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

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

Timeline

Start

2023-05-01

Primary completion

2023-08-27

Completion

2024-03-01

Publications

• Background 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

Drugs

Indications