Metformin for Abdominal Aortic Aneurysm Growth Inhibition

NCT ID: NCT04224051

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE2
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-12
• Study Completion Date: 2026-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metformin target dose of 2g daily

Metformin tablets taken orally with target dose of 2g daily plus standard care

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Metformin target dose 2 g daily

Standard care

Standard care includes help with smoking cessation if applicable; encouragement of physical activity and a healthy diet; blood pressure control; statin and anti-platelet therapy treatment if the patient have clinical manifestations of atherosclerotic disease.

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: OTHER

Abdominal aortic aneurysm surveillance

Interventions

Metformin

Metformin target dose 2 g daily

Intervention Type: DRUG

Standard care

Abdominal aortic aneurysm surveillance

Intervention Type: OTHER

Eligibility Criteria

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. Fasting p-glucose <7.0 mmol/L. Fasting is defined as no caloric intake for ≥8 h.

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. Contraindications to metformin treatment according to SmPC

6. 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.

7. 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.

8. 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.

9. Pregnancy.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jon Unosson

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jon Unosson, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University Hospital

Locations

Uppsala University Hospital

Uppsala, Sverige, Sweden

Countries

Sweden

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MAAAGI

Identifier Type: -

Identifier Source: org_study_id