A Study to Compare the Efficacy of Dapagliflozin and Teneligliptin on Liver Fat and Metabolism in People with Type 2 Diabetes and Fatty Liver Disease.

A Open-label Randomized controlled trial to compare the efficacy of Dapagliflozin and Teneligliptin on liver fat reduction and on Metabolic Parameters in type 2 Diabetes patients with MAFLD - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/093475

Enrollment

Registered

2025-08-22

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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: Dapagliflozin. : Dapagliflozin OD for 12 week Control Intervention1: Teneligliptin: Teneligliptin 20 mg OD for 12 weeek

Eligibility

Inclusion criteria

Inclusion criteria: Adults Patients aged 20?65 years diagnosed with MAFLD giving written informed consent . T2DM patient with MAFLD eligible for treatment with Dapagliflozin or Teneligliptin . Diagnosed with MAFLD based on imaging evidence of hepatic steatosis and metabolic dysfunction.

Exclusion criteria

Exclusion criteria: Type 1 diabetic mellitus History of other chronic liver disease Eg Viral hepatitis autoimmune hepatitis alcohol related liver disease. History of chronic kideny disease, eGFR less than 30 ml per min per 1.73m2. History of alcohol intake more than 30 mg/day in men,more than 20mg/day in women. Pregnancy or lactation History of ischemic heart disease. Cognitively impaired.

Design outcomes

Primary

Measure	Time frame
Change in the liver fat content measured by USG.Timepoint: 12 week	—

Secondary

Measure	Time frame
Changes in glycemic parameter.LFT,Lipid profile,BP,BMI.Timepoint: 12 week	—

Countries

India

Contacts

Public ContactJaideep CK

AIIMS BIBINAGAR

bisoidebasis@gmail.com9437213656

Outcome results

None listed

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