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ACTIVE NOT RECRUITING
NCT04639414
PHASE4

Combined Active Treatment in Type 2 Diabetes with NASH

Sponsor: German Diabetes Center

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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.

DRUG

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