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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)
Author(s) -
Koshizaka Masaya,
Ishikawa Ko,
Ishibashi Ryoichi,
Maezawa Yoshiro,
Sakamoto Kenichi,
Uchida Daigaku,
Nakamura Susumu,
Yamaga Masaya,
Yokoh Hidetaka,
Kobayashi Akina,
Onishi Shunichiro,
Kobayashi Kazuki,
Ogino Jun,
Hashimoto Naotake,
Tokuyama Hirotake,
Shimada Fumio,
Ohara Emi,
Ishikawa Takahiro,
Shoji Mayumi,
Ide Shintaro,
Ide Kana,
Baba Yusuke,
Hattori Akiko,
Kitamoto Takumi,
Horikoshi Takuro,
Shimofusa Ryota,
Takahashi Sho,
Nagashima Kengo,
Sato Yasunori,
Takemoto Minoru,
Newby Laura Kristin,
Yokote Koutaro
Publication year - 2019
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.13750
Subject(s) - metformin , sitagliptin , medicine , type 2 diabetes , clinical endpoint , insulin resistance , endocrinology , body mass index , homeostatic model assessment , diabetes mellitus , glucose homeostasis , randomized controlled trial , gastroenterology , insulin
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.