NCT05132439 (MOBILE IC) is a Phase 3 clinical trial of Metformin ER in Intermittent Claudication, sponsored by VA Office of Research and Development.

Who is sponsoring NCT05132439?

NCT05132439 is sponsored by VA Office of Research and Development.

What drugs are being tested in NCT05132439?

Interventions in NCT05132439: Metformin ER, placebo.

What condition does NCT05132439 study?

NCT05132439 studies Intermittent Claudication.

Is NCT05132439 still recruiting?

NCT05132439 is currently recruiting now. Last updated 2 September 2025.

Last reviewed 2025-09-02 · How we verify

NCT05132439: MOBILE IC

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

MetfOrmin BenefIts Lower Extremities With Intermittent Claudication

Recruiting now Phase 3 Last updated 2 September 2025

What this trial tests

Phase 3 trial testing Metformin ER in Intermittent Claudication in 200 participants. Currently enrolling.

Timeline

1 March 2022

Primary endpoint
28 February 2026

28 February 2031

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	200
Start date	1 March 2022
Primary completion	28 February 2026
Estimated completion	28 February 2031
Sites	1 location across United States

Drugs / interventions tested

Metformin ER — full drug profile →
placebo

Conditions studied

Intermittent Claudication — all drugs for Intermittent Claudication →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 35 to 89, any sex, with Intermittent Claudication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Peripheral arterial disease (PAD) affects over 20% of aged adults and is very common among Veterans due significant tobacco use. PAD is due to the progressive blockage of peripheral arteries, predominantly to the legs, and results in intermittent claudication (IC) or recurrent muscle pain with activity secondary to insufficient blood supply. Those with PAD and IC experience a progressive decline in walking and poor quality of life. There is no effective medical treatment for PAD and IC. Metformin is a safe and effective treatment for Type 2 diabetes but it can also reduce inflammation, oxidative stress, and improve energy requirements as well as improve blood flow to the legs. Therefore, the investigators will test the ability of Metformin to improve overall functional status, reduce PAD progression, and reduce systemic inflammation in Veterans suffering from PAD and IC in a randomized, placebo controlled trial: Metformin BenefIts Lower Extremities with Intermittent Claudication (MOBILE IC) Trial. The success of this trial may identify a safe and effective treatment for PAD and IC.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Connecting epigenetics and inflammation in vascular senescence: state of the art, biomarkers and senotherapeutics.
Fraile-Martinez O, De Leon-Oliva D, Boaru DL, De Castro-Martinez P, et al · · 2024 · cited 8× · PMID 38469117 · DOI 10.3389/fgene.2024.1345459
MetfOrmin BenefIts Lower Extremities with Intermittent Claudication (MOBILE IC): randomized clinical trial protocol.
Reitz KM, Althouse AD, Forman DE, Zuckerbraun BS, et al · · 2023 · cited 6× · PMID 36681798 · DOI 10.1186/s12872-023-03047-8

Verify or expand the search:

Other trials of Metformin ER

Trials testing the same drug.

NCT06033131 — PI4 - A Trial Assessing Metformin to Prolong Gestation in Preterm Preeclampsia · Phase 3 · recruiting
NCT03861767 — REMAP Trial for Optimizing Surgical Outcomes at UPMC · Phase 3 · terminated

Other recruiting trials for Intermittent Claudication

Currently open trials in the same condition.

NCT06686121 — Improving Mobility After Revascularization in Peripheral Artery Disease · Phase 3 · recruiting
NCT06657976 — Response to Exercise and Nitric Oxide in PAD · Phase 2 · recruiting
NCT05457738 — Home-based Exercice Therapy for Patients With Intermittent Claudication Using a New Smartphone Application · NA · recruiting
NCT06114732 — Motivating Physical Activity With Behavioural interVention and Electrical Stimulation Remotely in Intermittent Claudicat · NA · recruiting

Other VA Office of Research and Development trials

Trials by the same sponsor.

NCT07456150 — Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care · Phase 1 · not yet recruiting
NCT06746727 — The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veteran · NA · not yet recruiting
NCT07362576 — Perinatal Peer Support for Veterans With Serious Mental Illness · NA · not yet recruiting
NCT06766331 — Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans · NA · not yet recruiting
NCT07397195 — ACT for Veterans With IBD and Mental Health Challenges · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05132439 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 2 September 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05132439.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing