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Biguanide

Metformin for Infant Brain Injury

Phase 1
Waitlist Available
Led By Brian T Kalish, MD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
HIE Patients: > 35 weeks gestation at time of birth
Preterm Infants: Clinical team anticipates hospitalization at SickKids for at least 1 week after study enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights

Study Summary

This trial will study the safety and feasibility of giving the drug metformin to infants with brain injuries, to see if it can help improve their neural circuit remodeling and recovery.

Who is the study for?
This trial is for infants with brain injuries due to lack of oxygen at birth or premature birth. Eligible preterm infants must be expected to stay in the hospital for a week post-enrollment and born before 32 weeks gestation. HIE patients should be over 35 weeks gestation, under three months old, live within an hour of SickKids Hospital, and have received cooling therapy for HIE.Check my eligibility
What is being tested?
The study is testing the safety and how well metformin can be used in treating infants who suffered from hypoxic ischemic encephalopathy (HIE) or brain injury related to being born too early. It's a phase I trial which means it's the first time they're trying this treatment on babies.See study design
What are the potential side effects?
While specific side effects are not listed here, metformin generally may cause stomach issues like diarrhea or nausea, low blood sugar levels especially in those with risk factors, and potentially vitamin B12 deficiency with long-term use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My baby was born after 35 weeks of pregnancy.
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My preterm infant is expected to stay in the hospital for at least a week after joining the study.
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I have been diagnosed with Hypoxic-Ischemic Encephalopathy (HIE).
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My baby was born before 32 weeks of pregnancy.
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My baby was born prematurely and is between 36-44 weeks in corrected age.
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My infant underwent cooling therapy for HIE treatment.
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I have been diagnosed with hypoxic-ischemic encephalopathy.
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My infant underwent cooling therapy for brain injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients with hypoglycemia (serum glucose <3.3mmol/L)
Secondary outcome measures
Number of patients who complete all study procedures
Number of patients who complete study
Plasma metformin levels

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221
13%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Femoral neck fracture
1%
Squamous cell carcinoma of the tongue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo

Trial Design

4Treatment groups
Experimental Treatment
Group I: Preterm: 20 mg/kgExperimental Treatment1 Intervention
Group II: Preterm: 15 mg/kgExperimental Treatment1 Intervention
Group III: HIE: 25 mg/kgExperimental Treatment1 Intervention
Group IV: HIE: 20 mg/kgExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin Hydrochloride
2016
Completed Phase 4
~1430

Find a Location

Who is running the clinical trial?

University of AlbertaOTHER
886 Previous Clinical Trials
384,777 Total Patients Enrolled
University of WaterlooOTHER
123 Previous Clinical Trials
209,477 Total Patients Enrolled
The Hospital for Sick ChildrenLead Sponsor
686 Previous Clinical Trials
6,944,792 Total Patients Enrolled

Media Library

Metformin Hydrochloride (Biguanide) Clinical Trial Eligibility Overview. Trial Name: NCT05590676 — Phase 1
Hypoxic-Ischemic Encephalopathy Research Study Groups: Preterm: 15 mg/kg, HIE: 25 mg/kg, HIE: 20 mg/kg, Preterm: 20 mg/kg
Hypoxic-Ischemic Encephalopathy Clinical Trial 2023: Metformin Hydrochloride Highlights & Side Effects. Trial Name: NCT05590676 — Phase 1
Metformin Hydrochloride (Biguanide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05590676 — Phase 1

Frequently Asked Questions

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

Is the 25 mg/kg dosage sanctioned by the FDA?

"Based on the limited data surrounding 25 mg/kg, our team has assigned a score of 1 to this potential therapy's safety. This is due to its current status as an early phase trial."

Answered by AI

Are there any openings in this trial's participant pool?

"The clinicaltrial.gov index reflects that this medical study is currently not enrolling participants. Despite the initial posting on January 1st, 2023 and its latest update occurring on November 15th 2022, there are 460 other trials actively recruiting patients at present."

Answered by AI

Who else is applying?

What site did they apply to?
The Hospital for Sick Children
What portion of applicants met pre-screening criteria?
Did not meet criteria
What state do they live in?
Alberta
Recent research and studies
clinicaltrials.govStudy
Metformin Treatment in Infants After Perinatal Brain Injury
Brian Kalish 2023. "Metformin Treatment in Infants After Perinatal Brain Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05590676.
~1 spots leftby Apr 2025
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