapy : research, treatment and education of diabetes and related disorders

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,

Affiliations

  1. Department of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan. [email protected].
  2. Department of Metabolism and Atherosclerosis, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan. [email protected].
  3. Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Hongo 2-1-1, Bunkyo-ku, Tokyo, 113-8421, Japan.
  4. Department of Medicine, Diabetology and Endocrinology, Juntendo Tokyo Koto Geriatric Medical Center, Koto-ku, Tokyo, 136-0075, Japan.
  5. Shiraiwa Medical Clinic, 4-10-24 Hozenji, Kashiwara City, Osaka, 582-0005, Japan.
  6. Department of Endocrinology and Metabolism, Osaka Police Hospital, 10-31, Kitayama-cho, Tennoji-ku, Osaka, 543-0035, Japan.
  7. First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, 1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan.
  8. Department of Diabetes and Endocrinology, Osaka General Medical Center, 3-1-56, Bandai-Higashi, Sumiyoshi-ku, Osaka, 558-8558, Japan.
  9. Department of Diabetes, Endocrinology and Metabolism, Kawasaki Medical School, 577 Matsushima, Kurashiki, Okayama, 701-0192, Japan.
  10. Nakakinen Clinic, 745-5, Nakadai, Naka City, Ibaraki, 311-0113, Japan.
  11. Diabetes and Endocrinology, Kansai Rosai Hospital, 3-1-69, Inabaso, Amagasaki city, Hyogo, Japan.
  12. Misaki Naika Clinic, 6-44-9, Futawa-higashi, Funabashi City, Chiba, Japan.
  13. Kitasenri Maeda Clinic, 4-119, Furuedai, Suita, Osaka, 565-0874, Japan.
  14. Jiyugaoka Medical Clinic, West 6, South 6-4-3, Obihiro, Hokkaido, 080-0016, Japan.
  15. Kosugi Medical Clinic, 3-9, Tamatsukurimoto-cho, Tennoji-ku, Osaka, 543-0014, Japan.
  16. Otoshi Medical Clinic, 8-47, Kakudacho, Osaka Kita-ku, Osaka, 530-0017, Japan.
  17. Hayashi Clinic, 3-9-23 Koshienguchi, Nishinomiya, Hyogo, 663-8113, Japan.
  18. Center for Diabetes and Endocrinology, Nissay Hospital, 6-3-8, Itachibori, Nishi-ku, Osaka, 550-0012, Japan.
  19. Department of Endocrinology and Metabolism, Ikeda Municipal Hospital, 3-1-18, Jonan, Ikeda, Osaka, 563-8510, Japan.
  20. Center for Diabetes Mellitus, Osaka Rosai Hospital, 1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka, 591-8025, Japan.
  21. Diabetes Center, National Hospital Organization Osaka National Hospital, 2-1-14, Hoenzaka, Chuo-ku, Osaka, 540-0006, Japan.
  22. Department of Internal Medicine, Kawasaki Hospital, 3-3-1, Higashiyamacho, Kobe Hyogo-ku, Hyogo, 652-0042, Japan.
  23. Kanda Naika Clinic, 5-21-3, Hannancho, Osaka Abeno-ku, Osaka, 545-0021, Japan.
  24. Department of Global Clinical Research, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba, 260-8677, Japan.
  25. Department of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.

PMID: 28864997 PMCID: PMC5630549 DOI: 10.1007/s13300-017-0292-1

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.

Keywords: Atherosclerosis; Diabetes; Intima-media thickness; SGLT2 inhibitor; Tofogliflozin

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