What is the mechanism of action of this treatment?

Common treatments for burns include fluid resuscitation, wound care, pain management, and infection prevention. Metformin, a drug typically used for diabetes, is being studied for its potential benefits in burn patients due to its ability to improve glucose metabolism and reduce insulin resistance. This is crucial for burn patients as they often experience a hypermetabolic state and insulin resistance, which can complicate recovery. By improving glucose metabolism, metformin may help mitigate these effects, leading to better clinical outcomes and reduced morbidity and mortality in burn patients.

What side effects are associated with this type of intervention?

Common treatments for burns include wound care, pain management, and infection prevention. For patients with glucose metabolism issues, Metformin is being studied for its potential benefits. Metformin's side effects include gastrointestinal issues such as diarrhea, nausea, and abdominal discomfort. It is generally well-tolerated but can rarely cause lactic acidosis, a serious condition. Other treatments for burns may include antibiotics, which can cause allergic reactions and gastrointestinal disturbances, and pain medications, which can lead to constipation, nausea, and potential dependency.

What prior FDA approvals exist?

The FDA has not specifically approved metformin for the treatment of burns. However, metformin is being studied for its potential to improve clinical outcomes in elderly burn patients by alleviating the complex inflammatory and hypermetabolic responses after burns, which includes improving glucose metabolism and reducing insulin resistance. Currently, there are no FDA-approved drugs specifically targeting these mechanisms in burn treatment.

What other types of research exist?

Promising novel alternatives to Metformin for burn patients in 2024 include GLP-1 receptor agonists such as semaglutide and exenatide, which improve glucose metabolism, reduce insulin resistance, and have anti-inflammatory properties.

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Anti-diabetic drug

Metformin for Burns (MET-ELD Trial)

Phase 2

Waitlist Available

Led By Marc G Jeschke, MD PhD

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥5% total body surface area (TBSA) burn

At least one surgical intervention likely required

Must not have

Clinical contraindication to give metformin

History of lactic acidosis while receiving metformin treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up acute hospitalization up to one year post burn.

Summary

This trial is testing if metformin, a diabetes medication, can help elderly burn patients recover better by controlling blood sugar and reducing inflammation and metabolic stress. Metformin is widely used for diabetes and has shown potential benefits beyond controlling blood sugar, including reducing inflammation.

Who is the study for?

This trial is for elderly patients aged 60-99 with significant burn injuries, who are likely to need surgery and can consent to treatment. They must have a burn covering at least 5% of their body but cannot join if they're critically ill on admission, have severe pre-existing conditions like kidney or liver failure, allergies to metformin, or a history of lactic acidosis with metformin.

What is being tested?

The study tests whether the drug Metformin reduces complications and death rates in elderly patients with burns compared to a placebo. The hypothesis is that Metformin will help manage the intense inflammatory and metabolic reactions following a burn injury.

What are the potential side effects?

Metformin may cause side effects such as digestive issues (nausea, diarrhea), potential vitamin B12 deficiency over time, and very rarely, an increased risk of lactic acidosis—a serious metabolic complication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have burns covering 5% or more of my body.

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I will likely need surgery.

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I am between 60 and 99 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take metformin due to health reasons.

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I have had lactic acidosis from metformin before.

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I have a brain injury from lack of oxygen and am not expected to fully recover.

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I have type II diabetes and need insulin.

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I have severe liver disease.

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My kidney function is severely reduced.

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I chose not to receive treatment because of the severity of my burn injury.

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I am allergic to metformin or insulin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ acute hospitalization up to one year post burn.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~acute hospitalization up to one year post burn.

This trial's timeline: 3 weeks for screening, Varies for treatment, and acute hospitalization up to one year post burn. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Organ function - Alanine transaminase (ALT)

Organ function - Alkaline phosphatase (ALP)

Organ function - Bilirubin

+6 more

Secondary study objectives

Measures of steady-state resting energy expenditure (REE)

Perform oral glucose tolerance test

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221

13%

Nasopharyngitis

10%

Hyperhidrosis

Hunger

Tremor

Asthenia

Hypoglycaemia

Femoral neck fracture

Squamous cell carcinoma of the tongue

100%

80%

60%

40%

20%

Study treatment Arm

Vildagliptin (LAF237)

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MetforminExperimental Treatment1 Intervention

Group II: ControlPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metformin

2006

Completed Phase 4

~2430

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for burns include fluid resuscitation, wound care, pain management, and infection prevention. Metformin, a drug typically used for diabetes, is being studied for its potential benefits in burn patients due to its ability to improve glucose metabolism and reduce insulin resistance. This is crucial for burn patients as they often experience a hypermetabolic state and insulin resistance, which can complicate recovery. By improving glucose metabolism, metformin may help mitigate these effects, leading to better clinical outcomes and reduced morbidity and mortality in burn patients.

Metformin: Focus on Melanoma.5'-AMP-activated protein kinase-activating transcription factor 1 cascade modulates human monocyte-derived macrophages to atheroprotective functions in response to heme or metformin.