Abdominal Aortic AneurysmPhase 2MAAAGINCT04224051
Metformin for Abdominal Aortic Aneurysm Growth Inhibition
A Phase 2 study testing Metformin in people with Abdominal Aortic Aneurysm, run by Uppsala University Hospital at 1 site in Sweden.
Trial summary
A multi-centre population-based open-label randomized controlled trial with allocation concealment and blinded outcome assessment will examine if up to 2g metformin daily slows AAA growth in patients with small AAAs who do not have diabetes. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSweden
- Study dates
- 12 Feb 2020to Jan 2026
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of written informed consent.
- Male and female patients.
- Age 50-80 years.
- Documented AAA Ø 30-49 mm for men and 30-44 mm for women.
- Fasting p-glucose <7.0 mmol/L. Fasting is defined as no caloric intake for ≥8 h.
Who cannot join
- Short expected survival.
- History of current or previous diabetes mellitus.
- Current or previous use of metformin.
- Not expected to tolerate metformin.
- Contraindications to metformin treatment according to SmPC
- Known or suspected connective tissue disorder (Marfans syndrome, etc), infected or inflammatory aneurysm, aneurysm development after aortic dissection or previous surgery of the infrarenal aorta.
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- Enrollment in either another investigational drug or medical device study or another investigational study of an approved drug or medical device within 30 days prior to enrollment of the current study.
- If, in the opinion of the investigator, it is not in the patient's medical interest to participate in the study or the patient is unlikely to be able to comply with the study protocol.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metformin for AAA Growth Inhibition, a Randomized Controlled Trial
A multi-centre population-based open-label randomized controlled trial with allocation concealment and blinded outcome assessment will examine if up to 2g metformin daily slows AAA growth in patients with small AAAs who do not have diabetes.
Read the detailed description
Subjects with no history of diabetes will be recruited from a cohort of patients with diagnosed AAA and a maximum aortic diameter of 30-49mm for men and 30-44mm for women.
A total of 500 subjects with AAA will be included in the study, 250 in each study arm. Patients will be randomised to metformin or standard care in a 1:1 ratio.
CT imaging and AAA US will be performed at baseline, 24 months and end of study, as well as if necessary according to clinical routine. Study drug will start at baseline and continue through completion.
When all enrolled subjects have completed the 24-month follow-up (including imaging) an interim analysis will be performed to assess for efficacy and safety; if there is no trend towards a positive effect or signs of a harmful effect of metformin, the study will be stopped at this phase.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Metformin, Standard care
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Metformin target dose 2 g daily
Standard careOther
Abdominal aortic aneurysm surveillance
| Study group | Role | What they receive |
|---|---|---|
| Metformin target dose of 2g daily | Experimental | Metformin tablets taken orally with target dose of 2g daily plus standard care Receives: Drug: Metformin |
| Standard care | Active comparator | Standard care includes help with smoking cessation if applicable; encouragement of physical activity and a healthy diet; blood pressure control; statin and anti-platelet therapy treatment if the patient have clinical manifestations of atherosclerotic disease. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal aortic aneurysm (AAA) diameter growth rate
To examine if up to 2g metformin administered daily over a five-year period slows AAA growth measured as computed tomography (CT) imaging assessed AAA diameter (mm) in patients with small AAAs who do not have diabetes.
Measured: 5 years
Secondary outcomes (1)
Abdominal aortic aneurysm (AAA) volume growth rate
To examine if up to 2g metformin administered daily over a five-year period slows AAA growth measured as computed tomography (CT) imaging assessed AAA volume (ml) in patients with small AAAs who do not have diabetes.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start12 Feb 2020
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jon Unosson, Uppsala University Hospital
- Investigators
- Jon Unosson, PhD, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224051
- Sponsor's protocol ID
- MAAAGI
- Acronym
- MAAAGI
- Status last verified
- Sep 2023
- First submitted
- 1 Jan 2020
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin for AAA Growth Inhibition, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04224051
- Acronym / sponsor ID
- MAAAGI / MAAAGI
- Conditions
- Abdominal Aortic Aneurysm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 13 Jan 2020 (actual)
- 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.
A multi-centre population-based open-label randomized controlled trial with allocation concealment and blinded outcome assessment will examine if up to 2g metformin daily slows AAA growth in patients with small AAAs who do not have diabetes.
Detailed description
Subjects with no history of diabetes will be recruited from a cohort of patients with diagnosed AAA and a maximum aortic diameter of 30-49mm for men and 30-44mm for women.
A total of 500 subjects with AAA will be included in the study, 250 in each study arm. Patients will be randomised to metformin or standard care in a 1:1 ratio.
CT imaging and AAA US will be performed at baseline, 24 months and end of study, as well as if necessary according to clinical routine. Study drug will start at baseline and continue through completion.
When all enrolled subjects have completed the 24-month follow-up (including imaging) an interim analysis will be performed to assess for efficacy and safety; if there is no trend towards a positive effect or signs of a harmful effect of metformin, the study will be stopped at this phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin target dose of 2g daily | Experimental | Drug: MetforminMetformin tablets taken orally with target dose of 2g daily plus standard care |
| Standard care | Active comparator | Other: Standard careStandard care includes help with smoking cessation if applicable; encouragement of physical activity and a healthy diet; blood pressure control; statin and anti-platelet therapy treatment if the patient have clinical manifestations of atherosclerotic disease. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of written informed consent.
- Male and female patients.
- Age 50-80 years.
- Documented AAA Ø 30-49 mm for men and 30-44 mm for women.
- Fasting p-glucose <7.0 mmol/L. Fasting is defined as no caloric intake for ≥8 h.
Key exclusion criteria (9 listed)
- Short expected survival.
- History of current or previous diabetes mellitus.
- Current or previous use of metformin.
- Not expected to tolerate metformin.
- Contraindications to metformin treatment according to SmPC
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 |
|---|---|---|
| MetforminMetformin target dose 2 g daily | Drug | Metformin target dose of 2g daily |
| Standard careAbdominal aortic aneurysm surveillance | Other | Standard care |
Primary outcome
Abdominal aortic aneurysm (AAA) diameter growth rate
Time frame: 5 years
To examine if up to 2g metformin administered daily over a five-year period slows AAA growth measured as computed tomography (CT) imaging assessed AAA diameter (mm) in patients with small AAAs who do not have diabetes.
1 secondary outcome
Abdominal aortic aneurysm (AAA) volume growth rate
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Jon Unosson, PhD principal investigator
Uppsala University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin in people with Abdominal Aortic Aneurysm, run by Uppsala University Hospital 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 9 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: status not confirmed, as of the sponsor's last update on 6 Sep 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Abdominal aortic aneurysm (AAA) diameter growth rate (time frame: 5 years). 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 6 Sep 2023.