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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

Primary Purpose

Diabetes Mellitus, Type 2, Hypertriglycemia

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Omega-3-acids ethylesters 90 4g
Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin
Sponsored by
Kuhnil Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Bucheon St. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

any statin

Arm Description

Outcomes

Primary Outcome Measures

The mean percent change of Triglyceride(TG)

Secondary Outcome Measures

The mean percent change of Total Cholesterol(TC)
The mean percent change of LDL-C
The mean percent change of HDL-C
The mean percent change of HBA1c
The mean percent change of FPG
The mean percent change of hs-CRP
The mean percent change of PAI-1
The mean percent change of Apolipoprotein A1
The mean percent change of apolipoprotein B

Full Information

First Posted
November 25, 2014
Last Updated
December 1, 2014
Sponsor
Kuhnil Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02305355
Brief Title
Efficacy and Safety of Prescription Omega-3 Fatty Acid Added to Stable Statin Therapy in Patients With Type 2 Diabetes and Hypertriglyceridemia
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 Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuhnil Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Hypertriglycemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omega-3-acids ethylesters 90 4g, any statin
Arm Type
Experimental
Arm Title
any statin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Omega-3-acids ethylesters 90 4g
Other Intervention Name(s)
Omacor Soft Capsule 4g
Intervention Type
Drug
Intervention Name(s)
Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin
Primary Outcome Measure Information:
Title
The mean percent change of Triglyceride(TG)
Time Frame
from baseline at week 16
Secondary Outcome Measure Information:
Title
The mean percent change of Total Cholesterol(TC)
Time Frame
from baseline at week 16
Title
The mean percent change of LDL-C
Time Frame
from baseline at week 16
Title
The mean percent change of HDL-C
Time Frame
from baseline at week 16
Title
The mean percent change of HBA1c
Time Frame
from baseline at week 16
Title
The mean percent change of FPG
Time Frame
from baseline at week 16
Title
The mean percent change of hs-CRP
Time Frame
from baseline at week 16
Title
The mean percent change of PAI-1
Time Frame
from baseline at week 16
Title
The mean percent change of Apolipoprotein A1
Time Frame
from baseline at week 16
Title
The mean percent change of apolipoprotein B
Time Frame
from baseline at week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Bucheon St. Mary's Hospital
City
Bucheon
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
32821712
Citation
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.
Results Reference
derived

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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

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