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

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ClinicalTrials.gov Identifier: NCT01515657

Recruitment Status : Completed

First Posted : January 24, 2012

Results First Posted : September 4, 2015

Last Update Posted : March 14, 2016

Sponsor:

Information provided by (Responsible Party):

PLx Pharma

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2	Drug: PL2200 Aspirin Capsules Drug: Immediate-Release Aspirin Tablets Drug: Enteric-coated aspirin caplets	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	A Randomized, Actively Controlled, Crossover Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Patients With Type II Diabetes
Study Start Date :	January 2012
Actual Primary Completion Date :	June 2012
Actual Study Completion Date :	June 2012

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Type 2 diabetes

Drug Information available for: Aspirin

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: PL2200 Aspirin Capsules Investigational drug arm; crossover design	Drug: PL2200 Aspirin Capsules 325 mg aspirin; once per day for 3 days
Active Comparator: Immediate-Release Aspirin Tablets Active comparator; crossover design	Drug: Immediate-Release Aspirin Tablets 325 mg aspirin; once per day for 3 days
Active Comparator: Enteric-coated aspirin caplets Active comparator; crossover design	Drug: Enteric-coated aspirin caplets 325 mg aspirin; once per day for 3 days

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

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Ages Eligible for Study:	21 Years to 79 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01515657

Locations

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United States, Ohio
MedPace Clinical Pharmacology
Cincinnati, Ohio, United States, 45212

Sponsors and Collaborators

PLx Pharma

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bhatt DL, Grosser T, Dong JF, Logan D, Jeske W, Angiolillo DJ, Frelinger AL 3rd, Lei L, Liang J, Moore JE, Cryer B, Marathi U. Enteric Coating and Aspirin Nonresponsiveness in Patients With Type 2 Diabetes Mellitus. J Am Coll Cardiol. 2017 Feb 14;69(6):603-612. doi: 10.1016/j.jacc.2016.11.050. Epub 2017 Jan 11.

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Responsible Party:	PLx Pharma
ClinicalTrials.gov Identifier:	NCT01515657
Other Study ID Numbers:	PL-ASA-004
First Posted:	January 24, 2012 Key Record Dates
Results First Posted:	September 4, 2015
Last Update Posted:	March 14, 2016
Last Verified:	February 2016

Additional relevant MeSH terms:

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Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents	Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics

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