A Study Between Dapagliflozin and Empagliflozin Effect on NAFLD in Patients With Type 2 Diabetes.

NCT07363707 | Completed Phase 4 DMC

• 1 other identifier: effect of Dapa &Empa on NAFLD
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if drugs Dapagliflozin and Empagliflozin work to treat NAFLD in Type 2 diabetes patients. It will also learn about the safety of drugs dapagliflozin and empagliflozin. The main questions it aims to answer are: Do drug dapagliflozin and empagliflozin lower the NAFLD degree for participants? What medical problems do participants have when taking the drugs dapagliflozin and empagliflozin? Researchers will compare drug dapagliflozin to empagliflozin to see which of them more effective to treat NAFLD. Participants will: Take drug dapagliflozin or empaglifloin every day for 6 months Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler

Conditions

NAFLD (Nonalcoholic Fatty Liver Disease)

Keywords

Dapagliflozin and Empagliflozin

Outcome Measures

Primary Outcomes (1)

• Fibro scan, as well as the changes in FIB4 score and Full lipid profile (total cholesterol, LDL, HDL, VLDL, and triglyceride).

  by using Fibro scan(Controlled Attenuation Parameter (CAP) The liver CAP score assesses fatty change (S1, S2, S3 grades), and Elasticity Score (E) kilopascals (kPa)) as well as the changes in FIB4 score (has no units; it's a calculated index (a number) derived from blood tests (AST, ALT, platelets) and age) and Full lipid profile (total cholesterol, LDL, HDL, VLDL and triglyceride (mg/dL) ) from baseline to six months in the two groups. In a lipid profile, mg/dL stands for milligrams per deciliter. This is the standard unit of measurement used to express the concentration of cholesterol and fats in the blood. What it Measures The measurement indicates how many milligrams (mg) of a specific lipid are found in one deciliter (dL) of blood. A lipid profile typically reports several components using this unit: Total Cholesterol: The overall amount of cholesterol (mg) in your blood(dl). LDL (Low-Density Lipoprotein) HDL (High-Density Lipoprotein) VLDLvery Low-Density Lipopr Triglycerides

  at zero month and after 6 six months

Study Arms (2)

Dapagliflozin

ACTIVE COMPARATOR

Drug: Dapagliflozin + Metformin

Empagliflozin

ACTIVE COMPARATOR

Drug: Empa

Interventions

Dapagliflozin + Metformin DRUG

name and concentration of drug ( Dapagliflozin 10 mg)

Dapagliflozin

Empa DRUG

name and concentration of drug Empagliflozin 25

Empagliflozin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults from 18 years old, male or female type 2 diabetic NAFLD patients.

You may not qualify if:

• People who have chronic liver disease,
• Hepatitis C virus (HCV) patients or those treated for HCV,
• History of autoimmune disease,
• Drugs that cause steatohepatitis
• and alcoholic patients will be excluded.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni Suef University Hospital

Cairo, Egypt

Location

Related Publications (2)

• 11. Androutsakos T, Nasiri-Ansari N, Bakasis A-D, Kyrou I, Efstathopoulos E, Randeva HS, et al. SGLT-2 inhibitors in NAFLD: expanding their role beyond diabetes and cardioprotection. International journal of molecular sciences. 2022;23(6):3107. 12. Abdel-Rahman RF. Non-alcoholic fatty liver disease: epidemiology, pathophysiology and an update on the therapeutic approaches. Asian Pacific Journal of Tropical Biomedicine. 2022;12(3):99-114. 13. Athyros VG, Polyzos SA, Kountouras J, Katsiki N, Anagnostis P, Doumas M, et al. Non-Alcoholic Fatty Liver Disease Treatment in Patients with Type 2 Diabetes Mellitus; New Kids on the Block. Current vascular pharmacology. 2020;18(2):172-81. 14. Mohsen M, Elberry AA, Mohamed Rabea A, Abdelrahim ME, Hussein RR. Saxagliptin and vildagliptin lowered albuminuria in patients with diabetes and hypertension independent on glycaemic control. International Journal of Clinical Practice. 2021;75(3):e13769. 15. Xia C, Goud A, D'Souza J, Dahagam C, Rao X, Rajagopalan S, et al. DPP4 inhibitors and cardiovascular outcomes: safety on heart failure. Heart failure reviews. 2017;22:299-304. 16. Niezen S, Diaz del Castillo H, Mendez Castaner LA, Fornoni A. Safety and efficacy of antihyperglycaemic agents in diabetic kidney disease. Endocrinology, diabetes & metabolism. 2019;2(3):e00072. 17. Scheen A. Beneficial effects of SGLT2 inhibitors on fatty liver in type 2 diabetes: a common comorbidity associated with severe complications. Diabetes & metabolism. 2019;45(3):213-23. 18. Ciardullo S, Vergani M, Perseghin G. Nonalcoholic Fatty Liver Disease in Patients with Type 2 Diabetes: Screening, Diagnosis, and Treatment. Journal of Clinical Medicine. 2023;12(17):5597.

  BACKGROUND

• 1. Bica C, Sandu C, Suceveanu AI, Sarbu E, Stoica RA, Gherghiceanu F, et al. Non-alcoholic fatty liver disease: A major challenge in type 2 diabetes mellitus. Experimental and Therapeutic Medicine. 2020;20(3):2387-91. 2. Das C, Tripathy D, Swain S, Sudhakaran N, Uthansingh K, Mallick P, et al. Effect of Dapa on type 2 diabetes mellitus with nonalcoholic fatty liver disease: a single-center survey. Cureus. 2021;13(5). 3. Almahmoud MH, Al Khawaja NM, Alkinani A, Khader Y, Ajlouni KM. Prevalence of fatty liver disease and its associated factors among Jordanian patients with type 2 diabetes mellitus: A cross-sectional study. Annals of Medicine and Surgery. 2021;68:102677. 4. Tanase DM, Gosav EM, Costea CF, Ciocoiu M, Lacatusu CM, Maranduca MA, et al. The intricate relationship between type 2 diabetes mellitus (T2DM), insulin resistance (IR), and nonalcoholic fatty liver disease (NAFLD). Journal of diabetes research. 2020;2020(1):3920196. 5. Targher G, Corey KE, Byrne CD, Roden M. The complex link between NAFLD and type 2 diabetes mellitus-mechanisms and treatments. Nature reviews Gastroenterology & hepatology. 2021;18(9):599-612. 6. Stefan N, Cusi K. A global view of the interplay between non-alcoholic fatty liver disease and diabetes. The lancet Diabetes & endocrinology. 2022;10(4):284-96. 7. Younossi ZM. Non-alcoholic fatty liver disease-a global public health perspective. Journal of hepatology. 2019;70(3):531-44. 8. Loomba R, Abraham M, Unalp A, Wilson L, Lavine J, Doo E, et al. Association between diabetes, family history of diabetes, and risk of nonalcoholic steatohepatitis and fibrosis. Hepatology. 2012;56(3):943-51. 9. Musso G, Gambino R, Cassader M, Pagano G. Meta-analysis: natural history of non-alcoholic fatty liver disease (NAFLD) and diagnostic accuracy of non-invasive tests for liver disease severity. Annals of medicine. 2011;43(8):617-49. 10. Popoviciu MS, Păduraru L, Rahman MM, Supti FA, Stoica RA, Reurean-Pintilei D, et al. The effects of SGLT2 inhibitor

  BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

dapagliflozin; Metformin

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: bachelor of clinical pharmacy

Model Details: In this prospective randomized controlled trial, a number of 108 patients of MASLD and T2DM were enrolled into 2 equal groups to either receive Dapa 10mg /day(control group; n=54) or or Empa 25mg/day (n = 54), in addition to conventional therapy (metformin) for 6 months.

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 23, 2026
• Study Start: May 1, 2023
• Primary Completion: August 27, 2023
• Study Completion: March 1, 2024
• Last Updated: February 3, 2026

Record last verified: 2025-12

Locations

EG (1)