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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
placebo
Omega-3 carboxylic acids
Dapagliflozin
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin) focused on measuring omega-3 carboxylic acid

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

placebo

Omega-3 carboxylic acids 4g / day

Dapagliflozin, 10mg / day

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

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 29, 2014
Last Updated
February 9, 2017
Sponsor
AstraZeneca
Collaborators
Uppsala Clinical Research, Uppsala, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT02279407
Brief Title
A Study to Investigate Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Diabetic Patients
Acronym
EFFECTII
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Uppsala Clinical Research, Uppsala, Sweden

4. Oversight

Data Monitoring Committee
No

5. Study Description

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))

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)
Keywords
omega-3 carboxylic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
223 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
Omega-3 carboxylic acids 4g / day
Arm Type
Experimental
Arm Title
Dapagliflozin, 10mg / day
Arm Type
Experimental
Arm Title
Omega-3 carboxylic acids 4g/day+Dapagliflozin 10mg/day
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo matching to Omega-3 carboxylic acids (olive oil)
Intervention Type
Drug
Intervention Name(s)
Omega-3 carboxylic acids
Intervention Description
4 g administered as 4 x 1 g capsules
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Intervention Description
10 mg administered as 10 mg tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching to dapagliflozin 10 mg
Primary Outcome Measure Information:
Title
Change From Baseline to Week 12 in % Liver Fat as Assessed by MRI (Comparison Versus Placebo)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 12 in % Liver Fat (Comparison Between Active Treatment Groups)
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Eriksson, MD
Organizational Affiliation
Uppsala University Hospital, Uppsala, SE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Göteborg
Country
Sweden
Facility Name
Research Site
City
Linkoping
Country
Sweden
Facility Name
Research Site
City
Stockholm
Country
Sweden
Facility Name
Research Site
City
Uppsala
Country
Sweden
Facility Name
Research Site
City
Örebro
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
29971527
Citation
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.
Results Reference
derived

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

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