NCT04224051

Metformin for Abdominal Aortic Aneurysm Growth Inhibition

Metformin for AAA Growth Inhibition, a Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Uppsala University Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Abdominal Aortic Aneurysm

Interventions

Type	Name	Description
DRUG	Metformin	Metformin target dose 2 g daily
OTHER	Standard care	Abdominal aortic aneurysm surveillance

Timeline

• Start date: 2020-02-12
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2020-01-13
• Last updated: 2023-09-06

Locations

1 site across 1 country: Sweden