T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)Phase 2EFFECTIINCT02279407
A Study to Investigate Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Diabetic Patients
A Phase 2 study testing Omega-3 carboxylic acids and Dapagliflozin in people with T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin), run by AstraZeneca at 5 sites in Sweden.
Trial 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)) Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)
- What is being tested?
- Omega-3 carboxylic acids and Dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 223 participants
- Where
- 5 sitesSweden
- Study dates
- Jan 2015to Dec 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Sweden5 sites
Research Site
Gothenburg
Research Site
Linköping
Research Site
Örebro
Research Site
Stockholm
Research Site
Uppsala
About this study
Official title: 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
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))
- Being tested
- placebo, Omega-3 carboxylic acids, Dapagliflozin
- Keywords
- omega-3 carboxylic acid
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
| Omega-3 carboxylic acids 4g / day | Experimental | Not described Receives: Drug: Omega-3 carboxylic acids |
| Dapagliflozin, 10mg / day | Experimental | Not described Receives: Drug: Dapagliflozin |
| Omega-3 carboxylic acids 4g/day+Dapagliflozin 10mg/day | Experimental | Not described Receives: Drug: Omega-3 carboxylic acids; Drug: Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 12 in % Liver Fat as Assessed by MRI (Comparison Versus Placebo)
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.
Measured: 12 weeks
Secondary outcomes (1)
Change From Baseline to Week 12 in % Liver Fat (Comparison Between Active Treatment Groups)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Uppsala Clinical Research, Uppsala, Sweden
- Responsible party
- Sponsor
- Investigators
- Jan Eriksson, MD, Principal investigator, Uppsala University Hospital, Uppsala, SE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279407
- Sponsor's protocol ID
- D5883C00004
- Acronym
- EFFECTII
- Status last verified
- Feb 2017
- First submitted
- 29 Oct 2014
- Last updated
- 17 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Eriksson JW, Lundkvist P, Jansson PA, Johansson L, Kvarnstrom M, Moris L, Miliotis T, Forsberg GB, Riserus U, Lind L, Oscarsson J. Effects of dapagliflozin and n-3 carboxylic acids on non-alcoholic fatty liver disease in people with type 2 diabetes: a double-blind randomised placebo-controlled study. Diabetologia. 2018 Sep;61(9):1923-1934. doi: 10.1007/s00125-018-4675-2. Epub 2018 Jul 3.
PubMed 29971527
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02279407
- Acronym / sponsor ID
- EFFECTII / D5883C00004
- Keywords
- omega-3 carboxylic acid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Uppsala Clinical Research, Uppsala, Sweden
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Posted 27 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebo |
| Omega-3 carboxylic acids 4g / day | Experimental | Drug: Omega-3 carboxylic acids |
| Dapagliflozin, 10mg / day | Experimental | Drug: Dapagliflozin |
| Omega-3 carboxylic acids 4g/day+Dapagliflozin 10mg/day | Experimental | Drug: Omega-3 carboxylic acids, Drug: Dapagliflozin |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboPlacebo matching to Omega-3 carboxylic acids (olive oil) | Drug | placebo |
| Omega-3 carboxylic acids4 g administered as 4 x 1 g capsules | Drug | Omega-3 carboxylic acids 4g / day, Omega-3 carboxylic acids 4g/day+Dapagliflozin 10mg/day |
| Dapagliflozin10 mg administered as 10 mg tablet | Drug | Dapagliflozin, 10mg / day, Omega-3 carboxylic acids 4g/day+Dapagliflozin 10mg/day |
| PlaceboPlacebo matching to dapagliflozin 10 mg | Drug | placebo |
Primary outcome
Change From Baseline to Week 12 in % Liver Fat as Assessed by MRI (Comparison Versus Placebo)
Time frame: 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.
1 secondary outcome
Change From Baseline to Week 12 in % Liver Fat (Comparison Between Active Treatment Groups)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29971527Eriksson JW, Lundkvist P, Jansson PA, Johansson L, Kvarnstrom M, Moris L, Miliotis T, Forsberg GB, Riserus U, Lind L, Oscarsson J. Effects of dapagliflozin and n-3 carboxylic acids on non-alcoholic fatty liver disease in people with type 2 diabetes: a double-blind randomised placebo-controlled study. Diabetologia. 2018 Sep;61(9):1923-1934. doi: 10.1007/s00125-018-4675-2. Epub 2018 Jul 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Eriksson, MD principal investigator
Uppsala University Hospital, Uppsala, SE
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omega-3 carboxylic acids and Dapagliflozin in people with T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin), run by AstraZeneca at 5 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Week 12 in % Liver Fat as Assessed by MRI (Comparison Versus Placebo) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02279407, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2017.