Phase 3 Completed N=57 Randomized Single-blind Prevention

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

Type 2 Diabetes Mellitus

Source: ClinicalTrials.gov NCT02008942 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2015

Primary outcomePrimary: Time to 99% Inhibition of Serum Thromboxane — 26.71; 64.57 hours

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to 99% Inhibition of Serum Thromboxane	26.71; 64.57	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02008942). 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.