A Study to Investigate Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Diabetic Patients (EFFECTII)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)

Treatments: Drug: Dapagliflozin; Drug: Placebo; Drug: Omega-3 carboxylic acids; Drug: placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02279407

D5883C00004

Details and patient eligibility

About

This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study performed in up to 5 centres in Sweden to assess the effect of Omega-3 carboxylic acids and dapagliflozin on liver fat in patients with Type 2 diabetes with fatty liver (>5.5% as measured with magnetic resonance imaging (MRI))

Enrollment: 223 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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223 participants in 4 patient groups, including a placebo group

placebo

Placebo Comparator group

Treatment:

Drug: placebo

Omega-3 carboxylic acids 4g / day

Experimental group

Treatment:

Drug: Omega-3 carboxylic acids

Dapagliflozin, 10mg / day

Experimental group

Treatment:

Drug: Dapagliflozin

Omega-3 carboxylic acids 4g/day+Dapagliflozin 10mg/day

Experimental group

Treatment:

Drug: Omega-3 carboxylic acids

Drug: Dapagliflozin