Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Diabetic Patients

PLx Pharma40 enrolled

Overview

This study will determine if aspirin from PL2200, an investigational product, gets into the blood stream as quickly as plain aspirin and enteric coated aspirin, and to test whether PL2200 is able to prevent blood clots as effectively as these other products, when administered to patients with diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

PL2200 Aspirin CapsulesDRUG

325 mg aspirin; once per day for 3 days

Immediate-Release Aspirin TabletsDRUG

325 mg aspirin; once per day for 3 days

Enteric-coated aspirin capletsDRUG

325 mg aspirin; once per day for 3 days

Eligibility

Sex: ALLMin age: 21 YearsMax age: 79 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults 21-79 * Body mass index (BMI) of 30-40 kg/m2 * Non-insulin-dependent type-2 diabetics (as confirmed by hemoglobin A1c (HbA1c) of \> 6.4% and/or fasting plasma glucose of \>125 mg/dL or current anti-diabetic medication) * AA-induced platelet aggregation response of \>60% within 3 hours prior to initial dose of study drug administration Exclusion Criteria: * Contraindications to aspirin * Previous history of vascular disease * Patient requires insulin * Use of non-steroidal anti-inflammatory drugs, anti-secretory agents, antacids, and salicylate-containing nutritional supplements within 2 weeks of randomization

Locations (1)

MedPace Clinical Pharmacology

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Time to 99% Inhibition of Serum Thromboxane (TxB2)

Aspirin's antiplatelet activity is measured by the capacity of platelets to generate serum thromboxane (a surrogate marker for inhibition of COX-1 by aspirin). Inhibition of serum thromboxane is a key marker of antiplatelet efficacy.

Time frame: 4 days

Data from ClinicalTrials.gov

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