T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin) Clinical Trial
— EFFECTIIOfficial 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
Verified date | January 2016 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Medical Products Agency |
Study type | Interventional |
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))
Status | Completed |
Enrollment | 223 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 75 Years |
Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Research Site | Göteborg | |
Sweden | Research Site | Linkoping | |
Sweden | Research Site | Örebro | |
Sweden | Research Site | Stockholm | |
Sweden | Research Site | Uppsala |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca | Uppsala Clinical Research, Uppsala, Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline to week 12 in the % liver fat content as measured by MRI. | 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. | 12 weeks | No |
Secondary | Change from baseline to week 12 in the % liver fat content as measured by MRI. | 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. | 12 weeks | No |