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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Enteric-coated aspirin caplets; Drug: PL2200 Aspirin Capsules

• Registration Number: NCT02008942
• Lead Sponsor: PLx Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-06
• Study First Submitted QC: 2013-12-06
• Study First Posted: 2013-12-11
• Study Start: 2014-01
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Results First Submitted: 2015-06-29
• Results First Submitted QC: 2015-08-05
• Results First Posted: 2015-09-04
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-09
• Last Update Posted: 2016-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Non-Insulin-Dependent Diabetes Mellitus
• Adults 21 to 79 years, inclusive
• Body mass index between 30 and 40 kg/m2, inclusive

Exclusion Criteria

• Currently prescribed aspirin or anti-coagulants
• Contraindications to aspirin
• Significant disease history or active disease other than Non-Insulin-Dependent Diabetes Mellitus
• Patient requires insulin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Enteric-coated aspirin caplets	Enteric-coated aspirin caplets	Enteric-coated aspirin caplets
PL2200 Aspirin Capsules	PL2200 Aspirin Capsules	PL2200 Aspirin Capsules

Primary Outcome Measures

Name	Time	Method
Time to 99% Inhibition of Serum Thromboxane	11 days	Serial measurements of aspirin anti-platelet activity will be collected over 11 days, and compared between groups, to allow a determination of pharmacodynamic (anti-platelet) bioequivalence between study drugs. 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.

Trial Locations

Locations (3)

Miami Research Associates; 🇺🇸 Miami, Florida, United States

Medpace Clinical Pharmacology; 🇺🇸 Cincinnati, Ohio, United States

PRA Clinical Pharmacology Center; 🇺🇸 Lenexa, Kansas, United States