Phase 3
N=57
Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated Aspirin in Diabetic Patients
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT02008942 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcome: Primary: Time to 99% Inhibition of Serum Thromboxane — 26.71; 64.57 hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PL2200 Aspirin Capsules (Drug); Enteric-coated aspirin caplets (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- PLx Pharma
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to 99% Inhibition of Serum Thromboxane |
26.71; 64.57 | — |
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
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
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.