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

PLx Pharma

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Enteric-coated aspirin caplets; Drug: Immediate-Release Aspirin Tablets; Drug: PL2200 Aspirin Capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT01515657

PL-ASA-004

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 21 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 3 patient groups

PL2200 Aspirin Capsules

Experimental group

Description:

Investigational drug arm; crossover design

Treatment:

Drug: PL2200 Aspirin Capsules

Immediate-Release Aspirin Tablets

Active Comparator group

Description:

Active comparator; crossover design

Treatment:

Drug: Immediate-Release Aspirin Tablets

Enteric-coated aspirin caplets

Active Comparator group

Description:

Active comparator; crossover design

Treatment:

Drug: Enteric-coated aspirin caplets