Effect of Dapagliflozin vs Sitagliptin on Liver Fat Accumulation and Body Composition in Patients With Diabetes Mellitus and Liver Transplantation (Dapa-LiT)
Diabetes Mellitus, Liver Transplant; Complications
About this trial
This is an interventional treatment trial for Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of diabetes (pre-transplantation type 2 diabetes or new onset diabetes after transplantation)
- Insulin use for at least 3 months since liver transplantation
- Subjects must be on a total insulin dose of >=0.3 U/kg/day for at least 3 months.
- Body mass index (BMI) >=18.5 kg/m2
Exclusion Criteria:
- Type 1 diabetes
- Estimated glomerular filtration rate (eGFR) <45 ml/min/1.73 m2, calculated by the Chronic Kidney Disease - Epidemiology (CKD-EPI) equation
- Liver aminotransferases >3 times the upper limit of the reference range (upper normal limit AST or ALT >=40 units/L)
- History of recurrent urinary tract infection
- History or current acute or chronic pancreatitis
- Pregnancy
- Presence of major contraindications to magnetic resonance imaging (cardiac pacemakers, claustrophobia, foreign bodies and implanted medical devices with ferromagnetic properties).
Sites / Locations
- Division Of Endocrinology & Diabetes, Medanta The MedicityRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Dapa Group
Sita Group
Patients with diabetes mellitus will receive dapagliflozin 10 mg once daily. Glycemic equipoise will be maintained between the two groups by adjusting insulin doses and/or metformin and/or sulfonylurea; maintaining target fasting glucose, post-prandial glucose and glycated hemoglobin (HbA1c) in accordance with the ADA 2021
Patients with diabetes mellitus will receive sitagliptin 100 mg once daily.Glycemic equipoise will be maintained between the two groups by adjusting insulin doses and/or metformin and/or sulfonylurea; maintaining target fasting glucose, post-prandial glucose and glycated hemoglobin (HbA1c) in accordance with the ADA 2021