Does metformin reduce growth rate of small abdominal aortic aneurysms?

Phase 1

• Conditions: Small abdominal aortic aneurysm (AAA) under active surveillance; 30-49 mm in diameter for men and 30-44 mm in diameter for women; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-004289-33-SE
• Lead Sponsor: Department of Surgical, Sciences Uppsala University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-08
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1.Provision of written informed consent
2.Male and female patients
3.Age 50-80 years
4.Documented AAA Ø 30-49 mm for men and 30-44 mm for women
5.No history of diabetes mellitus and fasting p-glucose <7.0 mmol/L

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400

Exclusion Criteria

1.Short expected survival.
2.History of current or previous diabetes mellitus.
3.Current or previous use of metformin.
4.Not expected to tolerate metformin.
5.Contraindication to metformin according to summary of product characteristics (SmPc in FASS 2019) including: Renal failure with glomerular filtration rate (GFR) <45ml/min, progressing or unstable heart failure, recent myocardial infarction, liver impairment or alcoholism evidenced by patient history or clinical examination.
6.Known or suspected connective tissue disorder (Marfans syndrome, etc), infected or inflammatory aneurysm, aneurysm post aortic dissection or previous surgery of the infrarenal aorta.
7. Enrolled 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 enrolment of the current study.
8.Any condition or laboratory finding which in the opinion of the Investigator makes the patient unsuitable for inclusion.
9.Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified