NCT01515657

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_3 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

September 4, 2015

Completed
Last Updated

March 14, 2016

Status Verified

February 1, 2016

Enrollment Period

5 months

First QC Date

January 13, 2012

Results QC Date

June 22, 2015

Last Update Submit

February 11, 2016

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 days

Study Arms (3)

PL2200 Aspirin Capsules

EXPERIMENTAL

Investigational drug arm; crossover design

Drug: PL2200 Aspirin Capsules

Immediate-Release Aspirin Tablets

ACTIVE COMPARATOR

Active comparator; crossover design

Drug: Immediate-Release Aspirin Tablets

Enteric-coated aspirin caplets

ACTIVE COMPARATOR

Active comparator; crossover design

Drug: Enteric-coated aspirin caplets

Interventions

PL2200 Aspirin CapsulesDRUG

325 mg aspirin; once per day for 3 days

PL2200 Aspirin Capsules
Immediate-Release Aspirin TabletsDRUG

325 mg aspirin; once per day for 3 days

Immediate-Release Aspirin Tablets
Enteric-coated aspirin capletsDRUG

325 mg aspirin; once per day for 3 days

Enteric-coated aspirin caplets

Eligibility Criteria

Age21 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MedPace Clinical Pharmacology

Cincinnati, Ohio, 45212, United States

Location

Related Publications (1)

  • Bhatt DL, Grosser T, Dong JF, Logan D, Jeske W, Angiolillo DJ, Frelinger AL 3rd, Lei L, Liang J, Moore JE, Cryer B, Marathi U. Enteric Coating and Aspirin Nonresponsiveness in Patients With Type 2 Diabetes Mellitus. J Am Coll Cardiol. 2017 Feb 14;69(6):603-612. doi: 10.1016/j.jacc.2016.11.050. Epub 2017 Jan 11.

    PMID: 28089180DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Ronald Zimmerman
Organization
PLx Pharma
ron.zimmerman@plxpharma.com
1-713-842-1249

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2012

First Posted

January 24, 2012

Study Start

January 1, 2012

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

March 14, 2016

Results First Posted

September 4, 2015

Record last verified: 2016-02

Locations

US(1)