Pemafibrate to reduce heart problems by reducing the fats in blood of patients with diabetes

Phase 3

• Conditions: Health Condition 1: null- Cardiovascular disease risk in patients with diabetes and high triglycerides and low HDL-CHealth Condition 2: I999- Unspecified disorder of circulatory system

• Registration Number: CTRI/2017/07/009172
• Lead Sponsor: Kowa Research Institute Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 0

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;

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified