Does metformin reduce growth rate of small abdominal aortic aneurysms?
Key facts
- Where
- Copenhagen Oe, DenmarkSee the site
- Phase
- Phase 2
Where in Denmark
- Copenhagen University HospitalCopenhagen Oe, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Uppsala University
- Trial code
- NCT04224051EU 2024-517387-37-00
- Record updated
- 15 November 2024
- Original description
To investigate if 2 g metformin daily over 60 months reduce yearly growth rate of small abdominal aortic aneurysms in patients with no history of diabetes. At 24 months a Stop/Go interim analysis will be performed for safety and efficacy.Read full original descriptionShow less
Metformin for Abdominal Aortic Aneurysm Inhibition (MAAAGI) A randomized controlled trial
To investigate if 2 g metformin daily over 60 months reduce yearly growth rate of small abdominal aortic aneurysms in patients with no history of diabetes. At 24 months a Stop/Go interim analysis will be performed for safety and efficacy.
Inclusion: 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; No history of diabetes mellitus and fasting p-glucose <7.0 mmol/L.
Exclusion: History of current or previous diabetes mellitus; Current or previous use of metformin; 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; Enrolment 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; Contraindications to metformin treatment according to SmPC: a) Renal failure with glomerular filtration rate (GFR) <45ml/min according to the revised Lund-Malmö formula. b) Hypersenisitivity to metformin or any of the excipients included in the tablet. c) Acute metabolic acidosis. d) Diabetic pre-coma. e) Acute conditions with the potential to alter renal function such as; dehydration, severe infection or shock. f) Acute or chronic disease which may cause tissue hypoxia such as; decompensated heart failure, respiratory failure, recent myocardial infarction or shock. g) Hepatic insufficiency, acute alcohol intoxication, alcoholism; Pregnancy. Women of childbearing potential are only included after a confirmed menstrual period and a negative highly sensitive urine or serum pregnancy test as well as willingness to comply with highly effective anti-contraception throughout the study period; Short expected survival; Not expected to tolerate metformin; 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.