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Diabetes and endocrinology
Protocol
Efficacy and safety of ipragliflozin and metformin for visceral fat reduction in patients with type 2 diabetes receiving treatment with dipeptidyl peptidase-4 inhibitors in Japan: a study protocol for a prospective, multicentre, blinded-endpoint phase IV randomised controlled trial (PRIME-V study)
  1. Masaya Koshizaka1,2,
  2. Ko Ishikawa1,2,
  3. Takahiro Ishikawa1,2,
  4. Kazuki Kobayashi1,2,
  5. Minoru Takemoto1,2,
  6. Takuro Horikoshi3,
  7. Ryota Shimofusa4,
  8. Sho Takahashi5,
  9. Kengo Nagashima6,
  10. Yasunori Sato6,
  11. Ichiro Tatsuno7,
  12. Takashi Terano8,
  13. Naotake Hashimoto9,
  14. Nobuichi Kuribayashi10,
  15. Daigaku Uchida11,
  16. Koutaro Yokote1,2
  17. on behalf of the PRIME-V Study Investigators
  1. 1 Department of Diabetes, Metabolism and Endocrinology, Chiba University, Chiba, Japan
  2. 2 Department of Clinical Cell Biology and Medicine, Chiba University Graduate School of Medicine, Chiba, Japan
  3. 3 Diagnostic Radiology and Radiation Oncology, Chiba University Graduate School of Medicine, Chiba, Japan
  4. 4 Department of Radiology, Sannou Hospital, Chiba, Japan
  5. 5 Clinical Research Center, Chiba University Hospital, Chiba, Japan
  6. 6 Department of Global Clinical Research, Chiba University Graduate School of Medicine, Chiba, Japan
  7. 7 Center of Diabetes, Endocrinology and Metabolism, Toho University Sakura Medical Center, Sakura, Japan
  8. 8 Department of Internal Medicine, Chiba Aoba Municipal Hospital, Chiba, Japan
  9. 9 Department of Diabetes/Metabolic Endocrinology, Tokyo Women’s Medical University Yachiyo Medical Center, Yachiyo, Japan
  10. 10 Misaki Naika Clinic, Funabashi, Japan
  11. 11 Hotaruno Central Naika, Kisarazu, Japan
  1. Correspondence to Professor Koutaro Yokote; kyokote{at}faculty.chiba-u.jp

Abstract

Introduction In Japan, dipeptidyl peptidase-4 (DPP-4) inhibitors are frequently used as the treatment of choice for patients with type 2 diabetes. In some cases, however, poor glycaemic and body weight control issues persist despite treatment with DPP-4 inhibitors. Previous researchers have revealed that sodium-dependent glucose transporter-2 (SGLT-2) inhibitors reduce both plasma glucose levels and body weight in patients with type 2 diabetes. However, further investigation regarding the effects of SGLT-2 inhibitors on body composition, especially in the Asian population who tends to have relatively low-to-moderate body mass indices, is required. Therefore, we aim to determine the effects of treatment with SGLT-2 inhibitors or metformin for reducing visceral fat in 106 Asian patients with type 2 diabetes who were undergoing treatment with the DPP-4 inhibitor sitagliptin (50 mg daily) for poor glycaemic control.

Methods and analysis A prospective, multicentre, blinded-endpoint phase IV randomised controlled study will be conducted to evaluate the safety and efficacy of a 24-week treatment with either an SGLT-2 inhibitor (ipragliflozin) or metformin for reducing visceral fat and plasma glucose levels in patients with type 2 diabetes. Patients who satisfy the eligibility criteria will be randomised (1:1) to receive ipragliflozin (50 mg daily) or metformin (1000 mg daily). The primary outcome is the rate of change in the total area of visceral fat for patients in both treatment groups, measured using CT, after 24 weeks of therapy. Two radiologists, blinded to the clinical information, will perform centralised analysis of the images in a unified measurement condition.

Ethics and dissemination The protocol was approved by the institutional review board of each hospital. This study is ongoing and due to finish in April 2017. The findings of this study will be disseminated via peer-reviewed publications and conference presentations, and will also be disseminated to participants.

Trial registration number UMIN000015170, R000016861 (https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000016861); Pre-results

  • sodium-dependent glucose transporter-2 inhibitor
  • metformin
  • visceral fat reduction
  • dipeptidyl peptidase-4 inhibitor
  • type 2 diabetes
  • glucose

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2016-015766

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    Footnotes

    • Contributors All authors made a significant contribution to the conception and design of the study protocol. KY designed the original concept. The protocol was written by MK, KI, TI, KK and MT, and it was critically reviewed by TH, RS, ST, KN, YS, IT, TT, NH, NK, DU, and KY. All authors provided approval for the publication of the manuscript.

    • Funding To conduct this study, an agreement was signed between Chiba University and Astellas Pharma (Tokyo, Japan). This work was funded by Astellas Pharma.

    • Competing interests KY received research grants from Astellas Pharma and MSD. KK received a lecture fee from Astellas Pharma and Sumitomo Dainippon Pharma (Tokyo, Japan). No conflicts of interest are declared for other authors.

    • Ethics approval The protocol was approved by the Institutional Review Board of each participating hospital.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Collaborators Collaborators of PRIME-V Study Investigators include Asahi General Hospital; Chiba Aoba Municipal Hospital; Chiba Chuo Geka Naika; Chiba Kaihin Municipal Hospital; Chiba Rosai Hospital; Chiba University Hospital; Funabashi Central Hospital; Funabashi Municipal Medical Center; Hotaruno Central Naika; Inage Hospital; Izumi Chuo Hospital; Kimitsu Chuo Hospital; National Hospital Organization Chiba Medical Center; Kujyukuri Home Hospital; Kouyukai Memorial Hospital; Seirei Sakura Citizen Hospital; Sousa Citizen Hospital; Tamura Memorial Hospital; Toho University Sakura Medical Center; Tokyo Womens Medical University Yachiyo Medical Center.