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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02279407
Recruitment Status : Completed
First Posted : October 31, 2014
Results First Posted : January 27, 2017
Last Update Posted : March 17, 2017
Sponsor:
Collaborator:
Uppsala Clinical Research, Uppsala, Sweden
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE October 29, 2014
First Posted Date  ICMJE October 31, 2014
Results First Submitted Date  ICMJE December 2, 2016
Results First Posted Date  ICMJE January 27, 2017
Last Update Posted Date March 17, 2017
Study Start Date  ICMJE January 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 29, 2014)
Change from baseline to week 12 in the % liver fat content as measured by MRI. [ Time Frame: 12 weeks ]
To evaluate the efficacy of the combination therapy (Omega-3 carboxylic acids + dapagliflozin) when compared to placebo with respect to reduction in liver fat content (%) at the end of 12 weeks of double-blinded treatment.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2017)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2014)
Change from baseline to week 12 in the % liver fat content as measured by MRI. [ Time Frame: 12 weeks ]
To evaluate the relative efficacy between Omega-3 carboxylic acids + dapagliflozin, Omega-3 carboxylic acids, dapagliflozin and placebo with respect to reduction in liver fat at the end of 12 weeks of double-blind treatment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Investigate Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Diabetic Patients
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Placebo Comparator: placebo
    Interventions:
    • Drug: placebo
    • Drug: Placebo
  • Experimental: Omega-3 carboxylic acids 4g / day
    Intervention: Drug: Omega-3 carboxylic acids
  • Experimental: Dapagliflozin, 10mg / day
    Intervention: Drug: Dapagliflozin
  • Experimental: Omega-3 carboxylic acids 4g/day+Dapagliflozin 10mg/day
    Interventions:
    • Drug: Omega-3 carboxylic acids
    • Drug: Dapagliflozin
Publications * Eriksson JW, Lundkvist P, Jansson PA, Johansson L, Kvarnström M, Moris L, Miliotis T, Forsberg GB, Risérus 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2016)
223
Original Estimated Enrollment  ICMJE
 (submitted: October 29, 2014)
100
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02279407
Other Study ID Numbers  ICMJE D5883C00004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Uppsala Clinical Research, Uppsala, Sweden
Investigators  ICMJE
Principal Investigator: Jan Eriksson, MD Uppsala University Hospital, Uppsala, SE
PRS Account AstraZeneca
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP