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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 223
- 试验地点
- 1
- 主要终点
- Change From Baseline to Week 12 in % Liver Fat as Assessed by MRI (Comparison Versus Placebo)
研究概览
简要总结
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))
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Omega-3 carboxylic acids 4g/day+Dapagliflozin 10mg/day
干预措施: Omega-3 carboxylic acids (Drug)
placebo
干预措施: Placebo (Drug)
Omega-3 carboxylic acids 4g / day
干预措施: Omega-3 carboxylic acids (Drug)
Dapagliflozin, 10mg / day
干预措施: Dapagliflozin (Drug)
Omega-3 carboxylic acids 4g/day+Dapagliflozin 10mg/day
干预措施: Dapagliflozin (Drug)
结局指标
主要结局
Change From Baseline to Week 12 in % Liver Fat as Assessed by MRI (Comparison Versus Placebo)
时间窗: 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.
次要结局
- Change From Baseline to Week 12 in % Liver Fat (Comparison Between Active Treatment Groups)(12 weeks)