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

Kuhnil Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Hypertriglycemia; Diabetes Mellitus, Type 2

Treatments: Drug: Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin; Drug: Omega-3-acids ethylesters 90 4g

Study type: Interventional

Funder types: Industry

Identifiers

NCT02305355

08-OM-9412

Details and patient eligibility

About

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

Enrollment: 68 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Omega-3-acids ethylesters 90 4g, any statin

Experimental group

Treatment:

Drug: Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin

Drug: Omega-3-acids ethylesters 90 4g

any statin

Active Comparator group

Treatment:

Drug: Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin