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

NCT02279407 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 223

Last updated 2017-03-17

Study results available
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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))

Conditions

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

Interventions

DRUG

placebo

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

DRUG

Omega-3 carboxylic acids

4 g administered as 4 x 1 g capsules

DRUG

Dapagliflozin

10 mg administered as 10 mg tablet

DRUG

Placebo

Placebo matching to dapagliflozin 10 mg

Sponsors & Collaborators

  • Uppsala Clinical Research, Uppsala, Sweden

    collaborator UNKNOWN

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Jan Eriksson, MD · Uppsala University Hospital, Uppsala, SE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Sweden

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02279407 on ClinicalTrials.gov