Effect of addition of pemafibrate and double dose of statin on small dense LDL cholesterol in statin-treated patients with type 2 diabetes and hypertriglyceridemia: A comparative Study.

JRCT ID: jRCTs031190232

Registered date:28/02/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hypertriglyceridemia
• Date of first enrollment: 28/02/2020
• Target sample size: 102
• Study type: Interventional
• Intervention(s): After obtaining informed consent, patients with type 2 diabetes occurring with hypertriglyceridemia who have been taking statin for 3 months or more are randomly allocated to either group receiving pemafibrate 0.2 mg/day in addition to statin or group receiving doubling dose of statin. The patients are followed for 12 weeks.

Outcome(s)

• Primary Outcome: sd LDL-C reduction rate

Secondary Outcome

Absolute concentration and reduction rate of each item
1. sd LDL-C(Absolute concentration onlys)
2. Large LDL-C
3. LDL-C
4. HDL fractionation
5. sd LDL-C / Large LDL-C
6. LDL-TG, LDL-TG/LDL-C
7. TG, HDL-C
8. Non-HDL-C
9. RLP-C
10. Toxic-AGEs
11. VLDL-C (a formula)
12. ANGPTL2, ANGPTL3, ANGPTL4, ANGPTL8
13. Apo A1, Apo A2, Apo B, Apo CII, Apo CIII, Apo E
14. High sensitivity CRP
15. AST, ALT, gamma-GTP, ALP, CK, Creatinine
16. Blood sugar, insulin, HOMA-IR
17. eGFR
18. FIB-4 index
19. Cholinesterase
20. HbA1c, Glycoalbumin
21. HbA1c/Glycoalbumin
22. Urine Albumin-to-Creatinine Ratio

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Age>=20 years old
2. Type 2 diabetes patients
3. Patients who have been taking below statins for 3 months or longer without changing
Atorvastatin 5, 10 mg/day
Pitavastatin 1, 2 mg/day
Rosuvastatin 2.5 mg/day
4. 150mg/dL=<TG<500mg/dL within three months prior to informed consent
5. Written informed consent

Exclude criteria

1. Type 1 diabetes patients
2. 160mg/dL=<LDL-C<70mg/dL within three months prior to informed consent
3. Patients taking cyclosporine, rifampicin, PCSK9 inhibitors, MTP inhibitors
4. HbA1c>=10% within three months prior to informed consent
5. familial hypercholesteremia
6. Patients taking statins other than those specified in the inclusion criteria
7. Patients taking statins other than those prescribed by the inclusion criteria
8. Patients who have taken SPPARM alpha or fibrates within three months prior to informed consent
9. Patients who have changed prescriptions for dyslipidemia * and diabetes <*Ezetimibe (including compounding agents), anion exchange resin, ethyl icosapentate (including supplements), ethyl omega-3 fatty acid (including supplements)> within three months prior to informed consent
10. Patients receiving pemafibrate
11. 1.5mg/dL=<serum creatinine
12. Alcoholics patients (or alcohol abuse patients)
13. Patients who have developed diabetic ketoacidosis within three months prior to informed consent
14. Patients with active malignant tumor, autoimmune disease, infectious disease
15. Any other patients regarded unsuitable by the principal investigator or sub-investigators

Related Information

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