Clinical Trial Details
| Trial ID: | L0162 |
| Source ID: | NCT04639414 |
| Associated Drug: | Empagliflozin |
| Title: | Combined Active Treatment in Type 2 Diabetes With NASH |
| Acronym: | COMBATT2NASH |
| Status: | Recruiting |
| Study Results: | No Results Available |
| Results: | -- |
| Conditions: | Type 2 Diabetes|Non-alcoholic Steatohepatitis (NASH)|Non-alcoholic Fatty Liver Disease (NAFLD) |
| Interventions: | Drug: Empagliflozin 10mg oral tablet / Semaglutide 1mg pen injector|Drug: Empagliflozin 10mg oral tablet and placebo pen injector matching semaglutide|Drug: Placebo matching empagliflozin and placebo pen injector matching semaglutide |
| Outcome Measures: | Histological resolution of NASH without worsening of fibrosis|Overall NAFLD activity score (NAS)|Stage of fibrosis according to the Kleiner Fibrosis Classification|Activity component of NASH according to the steatosis-activity-fibrosis (SAF) score|Hepatic steatosis grade |
| Sponsor/Collaborators: | The Deutsche Diabetes Forschungsgesellschaft e.V.|Boehringer Ingelheim|German Center for Diabetes Research|Federal Ministry of Health, Germany|Ministry of Innovation, Science and Research in North Rhine-Westphalia|Novo Nordisk A/S|German Diabetes Center |
| Gender: | All |
| Age: | 25 Years to 75 Years ?? (Adult, Older Adult) |
| Phases: | Phase 4 |
| Enrollment: | 192 |
| Study Type: | Interventional |
| Study Designs: | Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment |
| Start Date: | March 26, 2021 |
| Completion Date: | December 2023 |
| Results First Posted: | -- |
| Last Update Posted: | January 20, 2022 |
| Locations: | German Diabetes Center, Duesseldorf, Nordrhein-Westfalen, Germany|Herz- und Diabeteszentrum NRW, Bad Oeynhausen, Germany|Franziskus-Krankenhaus Berlin, Berlin, Germany|Leber- und Studienzentrum Checkpoint, Berlin, Germany|University Clinics Berlin Charit??, Berlin, Germany|University Clinics Berlin Charit??, Berlin, Germany|University Clinics Bochum, Bochum, Germany|St??dtisches Klinikum Brandenburg GmbH, Brandenburg, Germany|St??dtisches Klinikum Braunschweig gGmbH, Braunschweig, Germany|University Clinics Carl Gustav Carus Dresden, Dresden, Germany|Universit??tsklinikum D??sseldorf, D??sseldorf, Germany|University Clinics Essen, Essen, Germany|St.Josef-Krankenhaus Kupferdreh, Essen, Germany|University Clinics Frankfurt, Frankfurt, Germany|University Clinics Freiburg, Freiburg, Germany|Diabetes-Zentrum Gelnhausen, Gelnhausen, Germany|University Clinics Greifswald, Greifswald, Germany|Medizinische Hochschule Hannover, Hannover, Germany|University Clinics Heidelberg, Heidelberg, Germany|Mesut Durmaz, Hof, Germany|Eugastro GmbH, Leipzig, Germany|University Clinics Leipzig, Leipzig, Germany|University Clinics Johannes-Gutenberg Mainz, Mainz, Germany|University Clinics Munich LMU, Munich, Germany|TUM, M??nchen, Germany|University Clinics M??nster, M??nster, Germany|Schwerpunktpraxis f??r Diabetes und Ern??hrungsmedizin, M??nster, Germany|University Clinics T??bingen, T??bingen, Germany|University Clinics Ulm, Ulm, Germany|University Clinics W??rzburg, W??rzburg, Germany |
| URL: | https://ClinicalTrials.gov/show/NCT04639414 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D122 | Empagliflozin | Chemical drug | DB09038 | SLC5A2 inhibitor; SGLT-2 inhibitor | Improve insulin resistance | Under clinical trials | Details |
| D083 | CLA | Chemical drug | DB01211 | KCNH2; SLCO1B1; SLCO1B3 | -- | Under clinical trials | Details |
| D327 | Semaglutide | Chemical drug | DB13928 | GLP1R agonist | Antidiabetic drug | Under clinical trials | Details |