NCT02305355

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Feb 2009

Typical duration for phase_4 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 2, 2014

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

2 years

First QC Date

November 25, 2014

Last Update Submit

December 1, 2014

Conditions

Diabetes Mellitus, Type 2Hypertriglycemia

Outcome Measures

Primary Outcomes (1)

  • The mean percent change of Triglyceride(TG)

    from baseline at week 16

Secondary Outcomes (9)

  • The mean percent change of Total Cholesterol(TC)

    from baseline at week 16

  • 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

  • +4 more secondary outcomes

Study Arms (2)

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

EXPERIMENTAL
Drug: Omega-3-acids ethylesters 90 4gDrug: Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin

any statin

ACTIVE COMPARATOR
Drug: Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin

Interventions

Omega-3-acids ethylesters 90 4gDRUG
Also known as: Omacor Soft Capsule 4g
Omega-3-acids ethylesters 90 4g, any statin
Pravastatin, Simvastatin, Atorvastatin, RosuvastatinDRUG
Omega-3-acids ethylesters 90 4g, any statinany statin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bucheon St. Mary's Hospital

Bucheon-si, South Korea

Location

Related Publications (1)

  • Son JW, Kim CH, Nam MS, Park IB, Yoo SJ. Efficacy and Safety of Prescription Omega-3 Fatty Acids Added to Stable Statin Therapy in Korean Patients with Type 2 Diabetes and Hypertriglyceridemia: a Randomized Controlled Trial. J Lipid Atheroscler. 2019 Sep;8(2):221-231. doi: 10.12997/jla.2019.8.2.221. Epub 2019 Jul 4.

    PMID: 32821712DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

PravastatinSimvastatinAtorvastatinRosuvastatin Calcium

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsLovastatinPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsSulfonamidesAmidesFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedSulfonesSulfur CompoundsPyrimidines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2014

First Posted

December 2, 2014

Study Start

February 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations

KR(1)