Rationale and design of a multicenter randomized controlled study to evaluate the preventive effect of ipragliflozin on carotid atherosclerosis: the PROTECT study.
Abstract | BACKGROUND: 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. Trial registration Unique Trial Number, JPRN/UMIN000018440 ( https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021348 ).
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Authors | Atsushi Tanaka, Toyoaki Murohara, Isao Taguchi, Kazuo Eguchi, Makoto Suzuki, Masafumi Kitakaze, Yasunori Sato, Tomoko Ishizu, Yukihito Higashi, Hirotsugu Yamada, Mamoru Nanasato, Michio Shimabukuro, Hiroki Teragawa, Shinichiro Ueda, Satoshi Kodera, Munehide Matsuhisa, Toshiaki Kadokami, Kazuomi Kario, Yoshihiko Nishio, Teruo Inoue, Koji Maemura, Jun-Ichi Oyama, Mitsuru Ohishi, Masataka Sata, Hirofumi Tomiyama, Koichi Node, PROTECT Study Investigators |
Journal | Cardiovascular diabetology
(Cardiovasc Diabetol)
Vol. 15
Issue 1
Pg. 133
(09 13 2016)
ISSN: 1475-2840 [Electronic] England |
PMID | 27619983
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Biomarkers
- Glucosides
- Glycated Hemoglobin A
- Hypoglycemic Agents
- SLC5A2 protein, human
- Sodium-Glucose Transporter 2
- Sodium-Glucose Transporter 2 Inhibitors
- Thiophenes
- hemoglobin A1c protein, human
- ipragliflozin
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Topics |
- Adult
- Aged
- Biomarkers
(blood)
- Carotid Artery Diseases
(diagnostic imaging, etiology, prevention & control)
- Carotid Artery, Common
(diagnostic imaging, drug effects)
- Carotid Intima-Media Thickness
- Clinical Protocols
- Diabetes Mellitus, Type 2
(blood, complications, diagnosis, drug therapy)
- Diabetic Angiopathies
(diagnosis, etiology, prevention & control)
- Drug Therapy, Combination
- Female
- Glucosides
(adverse effects, therapeutic use)
- Glycated Hemoglobin
(metabolism)
- Humans
- Hypoglycemic Agents
(adverse effects, therapeutic use)
- Japan
- Male
- Middle Aged
- Prospective Studies
- Research Design
- Sodium-Glucose Transporter 2
(metabolism)
- Sodium-Glucose Transporter 2 Inhibitors
- Thiophenes
(adverse effects, therapeutic use)
- Time Factors
- Treatment Outcome
- Young Adult
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