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

December 1, 2014 updated by: Kuhnil Pharmaceutical Co., Ltd.
Assess efficacy and safety of Omacor® 4g with statin treatment for lowering TG levels in subjects with type 2 Diabetes combined with hyperlipidemia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omega-3-acids ethylesters 90 4g, any statin
Drug: Omega-3-acids ethylesters 90 4g
Other Names:
  • Omacor Soft Capsule 4g
Drug: Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin
Active Comparator: any statin
Drug: Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The mean percent change of Triglyceride(TG)
Time Frame: from baseline at week 16
from baseline at week 16

Secondary Outcome Measures

Outcome Measure
Time Frame
The mean percent change of Total Cholesterol(TC)
Time Frame: from baseline at week 16
from baseline at week 16
The mean percent change of LDL-C
Time Frame: from baseline at week 16
from baseline at week 16
The mean percent change of HDL-C
Time Frame: from baseline at week 16
from baseline at week 16
The mean percent change of HBA1c
Time Frame: from baseline at week 16
from baseline at week 16
The mean percent change of FPG
Time Frame: from baseline at week 16
from baseline at week 16
The mean percent change of hs-CRP
Time Frame: from baseline at week 16
from baseline at week 16
The mean percent change of PAI-1
Time Frame: from baseline at week 16
from baseline at week 16
The mean percent change of Apolipoprotein A1
Time Frame: from baseline at week 16
from baseline at week 16
The mean percent change of apolipoprotein B
Time Frame: from baseline at week 16
from baseline at week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuhnil Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

November 25, 2014

First Submitted That Met QC Criteria

December 1, 2014

First Posted (Estimate)

December 2, 2014

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-OM-9412

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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