Novel Antidiabetic Medications and Their Effect on Liver Steatosis (NAMELS-18)

NCT05946148 | Completed FDA Drug

• 1 other identifier: SC12/16-6-2016
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical study is to compare the therapeutic effect of Dulaglutide and Empagliflozin in patients with Diabetes Mellitus type 2 and Non-Alcoholic Fatty Liver Disease. The main question it aims to answer is: Is there a beneficial effect regarding liver steatosis in patients receiving either of these 2 medications and which is more effective? Patients will undergo shearwave elastography, magnetic resonance imaging, and ultrasound. Furthermore, calculation of the Fatty Liver Index (FLI), the Fibrosis-4 Index (FIB-4), as well as the Aspartate Aminotransferase to Platelet ratio Index (APRI) and the NAFLD Fibrosis Score (NFS) will be performed. Researchers will compare 3 groups: Group 1 will receive oral Empagliflozin, as add-on to their previous treatment regimen, for 52 weeks. Group 2 will receive subcutaneous Dulaglutide, as add-on to their previous treatment regimen, for 52 weeks. Group 3 will receive other optimal antidiabetic treatment (apart from agents of the GLP1-ras or SGLT2-is families) for 52 weeks.

Conditions

Non-Alcoholic Fatty Liver Disease; Liver Steatosis

Keywords

Empagliflozin; Dulaglutide; Liver Steatosis

Outcome Measures

Primary Outcomes (2)

• Liver Fat Fraction reduction

  Change of Liver Fat Fraction as calculated by MRI-PDFF

  52 weeks

• >30% Liver Fat Fraction reduction

  Percentage of each group's participants that achieves \>30% Liver Fat Fraction reduction

  52 weeks

Secondary Outcomes (7)

• HbA1c change

  52 weeks

• Body Mass Index change

  52 weeks

• Fatty Liver Index (FLI)

  52 weeks

• Fibrosis-4 Index (FIB-4)

  52 weeks

• Aspartate Aminotransferase to Platelet ratio Index (APRI)

  52 weeks

Study Arms (3)

Empagliflozin group

Oral Empagliflozin 10mg daily, as add-on to their previous treatment regimen.

Drug: Empagliflozin

Dulaglutide group

Subcutaneous Dulaglutide 1.5mg weekly, as add-on to their previous treatment regimen.

Drug: Dulaglutide

Control group

Optimal anti-diabetic treatment (apart from agents of the GLP1-ras or SGLT2-is families), targeting glycemic control.

Drug: Control Rx

Interventions

Empagliflozin DRUG

Empagliflozin 10mg daily, as add-on to previous treatment regimen.

Also known as: E

Empagliflozin group

Dulaglutide DRUG

Dulaglutide 1.5mg weekly, as add-on to previous treatment regimen

Also known as: D

Dulaglutide group

Control Rx DRUG

Optimal anti-diabetic treatment excluding agents of the GLP1-ras or SGLT2-is families.

Also known as: C

Control group

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Caucasian, 25-75 years old, diagnosed with type 2 diabetes mellitus and fatty liver.

You may qualify if:

• Presence of diabetes mellitus type 2 and non-alcoholic fatty liver Stable anti-diabetic treatment regimen for the past 6 months

You may not qualify if:

• Recent (last 5 years) medical history of cancer, pancreatitis, viral hepatitis or any other cause of liver disease (alcohol abuse, autoimmune hepatitis, hemochromatosis, heart failure etc.) Recent alteration (\<6 months) of anti-diabetic regimen. Already established treatment with GLP1-ras or SGLT2-is prior to screening. Treatment with Pioglitazone. Corticotherapy administration. Pregnant or planning for pregnancy.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead
• Alexandra Hospital, Athens, Greece: collaborator
• Hippocration General Hospital: collaborator

Study Sites (1)

"Hippocration" General Hospital of Athens

Athens, Attica, 11527, Greece

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

2 vials of serum taken at each patient visit

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Interventions

empagliflozin; dulaglutide; Fumigant 93; Tin Fluorides

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Tin Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• JOHN KOSKINAS, PROFESSOR

  National and Kapodistrian University of Athens

  STUDY CHAIR

• ANASTASIA THANOPOULOU, AS PROFESSOR

  National and Kapodistrian University of Athens

  STUDY DIRECTOR

• MELANIE DEUTSCH, AS PROFESSOR

  National and Kapodistrian University of Athens

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: INTERNIST

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 14, 2023
• Study Start: June 1, 2018
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 1 year
• Access Criteria: Upon request

Locations

GR (1)