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).

Published

Journal Article

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/m2 . 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.

Full Text

Duke Authors

Cited Authors

  • Koshizaka, M; Ishikawa, K; Ishibashi, R; Maezawa, Y; Sakamoto, K; Uchida, D; Nakamura, S; Yamaga, M; Yokoh, H; Kobayashi, A; Onishi, S; Kobayashi, K; Ogino, J; Hashimoto, N; Tokuyama, H; Shimada, F; Ohara, E; Ishikawa, T; Shoji, M; Ide, S; Ide, K; Baba, Y; Hattori, A; Kitamoto, T; Horikoshi, T; Shimofusa, R; Takahashi, S; Nagashima, K; Sato, Y; Takemoto, M; Newby, LK; Yokote, K; PRIME-V Study Group,

Published Date

  • August 2019

Published In

Volume / Issue

  • 21 / 8

Start / End Page

  • 1990 - 1995

PubMed ID

  • 30993861

Pubmed Central ID

  • 30993861

Electronic International Standard Serial Number (EISSN)

  • 1463-1326

Digital Object Identifier (DOI)

  • 10.1111/dom.13750

Language

  • eng

Conference Location

  • England