Health Condition 1: null- Cardiovascular disease risk in patients with diabetes and high triglycerides and low HDL-C Health Condition 2: I999- Unspecified disorder of circulatory system
Conditions
Interventions
Intervention1: K-877 (pemafibrate) 0.2 mg: Dose: 1 tablet twice daily
Mode of Administration: Oral
Control Intervention1: Matching placebo tablet (placebo) 0 mg: Dose: 1 tablet twice daily
Mode of Ad
Sponsors
Kowa Research Institute Inc
Ms IQVIA RDS India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Fasting TG � 200 mg/dL (2.26 mmol/L) and (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; a) Age � 50 years if male or � 55 years if female (primary prevention cohort), OR b) 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 [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
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-�³ 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective of the study is to determine whether pemafibrate administered at a dose of 0.2 mg twice daily will delay the time to first occurrence of any component of the clinical composite endpoint of:Timepoint: - Nonfatal myocardial infarction (MI); - Nonfatal ischemic stroke; - Hospitalization for unstable angina requiring unplanned coronary revascularization; or - Cardiovascular (CV) death | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary scientific aim of this study is to investigate 1) the efficacy (time to first occurrence) of a number of secondary CV and diabetes-related vascular and nonvascular endpoints in the study population, and 2) the efficacy (as measured by the percent change from baseline) for a number of lipid measures.Timepoint: from time to first occurrence and as measured by the percent change from baseline | — |
Countries
Argentina, Brazil, Bulgaria, Canada, Colombia, Czech Republic, Denmark, France, Germany, Hungary, India, Israel, Japan, Mexico, Netherlands, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Ukraine, United Kingdom, United States of America
Contacts
Public ContactSuneela Thatte
IQVIA RDS (India) Private Limited
Outcome results
None listed