PT - JOURNAL ARTICLE AU - Masato Yoneda AU - Yasushi Honda AU - Yuji Ogawa AU - Takaomi Kessoku AU - Takashi Kobayashi AU - Kento Imajo AU - Anna Ozaki AU - Asako Nogami AU - Masataka Taguri AU - Takeharu Yamanaka AU - Hiroyuki Kirikoshi AU - Tomoyuki Iwasaki AU - Takeo Kurihashi AU - Satoru Saito AU - Atsushi Nakajima TI - Comparing the effects of tofogliflozin and pioglitazone in non-alcoholic fatty liver disease patients with type 2 diabetes mellitus (ToPiND study): a randomized prospective open-label controlled trial AID - 10.1136/bmjdrc-2020-001990 DP - 2021 Feb 01 TA - BMJ Open Diabetes Research & Care PG - e001990 VI - 9 IP - 1 4099 - http://drc.bmj.com/content/9/1/e001990.short 4100 - http://drc.bmj.com/content/9/1/e001990.full SO - BMJ Open Diab Res Care2021 Feb 01; 9 AB - Introduction The treatment of diabetes has a significant impact on the pathogenesis of non-alcoholic fatty liver disease (NAFLD). We compared the effectiveness of tofogliflozin, a selective sodium-glucose cotransporter 2 inhibitor, and pioglitazone for the treatment of NAFLD patients with type 2 diabetes mellitus.Research design and methods This open-label, prospective, single-center, randomized clinical trial recruited NAFLD patients with type 2 diabetes mellitus and a hepatic fat fraction of at least 10% as assessed based on the MRI-proton density fat fraction (MRI-PDFF). Eligible patients were stratified according to hemoglobin A1c (HbA1c), alanine transaminase, and MRI-PDFF levels and randomly assigned (1:1) to receive either 20 mg tofogliflozin or 15–30 mg pioglitazone, orally, once daily for 24 weeks. The primary endpoint was an absolute change in MRI-PDFF at 24 weeks. Efficacy and safety was assessed in all treated patients. This trial was registered in the Japan Registry of Clinical Trials.Results Overall, 40 eligible patients were randomly assigned to receive tofogliflozin (n=21) or pioglitazone (n=19). Changes in hepatic steatosis after 24 weeks of treatment were evaluated by MRI-PDFF, which showed a significant decrease in both groups (−7.54% (p<0.0001) and −4.12% (p=0.0042) in the pioglitazone and tofogliflozin groups, respectively). Compared with baseline, the body weight decreased by 2.83±2.86 kg (−3.6%, p=0.0443) in the tofogliflozin group and increased by 1.39±2.62 kg (1.7%, p=0.0002) in the pioglitazone group after 24 weeks. No life-threatening events or treatment-related deaths occurred.Conclusions Tofogliflozin was well tolerated, and it reduced the MRI-PDFF levels in NAFLD patients with type 2 diabetes mellitus.Trial registration number jRCTs031180159.