Status:
COMPLETED
Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Diabetic Patients
Lead Sponsor:
PLx Pharma
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
21-79 years
Phase:
PHASE3
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01515657
Start Date
January 1 2012
End Date
June 1 2012
Last Update
March 14 2016
Active Locations (1)
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1
MedPace Clinical Pharmacology
Cincinnati, Ohio, United States, 45212