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

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

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

Key facts

Study ID

NCT02008942

Run by

PLx Pharma

People needed

57

Starts

2014-01-01

Expected to finish

2014-04-01

Last updated by the study team

2016-03-10

Who can join

Age: 21 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Miami Research Associates — Miami, Florida, United States
• PRA Clinical Pharmacology Center — Lenexa, Kansas, United States
• Medpace Clinical Pharmacology — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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