Diabetes Mellitus, Type 2
Conditions
Brief 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
Interventions
325 mg aspirin; once per day for 10 days
325 mg aspirin; once per day for 10 days
Sponsors
PLx Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to 99% Inhibition of Serum Thromboxane | 11 days | Serial measurements of aspirin anti-platelet activity will be collected over 11 days, and compared between groups, to allow a determination of pharmacodynamic (anti-platelet) bioequivalence between study drugs. Aspirin's antiplatelet activity is measured by the capacity of platelets to generate serum thromboxane (a surrogate marker for inhibition of COX-1 by aspirin). Inhibition of serum thromboxane is a key marker of antiplatelet efficacy. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All patients that received at least 1 dose of study drug | 57 |
| Total | 57 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 54.8 years STANDARD_DEVIATION 10.06 |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 57 | 2 / 56 |
| serious Total, serious adverse events | 0 / 57 | 0 / 56 |
Outcome results
Primary
Time to 99% Inhibition of Serum Thromboxane
Serial measurements of aspirin anti-platelet activity will be collected over 11 days, and compared between groups, to allow a determination of pharmacodynamic (anti-platelet) bioequivalence between study drugs. Aspirin's antiplatelet activity is measured by the capacity of platelets to generate serum thromboxane (a surrogate marker for inhibition of COX-1 by aspirin). Inhibition of serum thromboxane is a key marker of antiplatelet efficacy.
Time frame: 11 days
Population: Pharmacodynamic (PD) Evaluable Population - patients in the intent-to-treat population who received a full treatment regimen for each of 2 study drugs, had all scheduled PD blood draws, and had no other major protocol violations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PL2200 Aspirin Capsules | Time to 99% Inhibition of Serum Thromboxane | 26.71 hours | Standard Deviation 62.758 |
| Enteric-coated Aspirin Caplets | Time to 99% Inhibition of Serum Thromboxane | 64.57 hours | Standard Deviation 72.842 |