Status:
COMPLETED
A Study to Investigate Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Diabetic Patients
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Uppsala Clinical Research, Uppsala, Sweden
Conditions:
T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT02279407
Start Date
January 1 2015
End Date
December 1 2015
Last Update
March 17 2017
Active Locations (5)
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1
Research Site
Gothenburg, Sweden
2
Research Site
Linköping, Sweden
3
Research Site
Örebro, Sweden
4
Research Site
Stockholm, Sweden