non-alcoholic steatohepatitis type 2 diabetes
Conditions
Interventions
Intervention group After obtaining a written consent and completing baseline examination, semaglutide (0.25 mg) will be injected subcutaneously once a week. After 2 weeks of semaglutide treatment,
Sponsors
Ehime University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 20 to 75 years at the time of consent 2. Patients with type 2 diabetes who were diagnosed with NASH with stage 1 or more and NAS 4 or more according to the classification of the NASH Clinical Research Network (NASH CRN) by liver biopsy within 6 months (180 days) before pre-examination or consent acquisition 3. Patients with HbA1c 6.5% or more (HbA1c 6% or more for those undergoing drug treatment) and 10.5% or less in the preliminary examination 4. Patients who provided written consent to participate in this study
Exclusion criteria
Exclusion criteria: 1. Patients who received SGLT2 inhibitors or GLP-1 receptor agonists within 3 months prior to the start of the drug administration study or after liver biopsy 2. Patients who used other SGLT2 inhibitors or GLP-1 receptor agonists during the study period 3. Patients with a history of serious adverse reactions to SGLT2 inhibitors or GLP-1 receptor agonists 4. Patients with uncompensated liver cirrhosis 5. Patients with serious renal disease 6. Patients with malignant tumor 7. Patients with a history of severe hypoglycemia 8. Patients with a history of ketoacidosis 9. Patients with a history of cerebral infarction with paralysis 10. Patients with urinary tract/genital infections or repeated urinary tract/genital infections 11. Patients with hepatitis due to other causes 12. Patients who were hospitalized for acute coronary syndrome, unstable angina, acute myocardial infarction, acute cerebral infarction, or transient ischemic attack within 3 months prior to obtaining consent 13. Pregnant or lactating women 14. Patients who had started or changed the dose of pioglitazone or vitamin E within 6 months prior to starting the study drug, or within 3 months prior to liver biopsy until starting the study drug 15. Patients who regularly use oral steroids or injectable steroids 16. Patients who are participating in other clinical studies using the study drug while participating in this study 17. If, in the opinion of the Principal Investigator, or others, participation in the research is not in the best interest of the research subject, or if it is judged to interfere with, limit, or confuse the specific evaluation of the clinical research protocol 18. A person under the direction of the Principal Investigator or the medical institution conducting the research, an employee of the Principal Investigator or of the medical institution directly involved in this or other clinical research, or family members of such employees or the Principal Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Resolution of NASH without worsening of liver fibrosis after 52 weeks 2. Improvement of at least one point in NAFLD activity score without worsening of liver fibrosis after 52 weeks 3. Improvement of at least one fibrosis stage without worsening of NASH after 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of cases with progression of liver fibrosis after 52 weeks 2. Change from baseline in liver stiffness according to FibroScan after 52 weeks 3. Change from baseline in steatosis according to FibroScan after 52 weeks 4. Change from baseline in weight, BMI, and body composition after 52 weeks 5. Change from baseline in HbA1c after 52 weeks 6. Change from baseline in liver enzymes after 52 weeks | — |
Countries
Japan
Contacts
Public ContactTeruki Miyake
Ehime University Hospital Internal Medicine 3
Outcome results
None listed