Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

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)

ID
Name
1479/2017
Description
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)
Trial arms
Trial start
2018-09-26
Estimated PCD
2024-05-01
Trial end
2024-05-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Metformin Glucophage 500mg (IR) tablets M90
oral metformin Glucophage treatment 500 mg daily (2-0-2) for 1 year
Arms:
INVESTIGATIONAL DRUG
Other names:
Glucophage (Merck)
Placebo Oral Tablet
Placebo Oral Tablet M90 treatment twice daily (2-0-2) for 1 year
Arms:
COMPARATIVE DRUG
Other names:
Placebo (Merck)
Size
170
Primary endpoint
AAA growth over 12 months in mm
12 months
Eligibility criteria
Inclusion Criteria: • Infrarenal AAA of 3-4.9 cm maximum diameter Exclusion Criteria: * 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective, randomized, double blind, placebo-controlled, safety and efficacy study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 170, 'type': 'ESTIMATED'}}
Updated at
2024-03-28

1 organization

2 products

1 indication

Organization
Medical University of Vienna
Product
Metformin Glucophage
Indication
Abdominal Aortic Aneurysm
Product
Placebo