CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 223 enrolled
Drug / intervention
placebo +3 moredrug
Likely dose
Omega-3 carboxylic acids 4 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02279407
NCT02279407Phase 2Completed
CompareCT.gov

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

AstraZeneca·interventional·Posted Oct 31, 2014·Updated Mar 17, 2017

In Brief

A Phase 2 clinical trial evaluating placebo, Omega-3 carboxylic acids, and 2 other interventions for T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin). Completed, enrolled 223 participants across 5 sites.

Detailed 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))

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsT2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)
CountriesSweden
CollaboratorsUppsala Clinical Research, Uppsala, Sweden

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 31, 2014
Enrollment StartJan 1, 2015
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.7 years ago

Interventions

placebodrug

Placebo matching to Omega-3 carboxylic acids (olive oil)

Omega-3 carboxylic acidsdrug

4 g administered as 4 x 1 g capsules

Dapagliflozindrug

10 mg administered as 10 mg tablet

Placebodrug

Placebo matching to dapagliflozin 10 mg