Last updated on March 2020

Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT)

Are you eligible to participate in this study?

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

  • Conditions: Dyslipidemia | Type2 Diabetes
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Fasting TG 200 mg/dL (2.26 mmol/L) and < 500 mg/dL (5.65 mmol/L) at Visit 1 (Screening/Enrollment Visit) or Visit 1.1 (Retest)
  2. HDL-C 40 mg/dL (1.03 mmol/L) at Visit 1 (Screening/Enrollment Visit) or Visit 1.1 (Retest)
  3. Type 2 diabetes of longer than 12 weeks duration documented in medical records, for example: local laboratory evidence through medical record review of elevated HbA1c ( 6.5% [48 mmol/mol]), elevated plasma glucose (fasting 126 mg/dL [7.0 mmol/L], 2-hour 200 mg/dL [11.1 mmol/L] during oral glucose tolerance testing, or random value 200 mg/dL with classic symptoms, or currently taking medication for treatment of diabetes; AND either
  4. Age 50 years if male or 55 years if female (primary prevention cohort); OR
  5. Age 18 years and established systemic atherosclerosis (secondary prevention cohort), defined as any 1 of the following:
    • i. Prior MI or ischemic (non-hemorrhagic) stroke
    • ii. Coronary angiographic lesion of 60% stenosis in a major epicardial vessel or 50% left main stenosis
    • iii. Asymptomatic carotid disease with 70% carotid artery stenosis
    • iv. Symptomatic carotid disease with 50% carotid artery stenosis
    • v. Symptomatic lower extremity PAD (ie, intermittent claudication, rest pain, lower extremity ischemic ulceration, or major amputation with either ankle-brachial index 0.9 or other diagnostic testing [eg, toe-brachial index, angiogram, or other imaging study])
    • vi. Prior arterial revascularization procedure (including coronary, carotid, or peripheral angioplasty/stenting, bypass, or atherectomy/endarterectomy)

Exclusion Criteria:

  1. Current or planned use of fibrates or agents with PPAR- agonist activity (eg, saroglitazar) within 6 weeks (42 days) of Visit 1 (Screening/Enrollment Visit). Note: PPAR- agonists (eg, glizatones such as pioglitazone and rosiglitazone) are allowed
  2. Known sensitivity to PPAR- agonists or tablet excipients
  3. Initiation of, or change in, current TG-lowering therapy within 12 weeks of Visit 1 (if applicable). Note: TG-lowering therapy is defined as niacin > 100 mg/day or dietary supplements or prescription omega-3 fatty acids > 1 g/day
  4. Type 1 diabetes mellitus

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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