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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02305355
Recruitment Status : Completed
First Posted : December 2, 2014
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Hypertriglycemia Drug: Omega-3-acids ethylesters 90 4g Drug: Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Prescription Omega-3 Fatty Acid Added to Stable Statin Therapy in Patients With Type 2 Diabetes and Hypertriglyceridemia
Study Start Date : February 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011


Arm Intervention/treatment
Experimental: Omega-3-acids ethylesters 90 4g, any statin Drug: Omega-3-acids ethylesters 90 4g
Other Name: Omacor Soft Capsule 4g

Drug: Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin
Active Comparator: any statin Drug: Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin



Primary Outcome Measures :
  1. The mean percent change of Triglyceride(TG) [ Time Frame: from baseline at week 16 ]

Secondary Outcome Measures :
  1. The mean percent change of Total Cholesterol(TC) [ Time Frame: from baseline at week 16 ]
  2. The mean percent change of LDL-C [ Time Frame: from baseline at week 16 ]
  3. The mean percent change of HDL-C [ Time Frame: from baseline at week 16 ]
  4. The mean percent change of HBA1c [ Time Frame: from baseline at week 16 ]
  5. The mean percent change of FPG [ Time Frame: from baseline at week 16 ]
  6. The mean percent change of hs-CRP [ Time Frame: from baseline at week 16 ]
  7. The mean percent change of PAI-1 [ Time Frame: from baseline at week 16 ]
  8. The mean percent change of Apolipoprotein A1 [ Time Frame: from baseline at week 16 ]
  9. The mean percent change of apolipoprotein B [ Time Frame: from baseline at week 16 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02305355


Locations
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Korea, Republic of
Bucheon St. Mary's Hospital
Bucheon, Korea, Republic of
Sponsors and Collaborators
Kuhnil Pharmaceutical Co., Ltd.

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Responsible Party: Kuhnil Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02305355    
Other Study ID Numbers: 08-OM-9412
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertriglyceridemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Atorvastatin
Rosuvastatin Calcium
Simvastatin
Pravastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors