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Biguanide

Metformin for Intermittent Claudication (MOBILE IC Trial)

Phase 3
Recruiting
Led By Edith I. Tzeng, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Medically stable, optimal medical therapy for more than 3 months prior to randomization, including statin and anti-platelet therapy, blood pressure control, smoking cessation, and physical activity counseling
Male and Female Veteran aged over 35 and under 89
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month
Awards & highlights

MOBILE IC Trial Summary

This trial is testing whether Metformin can improve the symptoms of peripheral artery disease and intermittent claudication, which are caused by blockages in the peripheral arteries.

Who is the study for?
This trial is for Veterans over 35 with Peripheral Artery Disease (PAD) and Intermittent Claudication, who have been on optimal medical therapy including lifestyle changes. They must be able to walk a certain distance without severe pain or assistance other than a cane. It's not for those with diabetes, severe kidney disease, recent major surgeries, or conditions limiting walking ability.Check my eligibility
What is being tested?
The MOBILE IC Trial is testing if Metformin ER can improve walking ability and quality of life in PAD patients by reducing inflammation and improving blood flow. Participants will either receive Metformin ER or a placebo in this randomized controlled study.See study design
What are the potential side effects?
Metformin may cause digestive issues like nausea or diarrhea, potential vitamin B12 deficiency with long-term use, and rarely lactic acidosis—a serious condition where the body produces too much lactic acid.

MOBILE IC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've been on stable heart and blood vessel health treatment for over 3 months, including lifestyle changes.
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I am a veteran aged between 35 and 89.
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I can walk more than 50 meters but not over 400 meters without severe pain, using only a cane if needed.
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I have been diagnosed with PAD, confirmed by tests within the last 6 months.
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I experience leg pain when I walk.
Select...
My doctor has tried to give me the best treatment I can handle before joining this trial.

MOBILE IC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximal Walking distance on the 6 minute walk test
Secondary outcome measures
6 minute walk test
Ankle brachial index
Ankle brachial index and pulse volume recording
+7 more

Side effects data

From 2014 Phase 1 trial • 68 Patients • NCT02084082
10%
Headache
8%
Diarrhoea
4%
Rhinitis
4%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
FDC 1000 Fasted
L+M 1000 Fed
FDC 1000 Fed
L+M 1000 Fasted

MOBILE IC Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Metformin ER 1000mgExperimental Treatment1 Intervention
daily by mouth
Group II: Matching placeboPlacebo Group1 Intervention
daily by mouth
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin ER
2019
Completed Phase 3
~450

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,607 Previous Clinical Trials
3,305,835 Total Patients Enrolled
1 Trials studying Intermittent Claudication
56 Patients Enrolled for Intermittent Claudication
University of PittsburghOTHER
1,716 Previous Clinical Trials
16,346,254 Total Patients Enrolled
San Francisco Veterans Affairs Medical CenterFED
48 Previous Clinical Trials
210,563 Total Patients Enrolled

Media Library

Metformin ER (Biguanide) Clinical Trial Eligibility Overview. Trial Name: NCT05132439 — Phase 3
Intermittent Claudication Research Study Groups: Matching placebo, Metformin ER 1000mg
Intermittent Claudication Clinical Trial 2023: Metformin ER Highlights & Side Effects. Trial Name: NCT05132439 — Phase 3
Metformin ER (Biguanide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05132439 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any detrimental effects to taking Metformin ER?

"Metformin ER is a Phase 3 trial medication, meaning that there is both efficacy and safety data available. Power rates the safety of this drug as a 3."

Answered by AI

What other scientific papers have been published about Metformin ER?

"Out of the 45 Phase 3 trials for Metformin ER, 180 are currently active. Although Pittsburgh, Pennsylvania has a high concentration of these studies, there are actually 1952 locations conducting research on this medication."

Answered by AI

How many individuals are being given this medication as part of the research trial?

"That is correct, the online information indicates that this study is looking for volunteers. The trial was initially posted on March 1st, 2022 and updated most recently on July 11th, 2022. They are hoping to enroll 200 patients from a single site."

Answered by AI

Are people of all ages being accepted for this study?

"The ages of eligible candidates for this clinical trial range from 35 years old to 89 years young."

Answered by AI

For what health issues is Metformin ER most commonly prescribed?

"Metformin ER is mostly used to help people exercise, but it can also be employed as a treatment for type 1 diabetes mellitus, diabetic ketoacidosis, and polycystic ovary syndrome."

Answered by AI

Are we able to sign up for this research project?

"The trial is presently recruiting patients, with the original posting date on clinicaltrials.gov being March 1st, 2022 and the most recent update occurring on July 11th of the same year."

Answered by AI

What are the entrance requirements for this clinical trial?

"Intermittent claudication and an age between 35 and 89 are the inclusion criteria for this trial. The goal is to have 200 individuals enrolled in the study."

Answered by AI
~98 spots leftby Feb 2026