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)

Masaya Koshizaka, Ko Ishikawa, Takahiro Ishikawa, Kazuki Kobayashi, Minoru Takemoto, Takuro Horikoshi, Ryota Shimofusa, Sho Takahashi, Kengo Nagashima, Yasunori Sato, Ichiro Tatsuno, Takashi Terano, Naotake Hashimoto, Nobuichi Kuribayashi, Daigaku Uchida, Koutaro Yokote

Research output: Contribution to journalArticle

2 Citations (Scopus)

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.

Original languageEnglish
Article numbere015766
JournalBMJ open
Volume7
Issue number5
DOIs
Publication statusPublished - 2017 May 1
Externally publishedYes

Fingerprint

Dipeptidyl-Peptidase IV Inhibitors
Intra-Abdominal Fat
Metformin
Sodium-Glucose Transporter 2
Type 2 Diabetes Mellitus
Japan
Randomized Controlled Trials
Safety
Therapeutics
Body Weight
Glucose
Research Ethics Committees
ipragliflozin
Body Composition
Ethics
Publications
Body Mass Index
Research Personnel

Keywords

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

ASJC Scopus subject areas

  • Medicine(all)

Cite this

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). / Koshizaka, Masaya; Ishikawa, Ko; Ishikawa, Takahiro; Kobayashi, Kazuki; Takemoto, Minoru; Horikoshi, Takuro; Shimofusa, Ryota; Takahashi, Sho; Nagashima, Kengo; Sato, Yasunori; Tatsuno, Ichiro; Terano, Takashi; Hashimoto, Naotake; Kuribayashi, Nobuichi; Uchida, Daigaku; Yokote, Koutaro.

In: BMJ open, Vol. 7, No. 5, e015766, 01.05.2017.

Research output: Contribution to journalArticle

Koshizaka, M, Ishikawa, K, Ishikawa, T, Kobayashi, K, Takemoto, M, Horikoshi, T, Shimofusa, R, Takahashi, S, Nagashima, K, Sato, Y, Tatsuno, I, Terano, T, Hashimoto, N, Kuribayashi, N, Uchida, D & Yokote, K 2017, '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)', BMJ open, vol. 7, no. 5, e015766. https://doi.org/10.1136/bmjopen-2016-015766
Koshizaka, Masaya ; Ishikawa, Ko ; Ishikawa, Takahiro ; Kobayashi, Kazuki ; Takemoto, Minoru ; Horikoshi, Takuro ; Shimofusa, Ryota ; Takahashi, Sho ; Nagashima, Kengo ; Sato, Yasunori ; Tatsuno, Ichiro ; Terano, Takashi ; Hashimoto, Naotake ; Kuribayashi, Nobuichi ; Uchida, Daigaku ; Yokote, Koutaro. / 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). In: BMJ open. 2017 ; Vol. 7, No. 5.
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AU - Koshizaka, Masaya

AU - Ishikawa, Ko

AU - Ishikawa, Takahiro

AU - Kobayashi, Kazuki

AU - Takemoto, Minoru

AU - Horikoshi, Takuro

AU - Shimofusa, Ryota

AU - Takahashi, Sho

AU - Nagashima, Kengo

AU - Sato, Yasunori

AU - Tatsuno, Ichiro

AU - Terano, Takashi

AU - Hashimoto, Naotake

AU - Kuribayashi, Nobuichi

AU - Uchida, Daigaku

AU - Yokote, Koutaro

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N2 - 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.

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