Diabetes Mellitus, Type 2Phase 3NCT01515657

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

A Phase 3 study testing PL2200 Aspirin Capsules, Immediate-Release Aspirin Tablets and Enteric-coated aspirin caplets in people with Diabetes Mellitus, Type 2, run by PLx Pharma at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 21 to 79 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: PL2200 Aspirin Capsules, Immediate-Release Aspirin Tablets and Enteric-coated aspirin caplets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: Jan 2012to Jun 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

MedPace Clinical Pharmacology
Cincinnati, Ohio, 45212

Other trials in United States

About this study

Official title: A Randomized, Actively Controlled, Crossover Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Patients With Type II Diabetes

Conditions: Diabetes Mellitus, Type 2
Being tested: PL2200 Aspirin Capsules, Immediate-Release Aspirin Tablets, Enteric-coated aspirin caplets
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PL2200 Aspirin CapsulesDrug
325 mg aspirin; once per day for 3 days
Immediate-Release Aspirin TabletsDrug
325 mg aspirin; once per day for 3 days
Enteric-coated aspirin capletsDrug
325 mg aspirin; once per day for 3 days

Study groups in NCT01515657
Study group	Role	What they receive
PL2200 Aspirin Capsules	Experimental	Investigational drug arm; crossover design Receives: Drug: PL2200 Aspirin Capsules
Immediate-Release Aspirin Tablets	Active comparator	Active comparator; crossover design Receives: Drug: Immediate-Release Aspirin Tablets
Enteric-coated aspirin caplets	Active comparator	Active comparator; crossover design Receives: Drug: Enteric-coated aspirin caplets

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 4 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Jun 2012

First posted24 Jan 2012 (estimated)
Study startJan 2012
Primary completionJun 2012
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01515657
Sponsor's protocol ID: PL-ASA-004
Status last verified: Feb 2016
First submitted: 13 Jan 2012
Last updated: 14 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 28089180

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Actively Controlled, Crossover Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Patients With Type II Diabetes
ClinicalTrials.gov ID: NCT01515657
Acronym / sponsor ID: PL-ASA-004
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: PLx PharmaIndustry (pharma, biotech, devices)
Study start: Jan 2012
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 24 Jan 2012 (estimated)
Results: Posted 4 Sep 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
PL2200 Aspirin Capsules	Experimental	Drug: PL2200 Aspirin CapsulesInvestigational drug arm; crossover design
Immediate-Release Aspirin Tablets	Active comparator	Drug: Immediate-Release Aspirin TabletsActive comparator; crossover design
Enteric-coated aspirin caplets	Active comparator	Drug: Enteric-coated aspirin capletsActive comparator; crossover design

Who may qualify

Ages: 21 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PL2200 Aspirin Capsules325 mg aspirin; once per day for 3 days	Drug	PL2200 Aspirin Capsules
Immediate-Release Aspirin Tablets325 mg aspirin; once per day for 3 days	Drug	Immediate-Release Aspirin Tablets
Enteric-coated aspirin caplets325 mg aspirin; once per day for 3 days	Drug	Enteric-coated aspirin caplets

Primary outcome

Time to 99% Inhibition of Serum Thromboxane (TxB2)
Time frame: 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.

Results and safety

Results posted to the registry on 4 Sep 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PL2200 Aspirin First, Then IR Aspirin Tablets, Then EC Aspirin	14	14
IR Aspirin Tablets First, Then EC Aspirin, Then PL2200 Aspirin	13	12
EC Aspirin First, Then PL2200 Aspirin, Then IR Aspirin Tablets	13	13

Primary outcome: Time to 99% Inhibition of Serum Thromboxane (TxB2)

Time frame: 4 days. Mean (Standard Deviation). Unit: Hours

Measure	PL2200 Aspirin Capsules n = 35	Immediate-Release Aspirin Tablets n = 35	Enteric-coated Aspirin Caplets n = 35
Value	12.36 (23.42)	16.65 (27.21)	48.64 (31.20)

Population analysed: Pharmacodynamic (PD) Evaluable Population for Time to 99% Inhibition

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PL2200 Aspirin Capsules	0 of 38 (0%)	2 of 38 (5.3%)	Not reported
Immediate-Release Aspirin Tablets	0 of 40 (0%)	4 of 40 (10%)	Not reported
Enteric-coated Aspirin Caplets	0 of 38 (0%)	7 of 38 (18.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28089180Bhatt 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to 99% Inhibition of Serum Thromboxane (TxB2) (time frame: 4 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01515657, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2016.