PARADISE in Kagoshima study

JRCT ID: jRCTs071190049

Registered date:06/03/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: hyperlipidemia, Type 2 Diabetes Mellitus
• Date of first enrollment: 15/04/2020
• Target sample size: 100
• Study type: Interventional

Intervention(s)

Study subjects are assigned into following two groups, and study agent or control agent is administered for 16 weeks.
Group A: pemafibrate
Group B: ethyl icosapentate

Outcome(s)

• Primary Outcome: Change in FMD from baseline to week 16

Secondary Outcome

1.Change in following biomarkers from baseline to week 16
2.Correlation between the change in FMD and the change in the biomarkers above from baseline to week 16
3.Change in CVR-R from baseline to week 16
4.Information of adverse events or disease or the like

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

Patients who meet all of the following criteria are included in this study:
1.Patients with hyperlipidemia whose casual triglyceride is 175 mg/dL or higher, and 1000 mg/dL or lower, or whose fasting triglyceride is 150 mg/dL or higher, and 1000 mg/dL or lower.
2.Patients who are diagnosed as type 2 diabetes mellitus, and whose carbohydrate metabolism is stable (difference in HbA1c of the latest two measures are less than 1%)
3.Male and female aged 20 years or older, and younger than 80 years when giving their consent
4.Patients who give their consent in a written form

Exclude criteria

Patients who fall into any of the following criteria are excluded from participating in the study:
1.Patients with type 1 diabetes mellitus
2.Patients with unstable glycemic control (HbA1c in the latest 12 weeks is 9% or higher)
3.Patients with renal impairment (serum creatinine is 1.5 mg/dL or higher)
4.Patients with history of hypersensitivity against the study agent or the control agent, or who meet contraindication for the study agent or the control agent
5.Patients who used fibrate within 4 weeks before giving their consent
6.Patients who used omega-3 fatty acid or any supplements with same effect within 12 weeks before giving their consent
7.Patients who used corticosteroid such as prednisolone within 12 weeks before giving their consent.
Patients who used corticosteroid of 10mg/day or less, and whose disease status is stable, can be included.
8.Patients who changed the usage or dose of hydroxymethylglutaryl-CoA reductase inhibitor or angiotensin receptor antagonist within 4 weeks before giving their consent
9.Patients with cancer or who are treated with anticancer agent
10.Patients with hemorrhage or hemorrhagic diathesis
11.Patients with familial hypercholesterolemia
12.Patients who are breastfeeding, pregnant, or possibly pregnant
13.Patients who are participating in other interventional trials
14.Patients with other conditions that the investigator or researcher thinks inappropriate for the study

Related Information

• Primary Sponsor: Nishio Yoshihiko
• Secondary Sponsor: Soiken Inc.