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

This study has been completed.
Information provided by (Responsible Party):
PLx Pharma Identifier:
First received: January 13, 2012
Last updated: August 5, 2015
Last verified: August 2015
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 elderly patients with diabetes.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: PL2200 Aspirin Capsules
Drug: Immediate-Release Aspirin Tablets
Drug: Enteric-coated aspirin caplets
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Actively Controlled, Crossover Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Patients With Type II Diabetes

Resource links provided by NLM:

Further study details as provided by PLx Pharma:

Primary Outcome Measures:
  • Time to 99% Inhibition of Serum Thromboxane (TxB2) [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    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.

Enrollment: 40
Study Start Date: January 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PL2200 Aspirin Capsules
Investigational drug arm; crossover design
Drug: PL2200 Aspirin Capsules
325 mg aspirin; once per day for 3 days
Active Comparator: Immediate-Release Aspirin Tablets
Active comparator; crossover design
Drug: Immediate-Release Aspirin Tablets
325 mg aspirin; once per day for 3 days
Active Comparator: Enteric-coated aspirin caplets
Active comparator; crossover design
Drug: Enteric-coated aspirin caplets
325 mg aspirin; once per day for 3 days


Ages Eligible for Study:   50 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults 50-79
  • Non-insulin-dependent type-2 diabetics

Exclusion Criteria:

  • Contraindications to aspirin
  • Significant disease history or active disease other than type-2 diabetes
  • Patient requires insulin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01515657

United States, Ohio
MedPace Clinical Pharmacology
Cincinnati, Ohio, United States, 45212
Sponsors and Collaborators
PLx Pharma
  More Information

No publications provided

Responsible Party: PLx Pharma Identifier: NCT01515657     History of Changes
Other Study ID Numbers: PL-ASA-004
Study First Received: January 13, 2012
Results First Received: June 22, 2015
Last Updated: August 5, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents
Therapeutic Uses processed this record on November 24, 2015