Type 2 diabetes
Conditions
Interventions
statin + EPA group (Group SE)
Clinical investigators will initiate EPA (1800 mg/day) treatment in those who were already receiving simvastatin (5-20 mg/day) or pravastatin (5-20 mg/day). Treatment will be continued to achieve the
Clinical investigators will continue simvastatin (5-20 mg/day) or pravastatin (5-20 mg/day) treatment following the allocation in the statin mono-therapy group. Treatment will be continued to achieve
Sponsors
Osaka University Graduate School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) dyslipidemic type 2 diabetic patients treated with pravastatin or simvastatin 2) Aged 20 to 80 years of age at the time of enrollment (regardless of gender) 3) Written consent for participation in the study
Exclusion criteria
Exclusion criteria: Patients meeting one of the following conditions will be excluded: 1) type 1 and secondary diabetes, 2) severe infectious disease, before or after surgery, and severe trauma, 3) events of myocardial infarction, angina pectoris, cerebral stroke, and cerebral infarction, 4) moderate or severe renal dysfunction (serum creatinine (mg/dL): male, 1.4<; female, 1.2<), 5) severe liver dysfunction (AST: 100 IU/l or higher), 6) moderate or severe heart failure) (NYHA/New York Heart Association stage III or severer), 7) under treatment with an EPA preparation at the time of study initiation, 8) pregnant, lactating, and possibly pregnant women and those planning to become pregnant, 9) patients with bleeding (hemophilia, gastrointestinal ulceration, urinary tract bleeding, hemoptysis, vitreous hemorrhage, etc.), 10) past medical history of hypersensitivity to investigational drugs, 11) judged as ineligible by clinical investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the calibrated-IBS value measured at the thickest site of the carotid artery during a 12-months treatment period | — |
Countries
Japan
Contacts
Public ContactNaoto Katakami
Osaka University Graduate School of Medicine Department of Metabolic Medicine
Outcome results
None listed