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Abdominal Aortic AneurysmPhase 2/3MetAAANCT03507413

Metformin Therapy in Non-diabetic AAA Patients

A Phase 2/3 study testing Metformin Glucophage 500mg (IR) tablets M90 in people with Abdominal Aortic Aneurysm, run by Medical University of Vienna at 1 site in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A prospective randomized, double blind, placebo-controlled, safety and efficacy study of metformin as add-on therapy in abdominal aortic aneurysm (AAA) OBJECTIVES Primary Objective To demonstrate treatment efficacy of metformin in AAA in comparison to placebo or active comparator, as measured by growth of the AAA… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Abdominal Aortic Aneurysm
What is being tested?
Metformin Glucophage 500mg (IR) tablets M90
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
170 participants
Where
1 siteAustria
Study dates
26 Sep 2018to 1 May 2024
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Infrarenal AAA of 3-4.9 cm maximum diameter

Who cannot join

  • premenopausal female patients with a pregnancy possibility
  • patients with diabetes
  • indication for surgical AAA repair
  • contraindications for metformin, i.e. severly reduced kidney function (eGFR <30 ml/min), liver dysfunction, pancreatitis, alcohol abusus, malnutrition and decompensated heart failure

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Medical University of Vienna, Department of Surgery, Division of Vascular Surgery

    Vienna, 1090

Other trials in Austria

About this study

Official title: A Prospective Randomized, Double Blind, Placebo-controlled, Safety and Efficacy Study of Metformin as add-on Therapy in Non-diabetic Patients With Abdominal Aortic Aneurysm (MetAAA Study)

A prospective randomized, double blind, placebo-controlled, safety and efficacy study of metformin as add-on therapy in abdominal aortic aneurysm (AAA)

OBJECTIVES Primary Objective

  • To demonstrate treatment efficacy of metformin in AAA in comparison to placebo or active comparator, as measured by growth of the AAA maximum diameter at 12 months Secondary Objectives
  • To asses inflammatory cytokines and parameters of neutrophil activation in AAA in response to metformin treatment by glucose
  • insulin
  • Interleukin-6
  • markers of neutrophil activation (MPO, elastase, NGAL)
Read the detailed description

DESIGN / PHASE Prospective, single-center, randomized, parallel group, double-blind, placebo controlled, phase IIa study STUDY PLANNED DURATION First patient First visit Year 1 1Q

Last patient First visit Year 2 4Q Last patient Last visit Year 3 2Q

CENTER(S)

  • COUNTRY(IES) 1 center in 1 country Austria PATIENTS / GROUPS 170 patients in 2 groups 85 patients per group Randomization ratio 1:1 Stratification for hypertension, age, smoking habit, sex INCLUSION CRITERIA
  • Infrarenal AAA of 3.0-4.9 cm maximum diameter EXCLUSION CRITERIA
  • premenopausal female patients with a pregnancy possibility
  • patients with diabetes
  • indication for surgical AAA repair
  • life expectancy <2 years
  • contraindications for metformin, i.e. severely reduced kidney function (eGFR <30 ml/min), liver dysfunction, pancreatitis, alcohol abuse, malnutrition and decompensated heart failure STUDY PERIODS
  • 1-2 year recruitment
  • 1 year treatment
  • 12 month follow-up INVESTIGATIONAL DRUG

Metformin:

initial dose: 500 mg 1-0-1 target dose: 1000 mg 1-0-1 COMPARATIVE DRUG /CONTROL CONDITION Placebo Initial and target dose: tablets 1-0-1 CONCOMITANT MEDICATION Allowed (standard of care) EFFICACY ENDPOINTS AAA growth (in maximum diameter) over 1 year TOLERABILITY / SAFETY surgery when AAA>5.5 cm for men, > 5 cm for women

Metformin Therapy for AAA Department of Surgery, Division of Vascular Surgery Medical University of Vienna, Austria

ENDPOINTS

adverse drug reactions liver insufficiency sustained reduction of kidney function with glomeral filtration rate <30 mg/dl (upon temporary renal insufficiency, infections, exsiccosis, diarrhea and lactic acidosis, metformin treatment will only be paused)

PHARMACOKINETIC / PHARMACODYNAMIC ENDPOINTS

  • glucose
  • insulin
  • Interleukin-6
  • markers of neutrophil activation (MPO, elastase, NGAL)

QUALITY OF LIFE / PHARMACOECONOMIC ENDPOINTS gastrointestinal discomfort (as assessed in the initial drop-out phase for patient exclusion)

STATISTICAL METHODOLOGY Primary Endpoint AAA growth at 12 months in mm

Null and alternative hypotheses:

H0: Metformin does not reduce AAA growth

H1: Metformin reduces AAA growth from mean 1.7 to 0.4 mm per year Type-I and -II errors:

Significance: 5% Power: 80% 1.7±3.3 mm (mean±SD) without Metformin and 0.4±2.3 mm (mean±SD) with Metformin treatment Sample size calculation 77 per group plus 16 patients drop out Total N= 170 Statistical methodology Main analysis set: per protocol Primary endpoint: analysis of covariance adjusted for baseline AAA diameter Pharmacokinetic endpoints: analysis of covariance adjusted for baseline value. Parametric assumptions will be graphically checked with histograms.

In case of non-normal distributions analysis of covariance will be performed after a logarithmic or rank transformation.

Safety endpoints will be described by cumulative incidence curves

Being tested
Metformin Glucophage 500mg (IR) tablets M90, Placebo Oral Tablet
Keywords
abdominal aortic aneurysm, metformin, non-diabetic, placebo
Medical subject headings
Aortic Aneurysm, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metformin Glucophage 500mg (IR) tablets M90Drug

    Also called Glucophage (Merck)

    oral metformin Glucophage treatment 500 mg daily (2-0-2) for 1 year

  • Placebo Oral TabletDrug

    Also called Placebo (Merck)

    Placebo Oral Tablet M90 treatment twice daily (2-0-2) for 1 year

Study groups in NCT03507413
Study groupRoleWhat they receive
INVESTIGATIONAL DRUGActive comparatororal metformin treatment with 2000Mg daily: Glucophage 500mg Tablet (2-0-2) daily for 1 year
Receives: Drug: Metformin Glucophage 500mg (IR) tablets M90
COMPARATIVE DRUGPlacebo comparatorPlacebo matching M90 Oral Tablet treatment twice daily (2-0-2) for 1 year
Receives: Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AAA growth over 12 months in mm

    AAA maximum diameter in CT scan

    Measured: 12 months

Secondary outcomes (6)

  1. inflammation markers IL-6

    inflammatory cytokines and parameters of neutrophil activation in patient plasma

    Measured: 12 months

  2. glucose markers insulin and glucose

    inflammatory cytokines and parameters of neutrophil activation in patient plasma

    Measured: 12 months

  3. neutrophil markers NGAL

    inflammatory cytokines and parameters of neutrophil activation in patient plasma

    Measured: 12 months

  4. ineutrophil marker MPO

    inflammatory cytokines and parameters of neutrophil activation in patient plasma

    Measured: 12 months

  5. neutrophil marker elastase

    inflammatory cytokines and parameters of neutrophil activation in patient plasma

    Measured: 12 months

  6. AAA thrombus

    volume of AAA thrombus

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2018
  2. Study start26 Sep 2018
  3. Primary completion1 May 2024 (estimated)
  4. Study completion1 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
prospective, randomized, double blind, placebo-controlled, safety and efficacy study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03507413
Sponsor's protocol ID
1479/2017
Acronym
MetAAA
Status last verified
Mar 2024
First submitted
29 Mar 2018
Last updated
28 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • minimale Endnote Formatierung der Refs im Word Dokument probieren!!!

  • Klopf J, Willixhofer R, Ahmadi-Fazel D, Scheuba A, Fuchs L, Sotir A, Wanhainen A, Brostjan C, Neumayer C, Eilenberg W. MetAAA Trial Patients Receiving Metformin Therapy Show Limited Improvement in Quality of Life Compared to AAA Patients with Placebo Intake-A Double-Blind, Randomized, and Placebo-Controlled Trial. Med Sci (Basel). 2025 Nov 15;13(4):273. doi: 10.3390/medsci13040273.

    PubMed 41283274

  • Klopf J, Willixhofer R, Scheuba A, Fuchs L, Sotir A, Wanhainen A, Brostjan C, Neumayer C, Eilenberg W. MetAAA trial patients show superior quality of life compared to patients under regular surveillance for small AAA: a single-center retrospective cohort study. Int J Surg. 2023 Apr 1;109(4):861-869. doi: 10.1097/JS9.0000000000000343.

    PubMed 36999821

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Metformin Glucophage 500mg (IR) tablets M90 in people with Abdominal Aortic Aneurysm, run by Medical University of Vienna at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AAA growth over 12 months in mm (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03507413, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.

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