Compared effects of ezetimibe and omega-3-acid ethyl esters on lipid metabolism in type 2 diabetic patients with hypercholesterolemia

Compared effects of ezetimibe and omega-3-acid ethyl esters on lipid metabolism in type 2 diabetic patients with hypercholesterolemia - Ezetimibe and omega-3-acid ethyl esters study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025175

Enrollment

Registered

2016-12-07

Start date

2015-03-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-risk Hypercholesterolemia

Interventions

Current statin + Ezetimibe 10 mg/day Current strong statin + omega-3 acid ethyl esters 2 g/day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. LDL-C>=120mg\ or nonHDL-C>=150mg/dL 2. Type 2 diabetes mellitus 3. Using statin 4. Adult (Age>=20years old) 5. No alternation of lipid lowering/oral diabetic agents within 12 weeks.

Exclusion criteria

Exclusion criteria: 1. Currently treated with EPA or study drugs 2. Treated with insulin 3. Hypersensitivity with study drugs 4. Severe liver dysfunction (AST or ALT >=100 IU) 5. History of cerebro/cardiovascular disease 6. Secondary hyperlipidemia 7. Pregnant, brestfeeding or risk of pregnant woman 8. Familial hypercholesterolemia 9. Patients inappropriate for the trial judged by investigators

Design outcomes

Primary

Measure	Time frame
Change of non HDL-Cholesterol between two arms at week 12.	—

Secondary

Measure	Time frame
Change in all measurments (TC, HLD-C, LDL-C, RLP-C, sLDL-C, MDA-LDL, TG, ApoB-48, ApoB-100, Campesterol, Sitosterol, Lathosterol, AGEs, FBS, HOMA-IR, BUN, Creatinin, Urinary albumin, Urinary creatinin, hsCRP, Adiponectin, ICAM-1, VCAM-1, RAGE, ADMA) at week 12.	—

Countries

Japan

Contacts

Public ContactYosuke Nakayama

Kurume University School of Medicine Division of Nephrology, Department of Medicine, Kurume University School of Medicine

nakayama_yosuke@med.kurume-u.ac.jp0942-35-3311

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026