Who is sponsoring NCT02305355?

NCT02305355 is sponsored by Kuhnil Pharmaceutical Co., Ltd..

What drugs are being tested in NCT02305355?

Interventions in NCT02305355: Omega-3-acids ethylesters 90 4g, Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin.

What condition does NCT02305355 study?

NCT02305355 studies Diabetes Mellitus, Type 2, Hypertriglycemia.

Is NCT02305355 still recruiting?

NCT02305355 is currently completed. Last updated 1 December 2014.

Last reviewed 2014-12-01 · How we verify

NCT02305355

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 4 Last updated 1 December 2014

What this trial tests

Phase 4 trial testing Omega-3-acids ethylesters 90 4g in Diabetes Mellitus, Type 2 in 68 participants. Completed in 1 February 2011.

Timeline

1 February 2009

Primary endpoint
1 February 2011

1 February 2011

Quick facts

Lead sponsor	Kuhnil Pharmaceutical Co., Ltd.
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	68
Start date	1 February 2009
Primary completion	1 February 2011
Estimated completion	1 February 2011
Sites	1 location across South Korea

Drugs / interventions tested

Omega-3-acids ethylesters 90 4g — full drug profile →
Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin — full drug profile →

Conditions studied

Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
Hypertriglycemia — all drugs for Hypertriglycemia →

Sponsor

Kuhnil Pharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 18 to 80, any sex, with Diabetes Mellitus, Type 2 or Hypertriglycemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

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.
Son JW, Kim CH, Nam MS, Park IB, et al · · 2019 · cited 2× · PMID 32821712 · DOI 10.12997/jla.2019.8.2.221

Verify or expand the search:

Other recruiting trials for Diabetes Mellitus, Type 2

Currently open trials in the same condition.

NCT07415954 — A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 · Phase 2 · recruiting
NCT07532863 — A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Part · recruiting
NCT07336329 — Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use · NA · recruiting
NCT07242469 — A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006) · Phase 1 · recruiting
NCT07444203 — Transformative Research in Diabetic Nephropathy 2.0 · recruiting

Other Kuhnil Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

NCT03482180 — Evaluate the Efficacy and Safety of KI1106 in Patients Whose TG Level is Not Adequately Controlled With Atorvastatin Cal · Phase 3 · completed
NCT01813253 — Phase 3 Study of Nimotuzumab and Irinotecan as Second Line With Advanced or Recurrect Gastric and Gastroesophageal Junct · Phase 3 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02305355 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Kuhnil Pharmaceutical Co., Ltd.
Last refreshed: 1 December 2014

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02305355.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing