NCT02279407

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))

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 27, 2017

Completed
Last Updated

March 17, 2017

Status Verified

February 1, 2017

Enrollment Period

11 months

First QC Date

October 29, 2014

Results QC Date

December 2, 2016

Last Update Submit

February 9, 2017

Conditions

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

Keywords

omega-3 carboxylic acid

Outcome Measures

Primary Outcomes (1)

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

    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.

    12 weeks

Secondary Outcomes (1)

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

    12 weeks

Study Arms (4)

placebo

PLACEBO COMPARATOR
Drug: placebo

Omega-3 carboxylic acids 4g / day

EXPERIMENTAL
Drug: Omega-3 carboxylic acids

Dapagliflozin, 10mg / day

EXPERIMENTAL
Drug: Dapagliflozin

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

EXPERIMENTAL
Drug: Omega-3 carboxylic acidsDrug: Dapagliflozin

Interventions

PlaceboDRUG

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

placebo
Omega-3 carboxylic acidsDRUG

4 g administered as 4 x 1 g capsules

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

10 mg administered as 10 mg tablet

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

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Research Site

Gothenburg, Sweden

Location

Research Site

Linköping, Sweden

Location

Research Site

Örebro, Sweden

Location

Research Site

Stockholm, Sweden

Location

Research Site

Uppsala, Sweden

Location

Related Publications (1)

  • Eriksson JW, Lundkvist P, Jansson PA, Johansson L, Kvarnstrom M, Moris L, Miliotis T, Forsberg GB, Riserus U, Lind L, Oscarsson J. Effects of dapagliflozin and n-3 carboxylic acids on non-alcoholic fatty liver disease in people with type 2 diabetes: a double-blind randomised placebo-controlled study. Diabetologia. 2018 Sep;61(9):1923-1934. doi: 10.1007/s00125-018-4675-2. Epub 2018 Jul 3.

    PMID: 29971527DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Results Point of Contact

Title
Stefan Carlsson
Organization
AstraZeneca
Stefan.C.Carlsson@astrazeneca.com

Study Officials

  • Jan Eriksson, MD

    Uppsala University Hospital, Uppsala, SE

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2014

First Posted

October 31, 2014

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 17, 2017

Results First Posted

January 27, 2017

Record last verified: 2017-02

Locations

SE(5)