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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PLx Pharma
• Treatments: Aspirin

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