A Study to Investigate Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Diabetic Patients
- Sponsor
- AstraZeneca
- Study ID
- NCT02279407
- Phase
- PHASE2
- Status
- Completed
Conditions
- T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- placebo — DRUGPlacebo matching to Omega-3 carboxylic acids (olive oil)
- Omega-3 carboxylic acids — DRUG4 g administered as 4 x 1 g capsules
- Dapagliflozin — DRUG10 mg administered as 10 mg tablet
- Placebo — DRUGPlacebo matching to dapagliflozin 10 mg
Study Details
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))
Key Dates
- Start date
- Jan 31, 2015
- Status verified
- Feb 2017
- Primary completion
- Dec 31, 2015
- Completion
- Dec 31, 2015
Study Design
- Enrollment
- 223 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: placebo
- Experimental: Omega-3 carboxylic acids 4g / day
- Experimental: Dapagliflozin, 10mg / day
- Experimental: Omega-3 carboxylic acids 4g/day+Dapagliflozin 10mg/day
Primary Outcome Measure
Change From Baseline to Week 12 in % Liver Fat as Assessed by MRI (Comparison Versus Placebo) [ Time Frame: 12 weeks ]