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| Name | Class |
|---|---|
| Uppsala Clinical Research, Uppsala, Sweden | UNKNOWN |
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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))
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator |
| |
| Omega-3 carboxylic acids 4g / day | Experimental |
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| Dapagliflozin, 10mg / day | Experimental |
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| Omega-3 carboxylic acids 4g/day+Dapagliflozin 10mg/day | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | Placebo matching to Omega-3 carboxylic acids (olive oil) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Jan Eriksson, MD | Uppsala University Hospital, Uppsala, SE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Gothenburg | Sweden | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29971527 | Derived | 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. |
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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.
This study was conducted in 5 centers in Sweden between 20 January 2015 and 11 December 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Epanova + Dapagliflozin | Epanova 4 g/day + Dapagliflozin 10 mg/day |
| FG001 | Dapagliflozin | Dapagliflozin 10 mg/day + placebo to Epanova |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Omega-3 carboxylic acids |
| Drug |
4 g administered as 4 x 1 g capsules |
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| Dapagliflozin | Drug | 10 mg administered as 10 mg tablet |
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| Placebo | Drug | Placebo matching to dapagliflozin 10 mg |
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| 12 weeks |
| Linköping |
| Sweden |
| Research Site | Örebro | Sweden |
| Research Site | Stockholm | Sweden |
| Research Site | Uppsala | Sweden |
| FG002 | Epanova | Epanova 4 g/day + placebo to Dapagliflozin |
| FG003 | Placebo | Placebo to Epanova and placebo to Dapagliflozin |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Epanova + Dapagliflozin | Epanova 4 g/day + Dapagliflozin 10 mg/day |
| BG001 | Epanova | Epanova 4 g/day + placebo to Dapagliflozin |
| BG002 | Dapagliflozin | Dapagliflozin 10 mg/day + placebo to Epanova |
| BG003 | Placebo | Placebo to Epanova and placebo to Dapagliflozin |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | ratio of % liver fat | 12 weeks |
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| Secondary | 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | ratio of % liver fat | 12 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Epanova + Dapagliflozin | Epanova 4 g/day + Dapagliflozin 10 mg/day | 0 | 22 | 14 | 22 | ||
| EG001 | Epanova | Epanova 4 g/day + placebo to Dapagliflozin | 0 | 20 | 12 | 20 | ||
| EG002 | Dapagliflozin | Dapagliflozin 10 mg/day + placebo to Epanova | 1 | 21 | 8 | 21 | ||
| EG003 | Placebo | Placebo to Epanova and placebo to Dapagliflozin | 1 | 21 | 7 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Hydronephrosis | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stefan Carlsson | AstraZeneca | Stefan.C.Carlsson@astrazeneca.com |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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| >=50 - <65 |
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| >=65 |
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| Male |
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| White |
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