Patients with type 2-diabetes who have Non-alcoholic fatty liver disease (NAFLD)
Conditions
Interventions
Trade Name: Epanova
Product Name: Epanova
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: omega-3-carboxylic acid
Current Sponsor code: OMEFAS
Other descriptive name: OMEGA-3 FATTY ACIDS
Conce
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Provision of Informed consent - 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%. - Type 2 diabetes since at least 6 months in accordance with WHO criteria - Body mass index (BMI) = 25 and = 40kg/m2. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 32 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 48
Exclusion criteria
Exclusion criteria: - History of or presence of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study. - Creatinine clearence 3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN. - Use of insulin or GLP-1 therapy or other OADs than metformin ir sulfonylurea within the last 4 weeks prior to visit 1 - Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the Investigator. This includes signs of liver disease other than NAFLD that motivates further investigations or treament based on clinical judgement. - Recent history (past 12 months) of drug or alcohol abuse. Alcohol abuse is defined as > 14 drinks per week (1 drink= 35cl beer, 14 cl wine or 4 cl hard liquor) or as judged by the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: To evaluate the relative efficacy between Epanova® + dapagliflozin, Epanova®, dapagliflozin and placebo with respect to reduction in liver fat at the end of 12 weeks of double-blind treatment.;Primary end point(s): Change from baseline to week 12 in the % liver fat content (µ) as measured by magnetic resonance imaging (MRI).;Timepoint(s) of evaluation of this end point: After 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline to week 12 in the % liver fat content (µ) as measured by magnetic resonance imaging (MRI).;Timepoint(s) of evaluation of this end point: After 12 weeks of treatment | — |
Countries
Sweden
Contacts
Public ContactInformation center
AstraZeneca AB
Outcome results
None listed