PROMINENT Pemafibrate to Reduce cardiovascular OutcoMes by reducing triglycerides IN patiENts with diabeTes

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Diabetes
  • Age: Between 0 - 55 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects with fasting triglycerides (TGs)= 200 mg/dL (2.26 mmol/L) and < 500 mg/dL (5.65 mmol/L) at Visit 1
    2. Subject with high-density lipoprotein cholesterol (HDL-C) = 40 mg/dL (1.03 mmol/L) at Visit 1
    3. Subjects with Type 2 diabetes of longer than 12 weeks duration documented in medical records
    4. Subjects who have been receiving treatment with a stable dose of a qualifying moderate to high intensity statin or have evidence of LDL-C = 70 mg/dL or statin intolerant and have evidence of LDL-C= 100 mg/dL
    5. Subjects with the ability to understand and comply with study procedures and give written informed consent.

You may not be eligible for this study if the following are true:

    1. Subjects who are currently or planned use of fibrates or agents with potent peroxisome proliferator activated receptor (PPAR)-a agonist activity (eg, saroglitazar) within 6 weeks (42 days) of Visit 1
    2. Subjects with known sensitivity to PPAR-a agonists or tablet excipients
    3. Initiation of, or change in, current TG-lowering therapy within 12 weeks of Visit 1
    4. Subjects with Type 1 diabetes mellitus
    5. Subjects with uncontrolled diabetes mellitus as defined by a HbA1c > 9.5%
    6. Untreated or inadequately treated hypothyroidism
    7. Subjects with recent CVD event within 8 weeks of Visit 2
    8. Subjects with recent or planned vascular intervention within 8 weeks of Visit 2
    9. Subjects who has New York Heart Association Class IV heart failure (HF)
    10. Subjects with known homozygous familial hypercholesterolemia
    11. Subjects with documented previous occurrence of myositis/myopathy
    12. Subjects with biliary obstruction or hyperbilirubinemia
    13. Subjects with liver disease
    14. Subjects with chronic renal insufficiency
    15. Subjects with unexplained anemia
    16. Subjects with uncontrolled hypertension
    17. History of chronic active hepatitis B or hepatitis C, or known infection with human immunodeficiency virus
    18. Subjects who have active malignancy
    19. Prior organ transplant or any condition likely to lead to organ transplantation in the next 5 years
    20. Current or anticipated chronic use of cyclosporine, rifampicin, or other inhibitors of organic anion transporting polypeptides (OATP)1B1, or OATP1B3
    21. History of alcoholism or unwillingness to limit alcohol intake
    22. History of hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
    23. Subjects are pregnant, lactating, planning to be pregnant or lactating udring the study period
    24. A medical condition, other than vascular disease, with life expectancy <3 years
    25. Subjects with any factors which will limit participation in the study



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