A double-blind randomized placebo-controlled, parallel-group 12 week study to investigate the effects of Epanova® and dapagliFlozin on liver Fat contEnt in type 2 diabetiC patienTs; - EFFECT II

AstraZeneca AB0 个研究点开始时间: 2014年10月3日最近更新: 2016年4月11日

适应症

试验速览

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•- 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

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