Phase 2
Completed N=84
A Study to Investigate Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Diabetic Patients
T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)
Source: ClinicalTrials.gov NCT02279407 ↗
Enrolled (actual)
84
Serious AEs
2.4%
Results posted
Jan 2017
Primary outcomePrimary: Change From Baseline to Week 12 in % Liver Fat as Assessed by MRI (Comparison Versus Placebo) — 0.79; 0.97 ratio of % liver fat — p=0.046
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 liver fat in patients with Type 2 diabetes with fatty liver (>5.5% as measured with magnetic resonance imaging (MRI))
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 12 in % Liver Fat as Assessed by MRI (Comparison Versus Placebo) |
0.79; 0.97 | 0.046 sig |
| SECONDARY Change From Baseline to Week 12 in % Liver Fat (Comparison Between Active Treatment Groups) |
0.79; 0.87; 0.85 | 0.502 |
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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).
Data sourced from ClinicalTrials.gov (NCT02279407). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.