Effect of Metformin in combination with Empagliflozin and Linagliptin separately and simultaneously on Clinical and Paraclinical Outcomes in type 2 diabetic patients with metabolic fatty liver

Effect of Metformin in combination with Empagliflozin and Linagliptin separately and simultaneously on Clinical and Paraclinical Outcomes in type 2 diabetic patients with metabolic fatty liver: A randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120215009014N601

Enrollment

Registered

2026-04-11

Start date

2026-04-30

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Fatty liver. Fatty (change of) liver, not elsewhere classified

Interventions

Intervention 1: Intervention group 1: Metformin tablets 1000 to 2000 mg once daily plus empagliflozin tablets 10 mg once daily for 24 weeks. Intervention 2: Intervention group 2: Metformin tablets 100

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Age 18 to 75 years, Type 2 diabetes for at least 6 months, Fatty liver with metabolic dysfunction, Hemoglobin A1c between 6.8 and 9.0 percent, Body mass index between 25 and 40 kg/m2,

Exclusion criteria

Exclusion criteria: Pregnancy or lactation, Heart disease, Liver failure, Alcohol or substance abuse

Design outcomes

Primary

Measure	Time frame
Changes in liver stiffness. Timepoint: Before intervention and 24 months later. Method of measurement: using the FibroScan method.;Changes in Fibrosis Index-4 (FIB-4). Timepoint: Before intervention and 24 months later. Method of measurement: Based on laboratory centers.;Changes in serum body enzymes AST and ALT. Timepoint: Before intervention and 24 months later. Method of measurement: By taking blood samples.;Changes in body mass index (BMI) and waist circumference. Timepoint: Before intervention and 24 months later. Method of measurement: Based on clinical examination and measurement.;Changes in lipid profile including TG, TC, LDL-C and HDL-C. Timepoint: before intervention and 24 months later. Method of measurement: By taking blood samples.;Changes in glucose metabolism indices including FBS, HbA1c and HOMA-IR. Timepoint: Before intervention and 24 months later. Method of measurement: by taking blood samples.	—

Measure

Time frame

Changes in liver stiffness. Timepoint: Before intervention and 24 months later. Method of measurement: using the FibroScan method.;Changes in Fibrosis Index-4 (FIB-4). Timepoint: Before intervention and 24 months later. Method of measurement: Based on laboratory centers.;Changes in serum body enzymes AST and ALT. Timepoint: Before intervention and 24 months later. Method of measurement: By taking blood samples.;Changes in body mass index (BMI) and waist circumference. Timepoint: Before intervention and 24 months later. Method of measurement: Based on clinical examination and measurement.;Changes in lipid profile including TG, TC, LDL-C and HDL-C. Timepoint: before intervention and 24 months later. Method of measurement: By taking blood samples.;Changes in glucose metabolism indices including FBS, HbA1c and HOMA-IR. Timepoint: Before intervention and 24 months later. Method of measurement: by taking blood samples.

—

Secondary

Measure	Time frame
Frequency and types of complications including dizziness, nausea, vomiting and skin rash. Timepoint: During 24 months after intervention. Method of measurement: Based on taking patient history.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBahar Seifi Zarei

Hamedan University of Medical Sciences

bahar.seifizarei@gmail.com+98 81 3838 0572

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026