Type 2 Diabetes MellitusPhase 4NCT02786979

Efficacy and Safety of Dorner Tablets and Aspirin for Prevention of Arteriosclerosis Progress in Type 2 Diabetes Mellitus Patients

A Phase 4 study testing Beraprost and Aspirin in people with Type 2 Diabetes Mellitus, run by Astellas Pharma Inc at 6 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The objective was to evaluate the efficacy and safety of combination of beraprost and aspirin for prevention of arteriosclerosis progress in type 2 diabetes mellitus patients. Read more about this study

Who is it for?: Ages 50 to 75 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Beraprost and Aspirin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 190 participants
Where: 6 sitesChina
Study dates: Jul 2010to Jan 2013
Phase: Phase 4
Are there results?: None posted in the registry

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 50 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients diagnosed as type 2 diabetes mellitus;
Patients who had the intima-media thickness (IMT) of carotid artery ≥1.1 mm in at least one side;
Patients who had results of aspartate aminotransferase, alanine aminotransferase, and serum creatinine no more than 1.5 times higher than the upper limit of normal;
Patients who had not cardio or cerebral vascular events within 3 months, including non-fatal myocardial infarction, stable and unstable angina pectoris, and non-fatal cerebral ischemic and hemorrhagic stroke;
Patients who had their systolic blood pressure <160 mmHg, diastolic blood pressure <100 mmHg, and glycated hemoglobin (HbA1c) <8.0%;
Patients who had not taken any medications with antithrombotic and antiplatelet effect within 3 months;

Who cannot join

Patients who had peptic ulcer or active alimentary tract hemorrhage;
Patients who had a known allergy to prostacycline or non-steroid medications;
Patients who were pregnant, breast feeding, or had planned to be pregnant;
Patients who were attending or had attended any clinical studies within 3 months;

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

China6 sites

Site CN00001
Beijing, Beijing Municipality
Site CN00002
Beijing, Beijing Municipality
Site CN00005
Chengdu, Sichuan
Site CN00004
Guangzhou, Guangdong
Site CN00003
Shanghai, Shanghai Municipality
Site CN00006
Tianjin, Tianjin Municipality

Other trials in China

About this study

Official title: Combination of Beraprost Sodium Tablets (Dorner) and Aspirin for Prevention of Arteriosclerosis Progress in Type 2 Diabetes Mellitus Patients

The objective was to evaluate the efficacy and safety of combination of beraprost and aspirin for prevention of arteriosclerosis progress in type 2 diabetes mellitus patients.

Conditions: Type 2 Diabetes Mellitus
Being tested: Beraprost, Aspirin
Keywords: Type 2 Diabetes Mellitus, Arteriosclerosis, beraprost, Aspirin
Medical subject headings: Diabetes Mellitus, Type 2, Arteriosclerosis

What participants receive

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

BeraprostDrug
Also called Dorner (R)
Oral
AspirinDrug
Oral

Study groups in NCT02786979
Study group	Role	What they receive
Beraprost sodium tablet and Aspirin combination group	Experimental	Oral Receives: Drug: Beraprost; Drug: Aspirin
Aspirin Group	Experimental	Oral Receives: Drug: Aspirin

What is being measured

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

Change from baseline in carotid intima-media thickness
Measured: Baseline to Year 3
Incidence and severity of treatment-emergent adverse events
Measured: Up to 3 years
Safety assessed by vital signs: body temperature
Measured: Up to 3 years
Safety assessed by vital signs: pulse rate
Measured: Up to 3 years
Safety assessed by vital signs: respiratory rate
Measured: Up to 3 years
Safety assessed by vital signs: blood pressure (systolic blood pressure and diastolic blood pressure)
Measured: Up to 3 years
Number of participants with abnormal laboratory values and/or adverse events related to treatment
Measured: Up to 3 years

Secondary outcomes (7)

Death rate
Measured: Up to 3 years
Incidence of any vascular event
Vascular events include sudden death, death caused by the vascular event, non-fatal coronary hear disease (CHD), non-fatal cerebrovascular diseases, and non-fatal aorta and peripheral artery disease (PAD)
Measured: Baseline to Year 3
Change from baseline in Ankle-brachial index
Measured: Baseline to Year 3
Change from baseline in Pulse wave velocity
Measured: Baseline to Year 3
Change from baseline in Oxidative stress indices
Oxidative stress indices: superoxide dismutase and nitrotyrosine
Measured: Baseline to Year 3
Change from baseline in value of VCAM-1
VCMA-1: vascular cell adhesion molecule
Measured: Baseline to Year 3
Change from baseline in value of TNF-α
TNF: tumor necrosis factor
Measured: Baseline to Year 3

Timeline

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

Jul 2010Jan 2013

First posted1 Jun 2016 (estimated)
Study startJul 2010
Primary completionJan 2013
Study completionJan 2013

Why it stopped: Upon interim analysis, sponsor's decision due to absence of demonstration of efficacy.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 2 Diabetes MellitusStudies 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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 190 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02786979
Sponsor's protocol ID: DorDM002
Status last verified: May 2016
First submitted: 26 May 2016
Last updated: 21 Jun 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

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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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Combination of Beraprost Sodium Tablets (Dorner) and Aspirin for Prevention of Arteriosclerosis Progress in Type 2 Diabetes Mellitus Patients
ClinicalTrials.gov ID: NCT02786979
Acronym / sponsor ID: DorDM002
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus, Arteriosclerosis, beraprost, Aspirin
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Upon interim analysis, sponsor's decision due to absence of demonstration of efficacy.
Enrolment: 190 participants (actual)
Lead sponsor: Astellas Pharma IncIndustry (pharma, biotech, devices)
Study start: Jul 2010
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 1 Jun 2016 (estimated)
Results: Not posted in the source record

Clinical summary

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

The objective was to evaluate the efficacy and safety of combination of beraprost and aspirin for prevention of arteriosclerosis progress in type 2 diabetes mellitus patients.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Beraprost sodium tablet and Aspirin combination group	Experimental	Drug: Beraprost, Drug: AspirinOral
Aspirin Group	Experimental	Drug: AspirinOral

Who may qualify

Ages: 50 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Patients diagnosed as type 2 diabetes mellitus;
Patients who had the intima-media thickness (IMT) of carotid artery ≥1.1 mm in at least one side;
Patients who had results of aspartate aminotransferase, alanine aminotransferase, and serum creatinine no more than 1.5 times higher than the upper limit of normal;
Patients who had not cardio or cerebral vascular events within 3 months, including non-fatal myocardial infarction, stable and unstable angina pectoris, and non-fatal cerebral ischemic and hemorrhagic stroke;
Patients who had their systolic blood pressure <160 mmHg, diastolic blood pressure <100 mmHg, and glycated hemoglobin (HbA1c) <8.0%;

Key exclusion criteria (4 listed)

Patients who had peptic ulcer or active alimentary tract hemorrhage;
Patients who had a known allergy to prostacycline or non-steroid medications;
Patients who were pregnant, breast feeding, or had planned to be pregnant;
Patients who were attending or had attended any clinical studies within 3 months;

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
BeraprostAlso: Dorner (R)Oral	Drug	Beraprost sodium tablet and Aspirin combination group
AspirinOral	Drug	Aspirin Group, Beraprost sodium tablet and Aspirin combination group

Primary outcome

Change from baseline in carotid intima-media thickness
Time frame: Baseline to Year 3
Incidence and severity of treatment-emergent adverse events
Time frame: Up to 3 years
Safety assessed by vital signs: body temperature
Time frame: Up to 3 years
Safety assessed by vital signs: pulse rate
Time frame: Up to 3 years
Safety assessed by vital signs: respiratory rate
Time frame: Up to 3 years
Safety assessed by vital signs: blood pressure (systolic blood pressure and diastolic blood pressure)
Time frame: Up to 3 years
Number of participants with abnormal laboratory values and/or adverse events related to treatment
Time frame: Up to 3 years

7 secondary outcomes

Death rate
Time frame: Up to 3 years
Incidence of any vascular event
Time frame: Baseline to Year 3
Change from baseline in Ankle-brachial index
Time frame: Baseline to Year 3
Change from baseline in Pulse wave velocity
Time frame: Baseline to Year 3
Change from baseline in Oxidative stress indices
Time frame: Baseline to Year 3
Change from baseline in value of VCAM-1
Time frame: Baseline to Year 3
Change from baseline in value of TNF-α
Time frame: Baseline to Year 3

Results and safety

The study was stopped early (reason given: Upon interim analysis, sponsor's decision due to absence of demonstration of efficacy.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
Individual participant dataSharing planned: Undecided

Related trials for Type 2 Diabetes Mellitus

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.

Medical Director study director

Astellas Pharma Inc

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Beraprost and Aspirin in people with Type 2 Diabetes Mellitus, run by Astellas Pharma Inc at 6 sites in China.

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 6 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: stopped early, as of the sponsor's last update on 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

The study was stopped early (reason given: Upon interim analysis, sponsor's decision due to absence of demonstration of efficacy.). Results are not available in the source record.

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?

Change from baseline in carotid intima-media thickness (time frame: Baseline to Year 3). The study lists 7 primary outcomes in all. 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 NCT02786979.

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 21 Jun 2016.