Metformin for Abdominal Aortic Aneurysm Growth Inhibition

STATUS

Recruiting
End date

Jan 28, 2026
participants needed

500
sponsor

Uppsala University Hospital

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Updated on 19 February 2024

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diabetes

aortic aneurysm

aaas

metformin

aneurysm

abdominal aortic aneurysm

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.

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.

Details

Condition	Abdominal aortic aneurysm
Age	50-80 years
Treatment	Standard care, Metformin
Clinical Study Identifier	NCT04224051
Sponsor	Uppsala University Hospital
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Provision of written informed consent
	Male and female patients
	Age 50-80 years
	Documented AAA 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

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Metformin for Abdominal Aortic Aneurysm Growth Inhibition