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NCT Number: NCT01515657

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

MedPace Clinical Pharmacology

Cincinnati, Ohio, 45212, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PL2200 Aspirin Capsules

Drug

325 mg aspirin; once per day for 3 days

Immediate-Release Aspirin Tablets

Drug

325 mg aspirin; once per day for 3 days

Enteric-coated aspirin caplets

Drug

325 mg aspirin; once per day for 3 days

Primary outcomes

  1. Time to 99% Inhibition of Serum Thromboxane (TxB2)

    Time frame: 4 days

    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.

Sponsors and collaborators

Lead sponsor

PLx Pharma

Industry

Registry information

Official study title

A Randomized, Actively Controlled, Crossover Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Patients With Type II Diabetes

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 24, 2012
Registry last updated
Mar 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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