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

Phase 2

Completed

• Conditions: T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)
• Interventions: Drug: Placebo; Drug: Omega-3 carboxylic acids; Drug: Dapagliflozin

• Registration Number: NCT02279407
• Lead Sponsor: AstraZeneca

Brief Summary

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))

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-29
• Study First Submitted QC: 2014-10-29
• Study First Posted: 2014-10-31
• Study Start: 2015-01
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Results First Submitted: 2016-12-02
• Results First Submitted QC: 2016-12-02
• Results First Posted: 2017-01-27
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 223

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	-
Omega-3 carboxylic acids 4g / day	Omega-3 carboxylic acids	-
Omega-3 carboxylic acids 4g/day+Dapagliflozin 10mg/day	Omega-3 carboxylic acids	-
Dapagliflozin, 10mg / day	Dapagliflozin	-
Omega-3 carboxylic acids 4g/day+Dapagliflozin 10mg/day	Dapagliflozin	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 12 in % Liver Fat as Assessed by MRI (Comparison Versus Placebo)	12 weeks	To evaluate the efficacy of the combination therapy (Epanova + Dapagliflozin) when compared to placebo with respect to reduction in liver fat content (%) at the end of 12 weeks of double-blinded treatment. Treatment effect in liver fat reduction (%) was assessed using a mixed linear model with the change from baseline on logarithmic scale as response variable and the logarithm of the baseline value as covariate, treatment as fixed effect, and center as random effect. The treatment effect was then back-transformed to original scale as Geometric mean ratio and presented as percentage change from baseline.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Week 12 in % Liver Fat (Comparison Between Active Treatment Groups)	12 weeks	To evaluate the relative efficacy of the combination of Epanova and dapagliflozin versus Epanova alone and dapagliflozin alone with respect to reduction in % liver fat at the end of 12 weeks of double-blind treatment. Treatment effect in liver fat reduction (%) was assessed using a mixed linear model with the change from baseline on logarithmic scale as response variable and the logarithm of the baseline value as covariate, treatment as fixed effect, and center as random effect. The treatment effect was then back-transformed to original scale as Geometric mean ratio and presented as percentage change from baseline.

Trial Locations

Locations (1)

Research Site; 🇸🇪 Örebro, Sweden