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AzTrials

Diabetes Mellitus, Type 2Phase 4NCT02305355

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

A Phase 4 study testing Omega-3-acids ethylesters 90 4g and Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin in people with Diabetes Mellitus, Type 2 and Hypertriglycemia, run by Kuhnil Pharmaceutical Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetes Mellitus, Type 2, Hypertriglycemia
What is being tested?
Omega-3-acids ethylesters 90 4g and Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteSouth Korea
Study dates
Feb 2009to Feb 2011
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Bucheon St. Mary's Hospital

    Bucheon-si

Other trials in South Korea

About this study

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

Being tested
Omega-3-acids ethylesters 90 4g, Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omega-3-acids ethylesters 90 4gDrug

    Also called Omacor Soft Capsule 4g

  • Pravastatin, Simvastatin, Atorvastatin, RosuvastatinDrug

Study groups in NCT02305355
Study groupRoleWhat they receive
Omega-3-acids ethylesters 90 4g, any statinExperimentalNot described
Receives: Drug: Omega-3-acids ethylesters 90 4g; Drug: Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin
any statinActive comparatorNot described
Receives: Drug: Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The mean percent change of Triglyceride(TG)

    Measured: from baseline at week 16

Secondary outcomes (9)

  1. The mean percent change of Total Cholesterol(TC)

    Measured: from baseline at week 16

  2. The mean percent change of LDL-C

    Measured: from baseline at week 16

  3. The mean percent change of HDL-C

    Measured: from baseline at week 16

  4. The mean percent change of HBA1c

    Measured: from baseline at week 16

  5. The mean percent change of FPG

    Measured: from baseline at week 16

  6. The mean percent change of hs-CRP

    Measured: from baseline at week 16

  7. The mean percent change of PAI-1

    Measured: from baseline at week 16

  8. The mean percent change of Apolipoprotein A1

    Measured: from baseline at week 16

  9. The mean percent change of apolipoprotein B

    Measured: from baseline at week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2014 (estimated)
  2. Study startFeb 2009
  3. Primary completionFeb 2011
  4. Study completionFeb 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02305355
Sponsor's protocol ID
08-OM-9412
Status last verified
Nov 2014
First submitted
25 Nov 2014
Last updated
2 Dec 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 32821712

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Omega-3-acids ethylesters 90 4g and Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin in people with Diabetes Mellitus, Type 2 and Hypertriglycemia, run by Kuhnil Pharmaceutical Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The mean percent change of Triglyceride(TG) (time frame: from baseline at week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02305355, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.

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