PMID- 33594581
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20211106
IS  - 1869-6953 (Print)
IS  - 1869-6961 (Electronic)
IS  - 1869-6961 (Linking)
VI  - 12
IP  - 3
DP  - 2021 Mar
TI  - Efficacy and Safety of Luseogliflozin in Patients with Type 2 Diabetes 
      Complicated by Hepatic Dysfunction: A Single-Site, Single-Arm, Open-Label, 
      Exploratory Trial.
PG  - 863-877
LID - 10.1007/s13300-021-01014-0 [doi]
AB  - INTRODUCTION: Improvements in glycemic control and hepatic function are 
      clinically important goals in the treatment of patients with type 2 diabetes 
      mellitus (T2DM) complicated by hepatic dysfunction. The favorable effects of the 
      sodium-glucose co-transporter inhibitor luseogliflozin on hepatic dysfunction 
      were anticipated for humans. Nevertheless, few clinical studies have confirmed 
      its real-world efficacy on hepatic dysfunction. This trial assessed the efficacy 
      and safety of luseogliflozin in patients with T2DM complicated by hepatic 
      dysfunction. METHODS: This prospective, single-site, single-arm, open-label, 
      exploratory trial included 55 subjects with T2DM complicated by hepatic 
      dysfunction. Subjects were administered luseogliflozin and observed for 52 weeks. 
      The primary endpoints were the change in aspartate aminotransferase (AST), 
      alanine aminotransferase (ALT), gamma-glutamyl transpeptidase (gamma-GTP), and 
      hemoglobin A1c (HbA1c) from baseline to week 52. The secondary endpoints included 
      body weight, body mass index (BMI), waist circumference, blood pressure, fasting 
      plasma glucose (FPG), homeostatic model assessment beta (HOMA-beta), homeostatic 
      model assessment of insulin resistance (HOMA-IR), ferritin, Mac-2 binding protein 
      (M2-BP), fatty liver index (FLI), fibrosis-4 (FIB-4) index, type IV collagen 7S 
      domain, nonalcoholic fatty liver disease (NAFLD) fibrosis score, high-sensitivity 
      C-reactive protein (hs-CRP), and interleukin-6 (IL-6). RESULTS: AST, ALT, gamma-GTP, 
      and HbA1c significantly decreased from baseline to week 52. Body weight, BMI, 
      waist circumference, and FPG also significantly decreased. HOMA-IR significantly 
      decreased but HOMA-beta was unchanged. FLI, ferritin, M2-BP, and NAFLD fibrosis 
      scores significantly decreased whereas the FIB-4 index and type IV collagen 7S 
      domain did not significantly change. The hs-CRP and IL-6 levels did not 
      significantly change. CONCLUSION: Luseogliflozin administration in patients with 
      T2DM complicated by hepatic dysfunction was well tolerated, did not worsen the 
      hepatic condition, and might even be beneficial to improve hepatic function, 
      reduce liver fat, and attenuate liver injury and fibrosis. TRIAL REGISTRATION: 
      This study was registered under the University Hospital Medical Information 
      Network Clinical Trial Registry (UMIN-CTR) (No. UMIN000025808) and the Japan 
      Registry of Clinical Trials (jRCT) (No. jRCTs021180017).
FAU - Seino, Hiroaki
AU  - Seino H
AUID- ORCID: 0000-0003-4690-9722
AD  - Seino Internal Medical Clinic, Kaisei, Koriyama, Fukushima, Japan. 
      kn7jh5@bma.biglobe.ne.jp.
LA  - eng
PT  - Journal Article
DEP - 20210216
PL  - United States
TA  - Diabetes Ther
JT  - Diabetes therapy : research, treatment and education of diabetes and related 
      disorders
JID - 101539025
EIN - Diabetes Ther. 2021 Oct;12(10):2807-2811. PMID: 34515989
PMC - PMC7947107
OTO - NOTNLM
OT  - Hepatic dysfunction
OT  - Luseogliflozin
OT  - SGLT2 inhibitor
OT  - Type 2 diabetes mellitus
EDAT- 2021/02/18 06:00
MHDA- 2021/02/18 06:01
PMCR- 2021/02/16
CRDT- 2021/02/17 05:59
PHST- 2020/12/23 00:00 [received]
PHST- 2021/01/27 00:00 [accepted]
PHST- 2021/02/18 06:00 [pubmed]
PHST- 2021/02/18 06:01 [medline]
PHST- 2021/02/17 05:59 [entrez]
PHST- 2021/02/16 00:00 [pmc-release]
AID - 10.1007/s13300-021-01014-0 [pii]
AID - 1014 [pii]
AID - 10.1007/s13300-021-01014-0 [doi]
PST - ppublish
SO  - Diabetes Ther. 2021 Mar;12(3):863-877. doi: 10.1007/s13300-021-01014-0. Epub 2021 
      Feb 16.