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NCT Number: NCT02279407

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

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))

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Key information

Conditions

T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin) Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Gothenburg, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Placebo

Drug

Placebo matching to Omega-3 carboxylic acids (olive oil)

Omega-3 carboxylic acids

Drug

4 g administered as 4 x 1 g capsules

Dapagliflozin

Drug

10 mg administered as 10 mg tablet

Primary outcomes

  1. Change From Baseline to Week 12 in % Liver Fat as Assessed by MRI (Comparison Versus Placebo)

    Time frame: 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 outcomes

  1. Change From Baseline to Week 12 in % Liver Fat (Comparison Between Active Treatment Groups)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Uppsala Clinical Research, Uppsala, Sweden

Registry information

Official study title

A Double-blind Randomized Placebo-controlled, Parallel-group 12 Week Study to Investigate the Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Type 2 Diabetic Patients; EFFECT II

Acronym: EFFECTII

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 31, 2014
Registry last updated
Mar 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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