Comparing the effects of ipragliflozin versus metformin on visceral fat reduction and metabolic dysfunction in Japanese patients with type 2 diabetes treated with sitagliptin: A prospective, multicentre, open-label, blinded-endpoint, randomized controlled study (PRIME-V study)

On Behalf of the PRIME-V Study Group

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

A prospective, multicentre, open-label, blinded-endpoint, randomized controlled study was conducted to evaluate the efficacy of treatment with ipragliflozin (sodium-dependent glucose transporter-2 inhibitor) versus metformin for visceral fat reduction and glycaemic control among Japanese patients with type 2 diabetes treated with sitagliptin, HbA1c levels of 7%-10%, and body mass index (BMI) ≥ 22 kg/m 2 . Patients were randomly assigned (1:1) to receive ipragliflozin 50 mg or metformin 1000-1500 mg daily. The primary outcome was change in visceral fat area as measured by computed tomography after 24 weeks of therapy. The secondary outcomes were effects on glucose metabolism and lipid metabolism. Mean percentage reduction in visceral fat area was significantly greater in the ipragliflozin group than in the metformin group (−12.06% vs. −3.65%, P = 0.040). Ipragliflozin also significantly reduced BMI, subcutaneous fat area, waist circumference, fasting insulin, and homeostatic model assessment (HOMA)-resistance, and increased HDL-cholesterol levels. Metformin significantly reduced HbA1c and LDL-cholesterol levels and increased HOMA-beta. There were no severe adverse events. The use of ipragliflozin or metformin in combination with dipeptidyl peptidase-4 inhibitors, widely used in Japan, may have beneficial effects in ameliorating multiple cardiovascular risk factors.

Original languageEnglish
JournalDiabetes, Obesity and Metabolism
DOIs
Publication statusPublished - 2019 Jan 1
Externally publishedYes

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Intra-Abdominal Fat
Metformin
Type 2 Diabetes Mellitus
Sodium-Glucose Transporter 2
Body Mass Index
Dipeptidyl-Peptidase IV Inhibitors
Subcutaneous Fat
Waist Circumference
Lipid Metabolism
LDL Cholesterol
HDL Cholesterol
Fasting
Japan
Tomography
Sitagliptin Phosphate
ipragliflozin
Insulin
Glucose

Keywords

  • insulin sensitivity
  • ipragliflozin
  • metformin
  • sitagliptin
  • visceral fat

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

@article{7db268bdfdd24e7e8ca3554dc8372843,
title = "Comparing the effects of ipragliflozin versus metformin on visceral fat reduction and metabolic dysfunction in Japanese patients with type 2 diabetes treated with sitagliptin: A prospective, multicentre, open-label, blinded-endpoint, randomized controlled study (PRIME-V study)",
abstract = "A prospective, multicentre, open-label, blinded-endpoint, randomized controlled study was conducted to evaluate the efficacy of treatment with ipragliflozin (sodium-dependent glucose transporter-2 inhibitor) versus metformin for visceral fat reduction and glycaemic control among Japanese patients with type 2 diabetes treated with sitagliptin, HbA1c levels of 7{\%}-10{\%}, and body mass index (BMI) ≥ 22 kg/m 2 . Patients were randomly assigned (1:1) to receive ipragliflozin 50 mg or metformin 1000-1500 mg daily. The primary outcome was change in visceral fat area as measured by computed tomography after 24 weeks of therapy. The secondary outcomes were effects on glucose metabolism and lipid metabolism. Mean percentage reduction in visceral fat area was significantly greater in the ipragliflozin group than in the metformin group (−12.06{\%} vs. −3.65{\%}, P = 0.040). Ipragliflozin also significantly reduced BMI, subcutaneous fat area, waist circumference, fasting insulin, and homeostatic model assessment (HOMA)-resistance, and increased HDL-cholesterol levels. Metformin significantly reduced HbA1c and LDL-cholesterol levels and increased HOMA-beta. There were no severe adverse events. The use of ipragliflozin or metformin in combination with dipeptidyl peptidase-4 inhibitors, widely used in Japan, may have beneficial effects in ameliorating multiple cardiovascular risk factors.",
keywords = "insulin sensitivity, ipragliflozin, metformin, sitagliptin, visceral fat",
author = "{On Behalf of the PRIME-V Study Group} and Masaya Koshizaka and Ko Ishikawa and Ryoichi Ishibashi and Yoshiro Maezawa and Kenichi Sakamoto and Daigaku Uchida and Susumu Nakamura and Masaya Yamaga and Hidetaka Yokoh and Akina Kobayashi and Shunichiro Onishi and Kazuki Kobayashi and Jun Ogino and Naotake Hashimoto and Hirotake Tokuyama and Fumio Shimada and Emi Ohara and Takahiro Ishikawa and Mayumi Shoji and Shintaro Ide and Kana Ide and Yusuke Baba and Akiko Hattori and Takumi Kitamoto and Takuro Horikoshi and Ryota Shimofusa and Sho Takahashi and Kengo Nagashima and Yasunori Sato and Minoru Takemoto and Newby, {Laura Kristin} and Koutaro Yokote",
year = "2019",
month = "1",
day = "1",
doi = "10.1111/dom.13750",
language = "English",
journal = "Diabetes, Obesity and Metabolism",
issn = "1462-8902",
publisher = "Wiley-Blackwell",

}

TY - JOUR

T1 - Comparing the effects of ipragliflozin versus metformin on visceral fat reduction and metabolic dysfunction in Japanese patients with type 2 diabetes treated with sitagliptin

T2 - A prospective, multicentre, open-label, blinded-endpoint, randomized controlled study (PRIME-V study)

AU - On Behalf of the PRIME-V Study Group

AU - Koshizaka, Masaya

AU - Ishikawa, Ko

AU - Ishibashi, Ryoichi

AU - Maezawa, Yoshiro

AU - Sakamoto, Kenichi

AU - Uchida, Daigaku

AU - Nakamura, Susumu

AU - Yamaga, Masaya

AU - Yokoh, Hidetaka

AU - Kobayashi, Akina

AU - Onishi, Shunichiro

AU - Kobayashi, Kazuki

AU - Ogino, Jun

AU - Hashimoto, Naotake

AU - Tokuyama, Hirotake

AU - Shimada, Fumio

AU - Ohara, Emi

AU - Ishikawa, Takahiro

AU - Shoji, Mayumi

AU - Ide, Shintaro

AU - Ide, Kana

AU - Baba, Yusuke

AU - Hattori, Akiko

AU - Kitamoto, Takumi

AU - Horikoshi, Takuro

AU - Shimofusa, Ryota

AU - Takahashi, Sho

AU - Nagashima, Kengo

AU - Sato, Yasunori

AU - Takemoto, Minoru

AU - Newby, Laura Kristin

AU - Yokote, Koutaro

PY - 2019/1/1

Y1 - 2019/1/1

N2 - A prospective, multicentre, open-label, blinded-endpoint, randomized controlled study was conducted to evaluate the efficacy of treatment with ipragliflozin (sodium-dependent glucose transporter-2 inhibitor) versus metformin for visceral fat reduction and glycaemic control among Japanese patients with type 2 diabetes treated with sitagliptin, HbA1c levels of 7%-10%, and body mass index (BMI) ≥ 22 kg/m 2 . Patients were randomly assigned (1:1) to receive ipragliflozin 50 mg or metformin 1000-1500 mg daily. The primary outcome was change in visceral fat area as measured by computed tomography after 24 weeks of therapy. The secondary outcomes were effects on glucose metabolism and lipid metabolism. Mean percentage reduction in visceral fat area was significantly greater in the ipragliflozin group than in the metformin group (−12.06% vs. −3.65%, P = 0.040). Ipragliflozin also significantly reduced BMI, subcutaneous fat area, waist circumference, fasting insulin, and homeostatic model assessment (HOMA)-resistance, and increased HDL-cholesterol levels. Metformin significantly reduced HbA1c and LDL-cholesterol levels and increased HOMA-beta. There were no severe adverse events. The use of ipragliflozin or metformin in combination with dipeptidyl peptidase-4 inhibitors, widely used in Japan, may have beneficial effects in ameliorating multiple cardiovascular risk factors.

AB - A prospective, multicentre, open-label, blinded-endpoint, randomized controlled study was conducted to evaluate the efficacy of treatment with ipragliflozin (sodium-dependent glucose transporter-2 inhibitor) versus metformin for visceral fat reduction and glycaemic control among Japanese patients with type 2 diabetes treated with sitagliptin, HbA1c levels of 7%-10%, and body mass index (BMI) ≥ 22 kg/m 2 . Patients were randomly assigned (1:1) to receive ipragliflozin 50 mg or metformin 1000-1500 mg daily. The primary outcome was change in visceral fat area as measured by computed tomography after 24 weeks of therapy. The secondary outcomes were effects on glucose metabolism and lipid metabolism. Mean percentage reduction in visceral fat area was significantly greater in the ipragliflozin group than in the metformin group (−12.06% vs. −3.65%, P = 0.040). Ipragliflozin also significantly reduced BMI, subcutaneous fat area, waist circumference, fasting insulin, and homeostatic model assessment (HOMA)-resistance, and increased HDL-cholesterol levels. Metformin significantly reduced HbA1c and LDL-cholesterol levels and increased HOMA-beta. There were no severe adverse events. The use of ipragliflozin or metformin in combination with dipeptidyl peptidase-4 inhibitors, widely used in Japan, may have beneficial effects in ameliorating multiple cardiovascular risk factors.

KW - insulin sensitivity

KW - ipragliflozin

KW - metformin

KW - sitagliptin

KW - visceral fat

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U2 - 10.1111/dom.13750

DO - 10.1111/dom.13750

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SN - 1462-8902

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