Type 2 Diabetes MellitusPhase 4DM-ASA 001NCT00812032
Evaluation of Antiplatelet Effects of Different Dosages of Aspirin in Type 2 Diabetic Patients
A Phase 4 study testing Aspirin in people with Type 2 Diabetes Mellitus, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The efficacy of low dose aspirin appears to be substantially lower in diabetic patients, compared to patients without diabetes. The aim of the investigators study is to test the laboratory response to different dosing of aspirin in type 2 Diabetes Mellitus. 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?
- Aspirin
- How many people
- 25 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2008to Oct 2010
- 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
- Type 2 DM with micro- or macroangiopathy.
- HbA1c 6-9 % (Mono-S method).
- Need for, or already on-going aspirin treatment.
- Age 50-75 years
- Antecubital forearm veins allowing technically good sampling for platelet studies
Who cannot join
- Diet controlled DM.
- Acute ischemic stroke, acute coronary syndrome, (myocardial infarction or unstable angina pectoris), or revascularization by PCI or by-pass surgery within the last 6 months.
- Acute or chronic kidney disease (P-cystatin C within the reference interval)
- Acute or chronic liver disease (ALAT ≤2 times the upper reference value).
- A history of gastric or duodenal ulcer disease.
- Need for treatment with anticoagulants, clopidogrel, NSAID's, or thiazolidinediones.
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- Thrombocytopenia (platelet count <150 x 109/L)
- Anticipated need for alteration of concomitant drug therapy during the course of the study.
- Enrollment in another clinical study.
- Contraindication(s) to aspirin treatment.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Medicine, Clinical pharmacology Unit, Karolinska University Hospital, Solna.
Stockholm
About this study
The efficacy of low dose aspirin appears to be substantially lower in diabetic patients, compared to patients without diabetes. The aim of the investigators study is to test the laboratory response to different dosing of aspirin in type 2 Diabetes Mellitus. The investigators will compare the regular dose of 75mg once daily to 75 mg twice daily or to 320 mg once daily. The hypothesis of the study is that twice daily dosing of aspirin may improve the response to aspirin.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Aspirin
- Keywords
- NIDDM, Aspirin, platelet inhibition, Aspirin treatment
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
An exploratory study with three co-primary response variables which are directly related to platelet COX-1 inhibition: arachidonic acid-induced platelet aggregation in whole blood and PRP and in the Cone-and-Plate(let) Assay (CPA)
Measured: 12 or 24 hours after last dose of Aspirin
Secondary outcomes (1)
Indirectly COX-related platelet aggregation induced by collagen or ADP, and thromboxane metabolite excretion.
Measured: 12 or 24 hours after last dose of aspirin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startJan 2008
- Primary completionOct 2010
- Study completionOct 2010
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.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Hjemdahl, Karolinska Institutet
- Investigators
- Paul Hjemdahl, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812032
- Sponsor's protocol ID
- EudraCT No: 2007-003186-40
- Acronym
- DM-ASA 001
- Status last verified
- May 2022
- First submitted
- 18 Dec 2008
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Antiplatelet Effects of Different Dosages of Aspirin in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT00812032
- Acronym / sponsor ID
- DM-ASA 001 / EudraCT No: 2007-003186-40
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- NIDDM, Aspirin, platelet inhibition, Aspirin treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 19 Dec 2008 (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 efficacy of low dose aspirin appears to be substantially lower in diabetic patients, compared to patients without diabetes. The aim of the investigators study is to test the laboratory response to different dosing of aspirin in type 2 Diabetes Mellitus. The investigators will compare the regular dose of 75mg once daily to 75 mg twice daily or to 320 mg once daily. The hypothesis of the study is that twice daily dosing of aspirin may improve the response to aspirin.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 DM with micro- or macroangiopathy.
- HbA1c 6-9 % (Mono-S method).
- Need for, or already on-going aspirin treatment.
- Age 50-75 years
- Antecubital forearm veins allowing technically good sampling for platelet studies
Key exclusion criteria (10 listed)
- Diet controlled DM.
- Acute ischemic stroke, acute coronary syndrome, (myocardial infarction or unstable angina pectoris), or revascularization by PCI or by-pass surgery within the last 6 months.
- Acute or chronic kidney disease (P-cystatin C within the reference interval)
- Acute or chronic liver disease (ALAT ≤2 times the upper reference value).
- A history of gastric or duodenal ulcer disease.
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 |
|---|---|---|
| AspirinAlso: Trombyl75 mg per day versus 75 mg twice daily and 320mg once daily | Drug | – |
| aspirinAlso: Trombylcrossover study with three dosages: 75 mg once daily, 75 mg twice daily, 320 mg once daily. | Drug | – |
Primary outcome
An exploratory study with three co-primary response variables which are directly related to platelet COX-1 inhibition: arachidonic acid-induced platelet aggregation in whole blood and PRP and in the Cone-and-Plate(let) Assay (CPA)
Time frame: 12 or 24 hours after last dose of Aspirin
1 secondary outcome
Indirectly COX-related platelet aggregation induced by collagen or ADP, and thromboxane metabolite excretion.
Time frame: 12 or 24 hours after last dose of aspirin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
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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.
Paul Hjemdahl, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin in people with Type 2 Diabetes Mellitus, run by Karolinska Institutet at 1 site in Sweden.
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 5 inclusion and 10 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 27 May 2022. 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 Sweden. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
An exploratory study with three co-primary response variables which are directly related to platelet COX-1 inhibition: arachidonic acid-induced platelet aggregation in whole blood and PRP and in the Cone-and-Plate(let) Assay (CPA) (time frame: 12 or 24 hours after last dose of Aspirin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2022.