A double-blind randomized placebo-controlled, parallel-group study during 12 weeks to investigate whether the drugs Epanova® and dapagliflozin can dimish the liver fat content in patients with diabetes type 2.
- Conditions
- Patients with type 2-diabetes who have Non-alcoholic fatty liver disease(NAFLD)Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2014-003638-26-SE
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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 <60 mL/min at screening (Cockcroft-Gault formula).
- Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of the combination therapy (Epanova® +<br>dapagliflozin) when compared to placebo with respect to reduction in<br>liver fat content (%) at the end of 12 weeks of double-blinded<br>treatment.;Secondary Objective: To evaluate the relative efficacy between Epanova® + dapagliflozin,<br>Epanova®, dapagliflozin and placebo with respect to reduction in liver<br>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 Outcome Measures
Name Time Method 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