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Does metformin reduce growth rate of small abdominal aortic aneurysms?
EU CTIS ID: 2024-517387-37-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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: 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.
- 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.
See the full eligibility 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
- No history of diabetes mellitus and fasting p-glucose <7.0 mmol/L
- 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: 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.
- 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.
- 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. 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.