Back to resultsMetformin for Abdominal Aortic Aneurysm Growth Inhibition (MAAAGI)
Primary Purpose
Abdominal Aortic Aneurysm
Status
Enrolling by invitation
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Metformin
Standard care
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Aortic Aneurysm
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Uppsala University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Metformin target dose of 2g daily
Standard care
Arm Description
Metformin tablets taken orally with target dose of 2g daily plus standard care
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04224051
First Posted
January 1, 2020
Last Updated
September 5, 2023
Sponsor
Uppsala University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04224051
Brief Title
Metformin for Abdominal Aortic Aneurysm Growth Inhibition
Acronym
MAAAGI
Official Title
Metformin for AAA Growth Inhibition, a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 12, 2020 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Metformin target dose of 2g daily
Arm Type
Experimental
Arm Description
Metformin tablets taken orally with target dose of 2g daily plus standard care
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Metformin target dose 2 g daily
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Abdominal aortic aneurysm surveillance
Primary Outcome Measure Information:
Title
Abdominal aortic aneurysm (AAA) diameter growth rate
Description
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.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Abdominal aortic aneurysm (AAA) volume growth rate
Description
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.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Unosson, PhD
Organizational Affiliation
Uppsala University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University Hospital
City
Uppsala
State/Province
Sverige
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Metformin for Abdominal Aortic Aneurysm Growth Inhibition
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