Phase 3
Completed N=40
Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Diabetic Patients
Source: ClinicalTrials.gov NCT01515657 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcomePrimary: Time to 99% Inhibition of Serum Thromboxane (TxB2) — 12.36; 16.65; 48.64 Hours
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to 99% Inhibition of Serum Thromboxane (TxB2) |
12.36; 16.65; 48.64 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01515657). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.