Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated Aspirin in Diabetic Patients (RITE)

PLx Pharma

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02008942

PL-ASA-006

Details and patient eligibility

About

This study will determine if aspirin from PL2200, an investigational product, gets into the blood stream as quickly as enteric coated aspirin, and to test whether PL2200 is able to prevent blood clots as effectively as enteric coated aspirin, when administered to patients with diabetes

Enrollment: 57 patients

Sex: All

Ages: 21 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-Insulin-Dependent Diabetes Mellitus
• Adults 21 to 79 years, inclusive
• Body mass index between 30 and 40 kg/m2, inclusive

Exclusion criteria

• Currently prescribed aspirin or anti-coagulants
• Contraindications to aspirin
• Significant disease history or active disease other than Non-Insulin-Dependent Diabetes Mellitus
• Patient requires insulin

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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57 participants in 2 patient groups

PL2200 Aspirin Capsules

Experimental group

Description:

PL2200 Aspirin Capsules

Treatment:

Drug: PL2200 Aspirin Capsules

Enteric-coated aspirin caplets

Active Comparator group

Description:

Enteric-coated aspirin caplets

Treatment:

Drug: Enteric-coated aspirin caplets