Diabetes Mellitus, Type 2, Hypertriglycemia
Conditions
Brief summary
Assess efficacy and safety of Omacor® 4g with statin treatment for lowering TG levels in subjects with type 2 Diabetes combined with hyperlipidemia
Interventions
DRUGPravastatin, Simvastatin, Atorvastatin, Rosuvastatin
Sponsors
Kuhnil Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* LDL-C \< 100mg/dL, TG \> 150mg/dL, patients on statin treatment for at least 6 weeks prior to randomization. * Type 2 Diabetes * HbA1c ≤ 10.0
Exclusion criteria
* Type 1 Diabetes * Patients with PPAR gamma agonist therapy * Patients with acute MI, Unstable angina within 6 months * History of malignant tumor within 2 years * Women with pregnant, breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean percent change of Triglyceride(TG) | from baseline at week 16 |
Secondary
| Measure | Time frame |
|---|---|
| The mean percent change of LDL-C | from baseline at week 16 |
| The mean percent change of HDL-C | from baseline at week 16 |
| The mean percent change of HBA1c | from baseline at week 16 |
| The mean percent change of FPG | from baseline at week 16 |
| The mean percent change of Total Cholesterol(TC) | from baseline at week 16 |
| The mean percent change of PAI-1 | from baseline at week 16 |
| The mean percent change of Apolipoprotein A1 | from baseline at week 16 |
| The mean percent change of apolipoprotein B | from baseline at week 16 |
| The mean percent change of hs-CRP | from baseline at week 16 |
Countries
South Korea
Outcome results
None listed