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Combined Active Treatment in Type 2 Diabetes with NASH
Sponsor: German Diabetes Center
Summary
The aim of this multicentre, prospective, placebo-controlled, double-blind, randomized, 3-arm parallel group, interventional study is to assess for the first time the effects of either a combined therapy with the antihyperglycemic drugs semaglutide and empagliflozin or empagliflozin monotherapy compared to placebo as potential treatments for non-alcoholic steatohepatitis (NASH) in patients with type 2 diabetes.
Key Details
Gender
All
Age Range
25 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
192
Start Date
2021-03-26
Completion Date
2025-12
Last Updated
2024-10-10
Healthy Volunteers
No
Conditions
Interventions
Empagliflozin 10mg oral tablet / Semaglutide 1mg pen injector
Measurement of the effect of the combined treatment with semaglutide 1mg/week and empagliflozin 10 mg/d compared to matching placebo after 48-week treatment.
Empagliflozin 10mg oral tablet and placebo pen injector matching semaglutide
Measurement of the effect of empagliflozin monotherapy 10mg/d compared to matching placebo after 48-week treatment.
Placebo matching empagliflozin and placebo pen injector matching semaglutide
Measurement of the effect of the combined treatment with semaglutide 1mg/week and empagliflozin 10 mg/d OR empagliflozin monotherapy 10mg/d compared to matching placebo after 48-week treatment.
Locations (26)
Medizinische Universität Graz
Graz, Austria
Medizinische Universität Innsbruck
Innsbruck, Austria
Wiener Gesundheitsverbund, Klinik Landstraße
Vienna, Austria
Medizinische Universität Wien
Vienna, Austria
Wiener Gesundheitsverbund, Klinik Hietzing
Vienna, Austria
German Diabetes Center
Düsseldorf, North Rhine-Westphalia, Germany
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany
Franziskus-Krankenhaus Berlin
Berlin, Germany
Leber- und Studienzentrum Checkpoint
Berlin, Germany
University Clinics Berlin Charité
Berlin, Germany
University Clinics Berlin Charité
Berlin, Germany
University Clinics Bochum
Bochum, Germany
Städtisches Klinikum Brandenburg GmbH
Brandenburg, Germany
Städtisches Klinikum Braunschweig gGmbH
Braunschweig, Germany
University Clinics Carl Gustav Carus Dresden
Dresden, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
University Clinics Essen
Essen, Germany
University Clinics Frankfurt
Frankfurt, Germany
University Clinics Freiburg
Freiburg im Breisgau, Germany
University Clinics Heidelberg
Heidelberg, Germany
Eugastro GmbH
Leipzig, Germany
University Clinics Johannes-Gutenberg Mainz
Mainz, Germany
TUM
München, Germany
University Clinics Tübingen
Tübingen, Germany
Universitätsklinikum Ulm
Ulm, Germany
University Clinics Würzburg
Würzburg, Germany