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Completed

NCT Number: NCT02305355

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

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypertriglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bucheon St. Mary's Hospital

Bucheon-si, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3-acids ethylesters 90 4g

Drug

Other names: Omacor Soft Capsule 4g

Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin

Drug

Primary outcomes

  1. The mean percent change of Triglyceride(TG)

    Time frame: from baseline at week 16

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Kuhnil Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 2, 2014
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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