Type 2 diabetes mellitus with NAFLD/NASH NAFLD,NASH,NAFLD/NASH,Type 2 diabetes mellitus,liver fibrosis,fatty liver
Conditions
Interventions
Group A: Luseogliflozin hydrate 2.5 mg are orally administered once a day before breakfast or after breakfast for 72 weeks. If blood glucose control is insufficient, the dose can be increased to 5 mg
Sponsors
Kobayashi Takashi
Sumida Yoshio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) male and female, aged 20-80 years. (Regardless of hospitalization or outpatient) 2) Diagnosed as type 2 diabetes mellitus, with HbA1c>=6.5% or prescribed diabetes medication during the screening period 3) Patients who diagnosed with fatty liver by abdominal ultrasonography 4) MRI-PDFF>=5.0 % steatosis, and MRE>=2.5 kPa 5) Alcohol consumption less than 30 g/day ethanol for males or 20 g/day ethanol for females 6) Patients who provide written consent to participate in the trial of their own free will.
Exclusion criteria
Exclusion criteria: 1) Patients who diagnosed with type 1 diabetes or anti-GAD antibody positive 2) Patients with the following contraindications listed in the package insert of Luseogliflozin hydrate or Sitagliptin phosphate hydrate, and patients with a history of hypersensitivity to the ingredients of these drugs -Patients with severe ketosis, diabetic coma or precoma, type 1 diabetes -Patients with severe infections, before and after surgery, and severe external wounds 3) Patients with other liver diseases such as hepatitis C, hepatitis B (excluding inactive carriers), autoimmune hepatitis,primary biliary cholangitis, or with a history of hepatitis C (exclude cases 36 months or more after confirming virus negative) 4) BMI=11.0 % 10) Patients diagnosed hepatic cirrhosis or MRE>=6.7 kPa 11) Patients with portal hyper tension (platelet 2 x upper limit of JCCLS common reference value 13) Patients using SGLT2 inhibitors, DPP-4 inhibitors GLP-1 agonists, pioglitazon and insulin for 1 month before registration 14) Patients with mental illness, alcoholism or drug addiction that may affect adherence to the research plan 15) Patients who are ineligible in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in MRE value from baseline at 72 weeks post-administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in hepatic fibrosis from baseline at Week 24 (assessed by MRE) 2) Change in hepatic steatosis from baseline at Week 24 (assessed by MRI-PDFF) 3)Change in hepatic steatosis from baseline at Week 72 (assessed by MRI-PDFF) 4) Hepatobiliary disease-related events at Week 72: occurrence of cirrhosis, occurrence of hepatocellular carcinoma 5)Presence of cardiovascular events and other organ carcinogenesis at Week 72 6) Changes in clinical laboratory parameters from baseline at Weeks 12, 24, 48, and 72 7) Changes in vital signs, body weight, BMI, and waist circumference from baseline at Weeks 12, 24, 48, and 72 Frequency of adverse events and diseases | — |
Contacts
Public ContactTakashi Kobayashi
Yokohama City University Hospital
Outcome results
None listed