Metformin for Burns

(MET-ELD Trial)

Not yet recruiting at 1 trial location

Overseen By Marc G Jeschke, MD PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sunnybrook Health Sciences Centre

Must not be taking: Insulin

Disqualifiers: Renal failure, Severe liver disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1-4 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether metformin, a common diabetes medication, can improve recovery in elderly patients with severe burns. Researchers aim to determine if metformin can reduce the body's intense inflammatory and metabolic responses after a burn, potentially lowering death rates and improving health outcomes. Participants must be 60 years or older, have significant burns covering at least 5% of their body, and have been admitted to a burn center within five days of injury. As a Phase 2 trial, this research focuses on measuring metformin's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have insulin-dependent type II diabetes or a clinical contraindication to metformin, you may not be eligible to participate.

Is there any evidence suggesting that metformin is likely to be safe for humans?

Research has shown that metformin is usually safe for use. The FDA has approved this medication for treating type 2 diabetes, indicating its safety for many individuals. However, the situation may differ for burn patients. A recent study found that burn patients with low blood sugar (hypoglycemia) face a much higher risk of death. Therefore, monitoring blood sugar levels when using metformin in these patients is important. Generally, metformin's side effects are mild, such as an upset stomach or diarrhea. For burn patients, though, careful monitoring of blood sugar levels is crucial to ensure safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for burns?

Unlike the standard burn treatments that often focus on wound care and pain management, Metformin is unique because it targets the body's metabolic response to burn injuries. Originally a diabetes medication, Metformin is being explored for its potential to reduce inflammation and improve healing by modulating cellular processes. Researchers are excited about Metformin for burns because it offers a novel approach that could enhance recovery and reduce complications, potentially transforming how burn patients are treated.

What evidence suggests that metformin might be an effective treatment for burns?

Research shows that metformin, which participants in this trial may receive, can benefit elderly burn patients. Studies have found that metformin lowers the risk of death and complications by controlling blood sugar and boosting overall health. One study discovered that patients taking metformin needed fewer surgeries and had shorter hospital stays than those who didn't take it. This finding suggests that metformin might help manage the body's reaction to burns, particularly the increased metabolism that can slow recovery. Overall, metformin appears promising in improving survival and recovery for elderly burn patients. ^{5 6 7 8 9}

Who Is on the Research Team?

Marc G Jeschke, MD PhD

Principal Investigator

Hamilton Health Sciences Corporation

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I was admitted to a burn center within 5 days after getting burned.

Provide written informed consent

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

Exclusion Criteria

I cannot take metformin due to health reasons.

I have had lactic acidosis from metformin before.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive metformin or placebo and are monitored for episodes of sepsis, organ function, and metabolic response

1-4 months

Daily assessments during hospital stay

Follow-up

Participants are monitored for mortality and organ function post-discharge

Up to 1 year post burn

What Are the Treatments Tested in This Trial?

Interventions

• Metformin

Trial Overview 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.

How Is the Trial Designed?

Group I: Metformin Experimental Treatment 1 Intervention

Group II: Control Placebo Group 1 Intervention

Metformin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Glucophage for:

• Type 2 diabetes

Approved in United States as Glucophage for:

• Type 2 diabetes

Approved in Canada as Glucophage for:

• Type 2 diabetes

Approved in Japan as Glucophage for:

• Type 2 diabetes

Approved in China as Glucophage for:

• Type 2 diabetes

Approved in Switzerland as Glucophage for:

• Type 2 diabetes

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Hamilton Health Sciences Corporation

Lead Sponsor

Trials

380

Recruited

345,000+

Published Research Related to This Trial

Dapagliflozin, a selective SGLT2 inhibitor, has been shown to improve glycaemic control in adults with type 1 diabetes (T1D) and a BMI of ≥27 kg/m2, allowing for reduced insulin doses and weight loss over 24 weeks, with effects maintained up to 52 weeks.

The drug has a favorable safety profile, with a lower incidence of diabetic ketoacidosis in patients with higher BMI compared to the overall population, making it a promising adjunct treatment for those not achieving adequate control with insulin alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dapagliflozin: A Review in Type 1 Diabetes. Paik, J., Blair, HA.[2021]

In a phase II clinical trial involving 81 patients with recurrent or refractory glioblastoma, the combination of metformin and low-dose temozolomide was well tolerated but did not show a significant clinical benefit in terms of progression-free survival or overall survival compared to the control group receiving placebo and temozolomide.

The median overall survival was 17.22 months for the metformin group versus 7.69 months for the control group, but this difference was not statistically significant, indicating that metformin may not improve outcomes in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of metformin plus low-dose temozolomide in patients with recurrent or refractory glioblastoma: a randomized, prospective, multicenter, double-blind, controlled, phase 2 trial (KNOG-1501 study). Yoon, WS., Chang, JH., Kim, JH., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12506066/

Beyond diabetes: harnessing the power of metformin in burn ... Nonetheless, the available data suggest that metformin holds significant potential as an adjunct therapy in the comprehensive management of burn ...

2. nature.com nature.com/articles/s41514-025-00224-1

Metformin administration improves adverse outcomes in ... This study assesses the safety and efficacy of metformin administration in older adult burn patients, a rapidly growing demographic with substantially poorer ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7859867/

Glucose Control in Severely Burned Patients Using ... In terms of clinical outcome data, we found that the number of surgeries, length of stay, and length of stay normalized per percent burn were similar between ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0305417924001670

Metformin is associated with reduced risk of mortality and ... The results of this study demonstrate a significant reduction in morbidity and mortality amongst burn patients who were given metformin for glycemic control ...

5. physiciansweekly.com physiciansweekly.com/post/why-metformin-may-redefine-burn-metabolic-care

Why Metformin May Redefine Burn Metabolic Care Incorporating metformin in burn metabolic care may help control hyperglycemia and broader metabolic dysfunction linked to poor outcomes.

6. cdn.stemcell.com cdn.stemcell.com/media/files/msds/DX21194-SDS_2_0_0.pdf

SAFETY DATA SHEET Unknown acute toxicity. 0 % of the mixture consists of ingredient(s) of unknown toxicity. 0 % of the mixture consists of ingredient(s) of ...

7. imgcdn.mckesson.com imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_9BRMY_00087607005_GLUCOPHAGE_TAB.pdf

Safety Data Sheet Extinguishing Media. Suitable extinguishing media: Dry chemical, Water spray, Foam. Unsuitable extinguishing media: Do NOT use water jet. Page 3. GLUCOPHAGE® ( ...

8. spectrumchemical.com spectrumchemical.com/media/sds/M1566_AGHS.pdf?srsltid=AfmBOoqLTEmYMuoETz8E_L4hAdpisOGRkPLpSSTgE2U4PBxPXqmAF5K8

SAFETY DATA SHEET METFORMIN HYDROCHLORIDE, BP ... No information available. Hazardous combustion products. Burns rapidly, releasing dense, white, irritating fumes.

9. merck.com merck.com/docs/product/safety-data-sheets/hh-sds/Ertugliflozin%20and%20Metformin%20Formulation_HH_GB_6N.pdf

Ertugliflozin / Metformin Formulation H314. : Causes severe skin burns and eye damage. H318. : Causes ... SDS - Safety Data Sheet;. SVHC - Substance of very high concern; TCSI ...