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

Phase 3

Completed

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

• Registration Number: NCT01515657
• 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-13
• Study First Submitted QC: 2012-01-18
• Study First Posted: 2012-01-24
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2015-06-22
• Results First Submitted QC: 2015-08-05
• Results First Posted: 2015-09-04
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-11
• Last Update Posted: 2016-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Immediate-Release Aspirin Tablets	Immediate-Release Aspirin Tablets	Active comparator; crossover design
Enteric-coated aspirin caplets	Enteric-coated aspirin caplets	Active comparator; crossover design
PL2200 Aspirin Capsules	PL2200 Aspirin Capsules	Investigational drug arm; crossover design

Primary Outcome Measures

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

Trial Locations

Locations (1)

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