Clinical trial No longer in our active list Interventional

Comparing Dapagliflozin and Sitagliptin for Liver Fat in Diabetic Liver Transplant Patients

Official title: Effect of Dapagliflozin vs Sitagliptin on Liver Fat Accumulation and Body Composition in Patients With Diabetes Mellitus and Liver Transplantation: a Randomized Controlled Trial

Run by Medanta, The Medicity, India · NCT05042505 · Data updated 2026-05-14

This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.

This study is testing whether the medications dapagliflozin or sitagliptin can help reduce liver fat in people with diabetes who have had a liver transplant.

More Diabetes Mellitus trials

Quick facts

Study typeInterventional
SexAll
Enrollment100 (estimated)
SponsorMedanta, The Medicity, India
Academic / other
Locations1 site (Gurgaon, Haryana)
Trial IDNCT05042505 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients with type 2 diabetes who are undergoing or have undergone liver transplantation.

Probably not a fit

Patients with type 1 diabetes or significant kidney dysfunction may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of dapagliflozin versus sitagliptin on liver fat accumulation and body composition in patients with diabetes mellitus who have undergone liver transplantation. The study aims to enroll 100 patients, including those with pre-transplant type 2 diabetes and new-onset diabetes after transplantation. Participants will receive either dapagliflozin or sitagliptin, and their outcomes will be assessed through various demographic, clinical, and laboratory parameters. The trial is conducted following ethical guidelines and requires informed consent from all participants.

Why it matters

Potential benefit: If successful, this study could provide insights into effective management strategies for diabetes in liver transplant patients, potentially reducing liver fat accumulation.

How similar studies have gone: While there is limited data on the specific use of dapagliflozin and sitagliptin in this population, SGLT-2 inhibitors have shown promise in managing liver fat in other contexts.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Diagnosis of diabetes (pre-transplantation type 2 diabetes or new onset diabetes after transplantation)
2. Subjects taking insulin and/or metformin and/or sulfonylurea.
3. Body mass index (BMI) \>=18.5 kg/m2

Exclusion Criteria:

1. Type 1 diabetes
2. Estimated glomerular filtration rate (eGFR) \<45 ml/min/1.73 m2, calculated by the Chronic Kidney Disease - Epidemiology (CKD-EPI) equation
3. Liver aminotransferases \>3 times the upper limit of the reference range (upper normal limit AST or ALT \>=40 units/L)
4. History of recurrent urinary tract infection
5. History or current acute or chronic pancreatitis
6. Pregnancy
7. Presence of major contraindications to magnetic resonance imaging (cardiac pacemakers, claustrophobia, foreign bodies and implanted medical devices with ferromagnetic properties).

Where it's running

  • Division Of Endocrinology & Diabetes, Medanta The Medicity
    Gurgaon, Haryana, India
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.