Combined Active Treatment in Type 2 Diabetes With NASH (COMBATT2NASH)
Type 2 Diabetes, Non-alcoholic Steatohepatitis (NASH), Non-alcoholic Fatty Liver Disease (NAFLD)
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, Non-alcoholic Steatohepatitis (NASH), Non-alcoholic Fatty Liver Disease (NAFLD), Fatty liver, Diabetes mellitus, Empagliflozin, Semaglutide
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of T2D and NASH with fibrosis stage F1-F3
- Age between 25 and 75 years
- HbA1c ≤ 9.5%
- obtained written informed consent
Exclusion Criteria:
- Contraindications on liver biopsy
- Evidence of cirrhosis on liver biopsy
- Liver disease of other etiology including chronic viral hepatitis (B or C), alcohol abuse, hemochromatosis, alpha-1 antitrypsin deficiency, autoimmune hepatitis, Wilson's disease, primary sclerosing cholangitis or primary biliary cirrhosis, or liver cirrhosis of any etiology
- History of ketoacidosis
- Alcohol consumption >30 g/d for males and >20 g/d for females
- Past (≥5 years) or current history of alcohol or drug abuse and/or psychiatric disease including severe depression necessitating pharmacological treatment
- Medications that may induce steatosis:tamoxifen, raloxifene, oral glucocorticoids or chloroquine
- Planned pregnancy, pregnant or lactating women, positive pregnancy test, and woman of childbearing potential not using two adequate methods of contraception, including a barrier method and a highly efficacious non-barrier method
Sites / Locations
- German Diabetes CenterRecruiting
- Herz- und Diabeteszentrum NRWRecruiting
- Franziskus-Krankenhaus BerlinRecruiting
- Leber- und Studienzentrum Checkpoint
- University Clinics Berlin Charité
- University Clinics Berlin Charité
- University Clinics BochumRecruiting
- Städtisches Klinikum Brandenburg GmbH
- Städtisches Klinikum Braunschweig gGmbHRecruiting
- University Clinics Carl Gustav Carus DresdenRecruiting
- Universitätsklinikum Düsseldorf
- University Clinics EssenRecruiting
- St.Josef-Krankenhaus KupferdrehRecruiting
- University Clinics FrankfurtRecruiting
- University Clinics FreiburgRecruiting
- Diabetes-Zentrum GelnhausenRecruiting
- University Clinics HeidelbergRecruiting
- Eugastro GmbHRecruiting
- University Clinics Johannes-Gutenberg MainzRecruiting
- University Clinics Munich LMU
- TUM
- University Clinics Münster
- Schwerpunktpraxis für Diabetes und Ernährungsmedizin
- University Clinics TübingenRecruiting
- University Clinics WürzburgRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Combined treatment with Empagliflozin and Semaglutide
Empagliflozin monotherapy
Placebo
Combined treatment with Empagliflozin, film-coated tablet, 10mg once daily and Semaglutide, colourless solution in pre-filled pen, 1mg once weekly
Empagliflozin, film-coated tablet, 10mg once daily and Placebo matching Semaglutide (colourless solution in pre-filled pen, once weekly)
Placebo matching Empagliflozin (film-coated tablet, once daily) and Placebo matching Semaglutide (colourless solution in pre-filled pen, once weekly)