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A Trial to See Which Diabetes Medicine Better Improves Fatty Liver Scores

Comparison of Efficacy of Dapagliflozin versus Sitagliptin in Diabetes Mellitus patients with Metabolic dysfunction associated fatty liver disease (MAFLD) using Fatty Liver Index (FLI) scores- A Randomised Controlled Trial. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/103440
Enrollment
124
Registered
2026-02-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: E11- Type 2 diabetes mellitus

Interventions

Intervention1: DAPAGLIFLOZIN 10mg orally once a day for 3 months: Individuals with Ultrasound proven MAFLD and DM having Fatty Liver Index more than 30 are selected and divided into two group and Inte

Sponsors

Dr Marshal S
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age more than 18 years Patients diagnosed with fatty liver disease (FLI) more than or equal to 30 Patients diagnosed as T2DM (HbA1c of 7 to 10%)

Exclusion criteria

Exclusion criteria: History of liver disease such as liver cancer, fibrosis and cirrhosis of the liver Hepatitis B, hepatitis C Autoimmune hepatitis and cholangitis Active infections Patients already on SGLT2, Insulin, DPP4 inhibitors, NSAIDs, vitamin E, amiodarone, corticosteroid, methotrexate, sodium valproate, antioxidant. Chronic Alcohol consumption CKD with eGFR less than 45

Design outcomes

Primary

MeasureTime frame
Diabetes patients with MAFLD and who were newly prescribed Dapagliflozin showed significantly better improvement in liver enzymes, reduction in body mass index and waist circumference and a decrease in FLI than those who where newly prescribed Sitagliptin Timepoint: 3 months after administration of the drugs. To check for FLI Score.

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr SN Meenakshi Sundari

SRM Medical College Hospital and Research Centre

joemarshal856@gmail.com9488431995

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026