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

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT01515657

Run by

PLx Pharma

People needed

40

Starts

2012-01-01

Expected to finish

2012-06-01

Last updated by the study team

2016-03-14

Who can join

Age: 21 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• MedPace Clinical Pharmacology — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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