Tanaka, Atsushi Saga University
Murohara, Toyoaki Nagoya University
Taguchi, Isao Dokkyo Medical University
Eguchi, Kazuo Jichi Medical University
Suzuki, Makoto Kameda Medical Center
Kitakaze, Masafumi National Cerebral and Cardiovascular Center
Sato, Yasunori Chiba University
Ishizu, Tomoko University of Tsukuba
Higashi, Yukihito Hiroshima University
Nanasato, Mamoru Japanese Red Cross Nagoya Daini Hospital
Teragawa, Hiroki JR Hiroshima Hospital
Ueda, Shinichiro University of the Ryukyus
Kodera, Satoshi Asahi General Hospital
Kadokami, Toshiaki Saiseikai Futsukaichi Hospital
Kario, Kazuomi Jichi Medical University
Nishio, Yoshihiko Kagoshima University
Inoue, Teruo Dokkyo Medical University
Maemura, Koji Nagasaki University
Oyama, Jun‑ichi Saga University
Ohishi, Mitsuru Kagoshima University
Tomiyama, Hirofumi Tokyo Medical University
Node, Koichi Saga University
Intima-media thickness (IMT)
Type 2 diabetes mellitus
Background: Type 2 diabetes mellitus is associated strongly with an increased risk of micro- and macro-vascular complications, leading to impaired quality of life and shortened life expectancy. In addition to appropriate glycemic control, multi-factorial intervention for a wide range of risk factors, such as hypertension and dyslipidemia, is crucial for management of diabetes. A recent cardiovascular outcome trial in diabetes patients with higher cardiovascular risk demonstrated that a SGLT2 inhibitor markedly reduced mortality, but not macro-vascular events. However, to date there is no clinical evidence regarding the therapeutic effects of SGLT2 inhibitors on arteriosclerosis. The ongoing PROTECT trial was designed to assess whether the SGLT2 inhibitors, ipragliflozin, prevented progression of carotid intima-media thickness in Japanese patients with type 2 diabetes mellitus.
Methods: A total of 480 participants with type 2 diabetes mellitus with a HbA1c between 6 and 10 % despite receiving diet/exercise therapy and/or standard anti-diabetic agents for at least 3 months, will be randomized systematically (1:1) into either ipragliflozin or control (continuation of conventional therapy) groups. After randomization, ipragliflozin (50–100 mg once daily) will be added on to the background therapy in participants assigned to the ipragliflozin group. The primary endpoint of the study is the change in mean intima-media thickness of the common carotid artery from baseline to 24 months. Images of carotid intima-media thickness will be analyzed at a central core laboratory in a blinded manner. The key secondary endpoints include the change from baseline in other parameters of carotid intima-media thickness, various metabolic parameters, and renal function. Other cardiovascular functional tests are also planned for several sub-studies.
Discussion: The PROTECT study is the first to assess the preventive effect of ipragliflozin on progression of carotid atherosclerosis using carotid intima-media thickness as a surrogate marker. The study has potential to clarify the protective effects of ipragliflozin on atherosclerosis.
Springer Nature|BioMed Central
© 2016 The Author(s). This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
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