Trial · NCT02279407
A Study to Investigate Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Diabetic Patients
NCT02279407, Phase 2, Completed, AstraZeneca; results first posted 2017-01-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Investigate Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Diabetic Patients. Trials, record NCT02279407. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02279407
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Diabetic Patients
- NCT number
- NCT02279407
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 223 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)
- Interventions
- placebo, Omega-3 carboxylic acids, Dapagliflozin, Placebo
- First posted
- 2014-10-31
- Last updated
- 2017-03-17
- Results first posted
- 2017-01-27
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 12 in % Liver Fat as Assessed by MRI (Comparison Versus Placebo) | 12 weeks | 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. |
| Secondary | Change From Baseline to Week 12 in % Liver Fat (Comparison Between Active Treatment Groups) | 12 weeks | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 12 in % Liver Fat as Assessed by MRI (Comparison Versus Placebo) | 12 weeks | 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. | ratio of % liver fat | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline to Week 12 in % Liver Fat (Comparison Between Active Treatment Groups) | 12 weeks | 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. | ratio of % liver fat | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 12 in % Liver Fat as Assessed by MRI (Comparison Versus Placebo) | Epanova + Dapagliflozin | 0.79 | 95% Confidence Interval 0.69 to 0.90 | ratio of % liver fat | |
| Change From Baseline to Week 12 in % Liver Fat as Assessed by MRI (Comparison Versus Placebo) | Placebo | 0.97 | 95% Confidence Interval 0.90 to 1.04 | ratio of % liver fat | |
| Change From Baseline to Week 12 in % Liver Fat (Comparison Between Active Treatment Groups) | Epanova + Dapagliflozin | 0.79 | 95% Confidence Interval 0.69 to 0.90 | ratio of % liver fat | |
| Change From Baseline to Week 12 in % Liver Fat (Comparison Between Active Treatment Groups) | Dapagliflozin | 0.87 | 95% Confidence Interval 0.77 to 0.99 | ratio of % liver fat | |
| Change From Baseline to Week 12 in % Liver Fat (Comparison Between Active Treatment Groups) | Epanova | 0.85 | 95% Confidence Interval 0.78 to 0.92 | ratio of % liver fat |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Epanova + Dapagliflozin | 22 | |
| Overall Study | STARTED | Dapagliflozin | 21 | |
| Overall Study | STARTED | Epanova | 20 | |
| Overall Study | STARTED | Placebo | 21 | |
| Overall Study | COMPLETED | Epanova + Dapagliflozin | 20 | |
| Overall Study | COMPLETED | Dapagliflozin | 20 | |
| Overall Study | COMPLETED | Epanova | 15 | |
| Overall Study | COMPLETED | Placebo | 20 | |
| Overall Study | NOT COMPLETED | Epanova + Dapagliflozin | 2 | |
| Overall Study | NOT COMPLETED | Dapagliflozin | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events40
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain upper | Gastrointestinal disorders | Epanova + Dapagliflozin | 3 | 22 | 3 |
| other | Abdominal pain upper | Gastrointestinal disorders | Epanova | 2 | 20 | 2 |
| other | Abdominal pain upper | Gastrointestinal disorders | Dapagliflozin | 0 | 21 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 0 | 21 | 0 |
| other | Constipation | Gastrointestinal disorders | Epanova + Dapagliflozin | 0 | 22 | 0 |
| other | Constipation | Gastrointestinal disorders | Epanova | 1 | 20 | 1 |
| other | Constipation | Gastrointestinal disorders | Dapagliflozin | 2 | 21 | 2 |
| other | Constipation | Gastrointestinal disorders | Placebo | 1 | 21 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Epanova + Dapagliflozin | 11 | 22 | 12 |
| other | Diarrhoea | Gastrointestinal disorders | Epanova | 7 | 20 | 7 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Epanova + Dapagliflozin | ||
| Total, all-cause mortality | Epanova | ||
| Total, all-cause mortality | Dapagliflozin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Epanova + Dapagliflozin | 14 | 22 |
| Total, other adverse events | Epanova | 12 | 20 |
| Total, other adverse events | Dapagliflozin | 8 | 21 |
| Total, other adverse events | Placebo | 7 | 21 |
| Total, serious adverse events | Epanova + Dapagliflozin | 0 | 22 |
| Total, serious adverse events | Epanova | 0 | 20 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29971527 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02279407
GET https://conductscience.org/api/trials/v1/NCT02279407/events?page=2