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 plain aspirin and enteric coated aspirin, and to test whether PL2200 is able to prevent blood clots as effectively as these other products, when administered to patients with diabetes.
Interventions
325 mg aspirin; once per day for 3 days
DRUGImmediate-Release Aspirin Tablets
325 mg aspirin; once per day for 3 days
325 mg aspirin; once per day for 3 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
* Adults 21-79 * Body mass index (BMI) of 30-40 kg/m2 * Non-insulin-dependent type-2 diabetics (as confirmed by hemoglobin A1c (HbA1c) of \> 6.4% and/or fasting plasma glucose of \>125 mg/dL or current anti-diabetic medication) * AA-induced platelet aggregation response of \>60% within 3 hours prior to initial dose of study drug administration
Exclusion criteria
* Contraindications to aspirin * Previous history of vascular disease * Patient requires insulin * Use of non-steroidal anti-inflammatory drugs, anti-secretory agents, antacids, and salicylate-containing nutritional supplements within 2 weeks of randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to 99% Inhibition of Serum Thromboxane (TxB2) | 4 days | 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 under the study protocol. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 52.9 years STANDARD_DEVIATION 10.12 |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 38 | 4 / 40 | 7 / 38 |
| serious Total, serious adverse events | 0 / 38 | 0 / 40 | 0 / 38 |
Outcome results
Primary
Time to 99% Inhibition of Serum Thromboxane (TxB2)
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: 4 days
Population: Pharmacodynamic (PD) Evaluable Population for Time to 99% Inhibition
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PL2200 Aspirin Capsules | Time to 99% Inhibition of Serum Thromboxane (TxB2) | 12.36 Hours | Standard Deviation 23.42 |
| Immediate-Release Aspirin Tablets | Time to 99% Inhibition of Serum Thromboxane (TxB2) | 16.65 Hours | Standard Deviation 27.21 |
| Enteric-coated Aspirin Caplets | Time to 99% Inhibition of Serum Thromboxane (TxB2) | 48.64 Hours | Standard Deviation 31.2 |