Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Diabetic Patients
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 21 - 79 |
| Updated: | 4/21/2016 |
| Start Date: | January 2012 |
| End Date: | June 2012 |
A Randomized, Actively Controlled, Crossover Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Patients With Type II Diabetes
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.
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.
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
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