A Study to Investigate Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Diabetic Patients (EFFECTII)
T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)
About this trial
This is an interventional treatment trial for T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin) focused on measuring omega-3 carboxylic acid
Eligibility Criteria
Inclusion Criteria: Provision of informed consent prior to any study specific procedures; Men or women ≥40 years and ≤75 years with suitable veins for cannulation or repeated venepuncture; Have liver fat content as assessed by MRI >5.5%; Diagnosis of Type 2 diabetes since at least 6 months in accordance with WHO criteria.
Exclusion Criteria: Any condition when MRI is contraindicated such as, but not limited to, having a pacemaker or claustrophobia; Diagnosis or signs of Type 1 diabetes (e.g. history of positive islet antibodies); Creatinine clearance <60 mL/min at screening (Cockcroft-Gault formula).
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Experimental
Experimental
Experimental
placebo
Omega-3 carboxylic acids 4g / day
Dapagliflozin, 10mg / day
Omega-3 carboxylic acids 4g/day+Dapagliflozin 10mg/day