Diabetes Mellitus, Type 2Phase 3RITENCT02008942

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

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

Completed

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

Official record

Search all trials

Trial 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 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 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: 57 participants
Where: 3 sitesUnited States
Study dates: Jan 2014to Apr 2014
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

Non-Insulin-Dependent Diabetes Mellitus
Adults 21 to 79 years, inclusive
Body mass index between 30 and 40 kg/m2, inclusive

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Medpace Clinical Pharmacology
Cincinnati, Ohio, 45227
PRA Clinical Pharmacology Center
Lenexa, Kansas, 66219
Miami Research Associates
Miami, Florida, 33143

Other trials in United States

About this study

Official title: Reliable Inhibition of Thrombocyte Activity: Comparison of PL2200 Aspirin Capsules, 325 mg and Enteric-Coated Aspirin (RITE Study)

Conditions: Diabetes Mellitus, Type 2
Being tested: PL2200 Aspirin Capsules, 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 10 days
Enteric-coated aspirin capletsDrug
325 mg aspirin; once per day for 10 days

Study groups in NCT02008942
Study group	Role	What they receive
PL2200 Aspirin Capsules	Experimental	PL2200 Aspirin Capsules Receives: Drug: PL2200 Aspirin Capsules
Enteric-coated aspirin caplets	Active comparator	Enteric-coated aspirin caplets 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
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.
Measured: 11 days

Timeline

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

Jan 2014Apr 2014

First posted11 Dec 2013 (estimated)
Study startJan 2014
Primary completionApr 2014
Study completionApr 2014

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.
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: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02008942
Sponsor's protocol ID: PL-ASA-006
Acronym: RITE
Status last verified: Feb 2016
First submitted: 6 Dec 2013
Last updated: 10 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reliable Inhibition of Thrombocyte Activity: Comparison of PL2200 Aspirin Capsules, 325 mg and Enteric-Coated Aspirin (RITE Study)
ClinicalTrials.gov ID: NCT02008942
Acronym / sponsor ID: RITE / PL-ASA-006
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: PLx PharmaIndustry (pharma, biotech, devices)
Study start: Jan 2014
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 11 Dec 2013 (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: 2

Arm	Type	Receives
PL2200 Aspirin Capsules	Experimental	Drug: PL2200 Aspirin CapsulesPL2200 Aspirin Capsules
Enteric-coated aspirin caplets	Active comparator	Drug: Enteric-coated aspirin capletsEnteric-coated aspirin caplets

Who may qualify

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

Key inclusion criteria (3 listed)

Non-Insulin-Dependent Diabetes Mellitus
Adults 21 to 79 years, inclusive
Body mass index between 30 and 40 kg/m2, inclusive

Key exclusion criteria (4 listed)

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

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 10 days	Drug	PL2200 Aspirin Capsules
Enteric-coated aspirin caplets325 mg aspirin; once per day for 10 days	Drug	Enteric-coated aspirin caplets

Primary outcome

Time to 99% Inhibition of Serum Thromboxane
Time frame: 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.

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 Enteric Coated (EC) Aspirin	27	27
Enteric Coated (EC) Aspirin First, Then PL2200 Aspirin	30	30

Primary outcome: Time to 99% Inhibition of Serum Thromboxane

Time frame: 11 days. Mean (Standard Deviation). Unit: hours

Measure	PL2200 Aspirin Capsules n = 55	Enteric-coated Aspirin Caplets n = 55
Value	26.71 (62.758)	64.57 (72.842)

Population analysed: 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.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PL2200 Aspirin Capsules	0 of 57 (0%)	2 of 57 (3.5%)	Not reported
Enteric-coated Aspirin Caplets	0 of 56 (0%)	2 of 56 (3.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetes Mellitus, Type 2

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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.

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

Questions about this trial

What is this clinical trial studying?

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

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 3 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 10 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 3 sites 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 (time frame: 11 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 NCT02008942.

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 10 Mar 2016.