Metformin for Abdominal Aortic Aneurysm Growth Inhibition

Brief Title

Metformin for Abdominal Aortic Aneurysm Growth Inhibition

Official Title

Metformin for AAA Growth Inhibition, a Randomized Controlled Trial

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.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Abdominal aortic aneurysm (AAA) diameter growth rate

Secondary Outcome

 Abdominal aortic aneurysm (AAA) volume growth rate

Condition

Abdominal Aortic Aneurysm

Intervention

Metformin

Study Arms / Comparison Groups

 Metformin target dose of 2g daily

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

500

Start Date

February 12, 2020

Completion Date

January 2026

Primary Completion Date

January 2026

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.
      

Gender

All

Ages

50 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Jon Unosson, PhD, , 

Location Countries

Sweden

Location Countries

Sweden

NCT ID

NCT04224051

Organization ID

MAAAGI

Responsible Party

Principal Investigator

Study Sponsor

Uppsala University Hospital

Study Sponsor

Jon Unosson, PhD, Principal Investigator, Uppsala University Hospital

Verification Date

August 2020