A clinical study to compare the efficacy & safety of two drugs- Empagliflozin and Pioglitazone in Non alcoholic fatty liver disease patients with diabetes.

Comparative study of efficacy and safety of Empagliflozin and Pioglitazone in Non-alcoholic fatty liver disease with Diabetes Mellitus. - NIL

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055756

Enrollment

120

Registered

2023-07-27

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Intervention1: Empagliflozin: 10mg OD for 6 months Control Intervention1: Pioglitazone: 15mg OD for 6 months

Eligibility

Inclusion criteria

Inclusion criteria: Patient having age group 25 to 75 years with documented diagnosis of Diabetes (HbA1C > 6.5%) with NAFLD (findings suggested hepatic steatosis & hepatic dysfunction on clinical laboratory tests or on imaging studies (e.g., Computed Tomography (CT) or ultrasound) or Calculated fibrosis score by Fib-4 Score > 1.3, NAFLD-LFS score > 0.064 & APRI Score range 0.4 - 1.5).

Exclusion criteria

Exclusion criteria: 1.Patient not willing to give consent form. 2.Patient with alcohol consumption. 3.Lactating & pregnant women. 4.Patient who already using drug such as SGLT-2 inhibitors, Pioglitazone, Insulin, GLP1Ra or drugs related with NAFLD for more than 12 sequential weeks before first visit in OPD. 5.Use of other drugs such as tamoxifen, methotrexate, amiodarone, systemic gluco-corticoids, tetracyclines, anabolic steroids, high doses of estrogens, oral contraceptives, L-asparaginase, sodium valproate, chloroquine & HIV-drugs. 6.Patient with serum positive Hepatitis-B surface antigen or anti-HCV & those who are contraindicated for SGLT-2 Inhibitors & Pioglitazone were excluded.

Design outcomes

Primary

Measure	Time frame
Change in Liver steatosis/ Fatty liver gradeTimepoint: After three months & six months	—

Secondary

Measure	Time frame
Evaluating quality of life of Non alcoholic fatty liver disease patients with Diabetes MellitusTimepoint: 6 months;Monitoring safety by evaluating any adverse drug reactionsTimepoint: Follow up taken at every week;Prevalence of Non-alcoholic fatty liver disease patients in a tertiary care hospitalTimepoint: 3 months	—

Countries

India

Contacts

Public ContactShilpa

ESIC Medical College and Hospital.

drpraveenmalik@gmail.com9811827454

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026