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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2; Hypertriglycemia
• Interventions: Drug: Omega-3-acids ethylesters 90 4g; Drug: Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin

• Registration Number: NCT02305355
• Lead Sponsor: Kuhnil Pharmaceutical Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2014-11
• Study First Submitted: 2014-11-25
• Study First Submitted QC: 2014-12-01
• Last Update Submitted: 2014-12-01
• Study First Posted: 2014-12-02
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omega-3-acids ethylesters 90 4g, any statin	Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin	-
Omega-3-acids ethylesters 90 4g, any statin	Omega-3-acids ethylesters 90 4g	-
any statin	Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin	-

Primary Outcome Measures

Name	Time	Method
The mean percent change of Triglyceride(TG)	from baseline at week 16

Secondary Outcome Measures

Name	Time	Method
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 hs-CRP	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 Total Cholesterol(TC)	from baseline at week 16

Trial Locations

Locations (1)

Bucheon St. Mary's Hospital; 🇰🇷 Bucheon, Korea, Republic of