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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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))

A study to investigate effects of Omega-3 carboxylic acids and dapagliflozin on liver fat content in diabetic patients

NCT ID

Therapeutic Area

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

Research Site

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

To evaluate the efficacy of the combination therapy (Omega-3 carboxylic acids + dapagliflozin) when compared to placebo with respect to reduction in liver fat content (%) at the end of 12 weeks of double-blinded treatment.

Age Continuous

Age, Customized

Gender, Male/Female

Race, Customized

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.

The Full Analysis Set included all randomized patients, regardless of whether they took trial medication or not.  In this set, patients were analyzed according to their randomized treatment assignment.

Change from Baseline to Week 12 in % liver fat as assessed by MRI (comparison versus placebo)

To evaluate the relative efficacy of the combination of Epanova and dapagliflozin versus Epanova alone and dapagliflozin alone with respect to reduction in % liver fat at the end of 12 weeks of double-blind 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.

Change from Baseline to Week 12 in % liver fat (comparison between active treatment groups)

Overall Study

The study duration was up to 15 weeks: an screening period of up to 2 weeks, a 12-week treatment period, and a follow-up visit 1 week after the last dose of study drug. A total of 223 patients signed informed consent; data was not recorded for 1 patient and 18 were screened twice. Therefore, 204 patients were screened, and 84 were randomized.

Stefan Carlsson

To evaluate the relative efficacy between Omega-3 carboxylic acids + dapagliflozin, Omega-3 carboxylic acids, dapagliflozin and placebo with respect to reduction in liver fat at the end of 12 weeks of double-blind treatment.

Arms	Assigned Interventions
Placebo Comparator: placebo	Drug: placebo Placebo matching to Omega-3 carboxylic acids (olive oil) Drug: Placebo Placebo matching to dapagliflozin 10 mg
Experimental: Omega-3 carboxylic acids 4g / day	Drug: Omega-3 carboxylic acids 4 g administered as 4 x 1 g capsules
Experimental: Dapagliflozin, 10mg / day	Drug: Dapagliflozin 10 mg administered as 10 mg tablet
Experimental: Omega-3 carboxylic acids 4g/day+Dapagliflozin 10mg/day	Drug: Omega-3 carboxylic acids 4 g administered as 4 x 1 g capsules Drug: Dapagliflozin 10 mg administered as 10 mg tablet

A study to investigate effects of Omega-3 carboxylic acids and dapagliflozin on liver fat content in diabetic patients - EFFECTII

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