Pemafibrate Randomized controlled study to Evaluate whether to reduce the risk of new onset of diabetes CompAred with diet therapy in patients with Under pre or early diabetic condiTION complicated with hypertriglyceridemia

JRCT ID: jRCTs031190139

Registered date:22/11/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Diabetes
• Date of first enrollment: 22/11/2019
• Target sample size: 20
• Study type: Interventional

Intervention(s)

Group A: In addition to dietary therapy for 12 weeks, oral administration of 0.2 mg pemafibrate in the morning and evening
Group B: 12week dietary therapy

Outcome(s)

• Primary Outcome: Change in blood glucose level AUC0-2h by 75g OGTT from baseline to 12 weeks (parallel group)

Secondary Outcome

- Changes of various parameters from baseline to the 12th week by 75g OGTT (before / after / parallel group)
- Changes of various parameters from baseline to the (4)12th week (before / after / parallel group)
- Percentage of transition from borderline to diabetic or normal, diabetic to borderline or normal
- Occurrence of adverse events and diseases

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

1. Fasting triglycerides over 150mg/dL and less than 500 mg / dL, or casual triglycerides over 200 mg / dL and less than 500 mg / dL (values for 12 weeks prior participation can be adopted)
2. Agreed to receive 75g OGTT
3. Aged 20-85 on day of signing informed consent
4. Patients who have received sufficient explanation for participation in this study, and who have fully understood the study plan and consented to the document by their own will

Exclude criteria

1. Currently receiving or are planning to receive diabetes agents
2. Treated with fibrate agents within 12 weeks prior to the study
3. Patients who have changed prescriptions for antihypertensive and dyslipidemia agents (including rotriga and epadale) within 12 weeks prior to the study
4. Patients who fall under a contraindication listed in the pemafibrate package insert
5. Patients with a history of malignant tumor or patients who are likely to relapse after remission
6. Patients who are determined to be inappropriate for this study by the principal investigator or research investigator

Related Information

• Primary Sponsor: Osamu Tomonaga
• Source(s) of Monetary Support: Kowa Company, Ltd.