The Effects of Omega-3 Fatty Acid (OMACOR) on the Low-density Lipoprotein (LDL) Sub-fraction in Type 2 Diabetic Patients

• Status: Unknown status
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to verify the possible effects of OMACOR(omega-3 fatty acid) on the percentage change of small dense LDL fraction in type 2 diabetic patients with combined hyperlipidemia, we perform open-label prospective randomized multi-institutional phase IV study.

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

Details

• Lead Sponsor: Inje University
• Collaborator: Kuhnil Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

• Agreed for informed consent

• Age between 40-70 years old

• Type 2 diabetes mellitus

• Combined hyperlipidemia

• Serum triglyceride level between 200-500(mg/dl)

• No sudden change of glucose lowering therapies during trial, anticipated

Exclusion Criteria:

• Hypersensitivity to OMACOR(Omega-3 fatty acid)

• Alcoholics

• Pregnancy

• Proliferative diabetic retinopathy

• Patients already taking fibrates

• Enrolled in other clinical trials during the recent 3 months

• Severe ischemic heart disease, liver disease, neurological disease

• AST/ALT level 2 folds above the normal reference level

• Psychiatric disorder not adequately controlled

• Serum creatinine over 2.0 (mg/dl)

• Previous pancreatic surgery

• Patients who can not maintain regular diet