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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01515657
• Other study ID #: PL-ASA-004
• Status: Completed
• Phase: Phase 3
• First received: January 13, 2012
• Last updated: February 11, 2016
• Start date: January 2012
• Est. completion date: June 2012

Study information

• Verified date: February 2016
• Source: PLx Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 79 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• PL2200 Aspirin Capsules
325 mg aspirin; once per day for 3 days
• Immediate-Release Aspirin Tablets
325 mg aspirin; once per day for 3 days
• Enteric-coated aspirin caplets
325 mg aspirin; once per day for 3 days

Locations

Country	Name	City	State
United States	MedPace Clinical Pharmacology	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
PLx Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 days	No