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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
Male and Female Veteran aged over 35 and under 89
Maximum Walking Distance (MWD) on the 6-minute walk test (6MWT) of greater than or equal to 50 meters with onset of pain before or at 400 meters without the use of a walker (cane is acceptable) within 6 months of expected randomization date
Must not have
Unable to swallow uncrushed pills
Planned hospital admission, major operation, or lower extremity revascularization to be completed within 12 months after expected randomization date
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month
Awards & highlights
Pivotal 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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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 experience leg pain when I walk.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot swallow pills that are not crushed.
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I am scheduled for a major surgery or hospital stay within the next year.
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I have severe leg pain or non-healing wounds due to poor blood flow.
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I have had liver failure or currently have it.
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I am not pregnant or breastfeeding.
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I have had an amputation above or below the knee.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximal Walking distance on the 6 minute walk test
Secondary study objectives
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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
2014
Completed Phase 1
~150

Find a Location

Who is running the clinical trial?

University of PittsburghOTHER
1,789 Previous Clinical Trials
16,359,423 Total Patients Enrolled
Northwestern UniversityOTHER
1,647 Previous Clinical Trials
958,369 Total Patients Enrolled
2 Trials studying Intermittent Claudication
586 Patients Enrolled for Intermittent Claudication
VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,397 Total Patients Enrolled
1 Trials studying Intermittent Claudication
56 Patients Enrolled for Intermittent Claudication

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
~64 spots leftby Feb 2026
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