Efficacy and Safety of Prescription Omega-3 Fatty Acid Added to Stable Statin Therapy in Patients With Type 2 Diabetes and Hypertriglyceridemia

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Assess efficacy and safety of Omacor® 4g with statin treatment for lowering TG levels in subjects with type 2 Diabetes combined with hyperlipidemia

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kuhnil Pharmaceutical Co., Ltd.
• Treatments: Atorvastatin; Atorvastatin Calcium; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Pravastatin; Rosuvastatin Calcium; Simvastatin

Criteria

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