An Early Phase 1 interventional study of Metformin (open-label) and Metformin (open-label) in Bronchopulmonary Dysplasia (BPD), sponsored by Medical College of Wisconsin. Recruiting at 1 site in United States. Open to participants aged 7 Days to 6 Months. Per ClinicalTrials.gov, last updated 2026-01-26.
Sponsored by Medical College of Wisconsin · Early Phase 1, Interventional, and Basic science
The overall objective of this study is to investigate the role of metformin in decreasing lung injury and promoting lung growth in premature infants. There are two phases to this pilot study. For Phase 0, the goal is to investigate the safety and tolerance of oral metformin in premature who have been diagnosed with bronchopulmonary dysplasia (BPD) at 36-44 weeks gestation. For Phase 1, the goal is to investigate metformin safety and tolerance in extremely premature infants who are 7-30 days old who have an increased risk of BPD. The main questions it aims to answer are:
In Phase 0, there are four groups with different doses of metformin, starting at 5mg/kg/day to a maximum of 25mg/kg/day. Participants will take oral metformin twice a day for 3, 7 or 14 days, depending on which group they are in. In Phase 1, there are four groups with different doses of metformin, starting at 15mg/kg/day to a maximum of 25mg/kg/day. Participants will take oral metformin once a day for 3, 7, or 14 days, depending on what group they are in.
339 studies on the registry are indexed under Bronchopulmonary Dysplasia; 80 are open to participants now.
This study's planned enrollment of 40 is below the median of 70 across 228 interventional studies indexed under Bronchopulmonary Dysplasia.
Browse Bronchopulmonary Dysplasia studies →Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria Phase 0:
Inclusion Criteria Phase 1:
Exclusion Criteria:
5mg/kg/day in two divided doses for three days
Drug: Metformin (open-label)
10mg/kg/day in two divided doses for three days
Drug: Metformin (open-label)
20mg/kg/day in two divided doses for seven days
Drug: Metformin (open-label)
25mg/kg/day in two divided doses for 14 days
Drug: Metformin (open-label)
15mg/kg/day in a single daily dose for three days
Drug: Metformin (open-label)
25mg/kg/day in a single daily dose for three days
Drug: Metformin (open-label)
10mg/kg/day in a single daily dose for three days
Drug: Metformin (open-label)
10-25mg/kg/day (dose selected from either Cohort 2 or 3)
Drug: Metformin (open-label)
10-25mg/kg/day (dose selected from either Cohort 2 or 3)
Drug: Metformin (open-label)
Enteric metformin 5mg/kg/day in two divided doses will be given for three days to two subjects
Enteric metformin 10mg/kg/day in two divided doses will be given for three days to two subjects.
Enteric metformin 20mg/kg/day in two divided doses will be given for seven days to three subjects.
Enteric metformin 25mg/kg/day in two divided doses will be given for 14 days to three subjects.
Enteric metformin 15mg/kg/day in a single daily dose will be given for three days to 3-6 subjects. Depending on tolerance, the next Cohort will increase to 25mg/kg/day (Cohort 2) or decrease to 10mg/kg/day (Cohort 3)
Enteric metformin 25mg/kg/day in a single daily dose will be given for three days to 3-6 subjects. Depending on tolerance, either 25mg/kg/day or 15mg/kg/day will be dose selected for the next Cohort (Cohort 4)
Enteric metformin 10mg/kg/day in a single daily dose will be given for three days to 3-6 subjects. Depending on tolerance, either 10mg/kg/day dose selected for the next Cohort (Cohort 4) or the study will be stopped due to excessive toxicity.
The dose for this cohort will be selected from either Cohort 2 or 3 based on tolerance. Enteric metformin 10-25mg/kg/day in a single daily dose will be given for seven days to 6 subjects.
The dose for this cohort will be the same as Cohort 4. Enteric metformin 10-25mg/kg/day in a single daily dose will be given for 14 days to 6 subjects.
Number of participants who tolerate metformin
Number of subjects who receive enteral doses of metformin and complete the study days without an adverse event while continuing enteral feedings
Time frame: 14 days after administration of the first dose of metformin
Number of participants with treatment-related adverse events
Number of participants who develop hypoglycemia defined as blood glucose value \<50
Time frame: 14 days after administration of the first dose of metformin
Number of participants with treatment-related metabolic acidosis
Number of subjects who develop lactic acid levels \> 5mmol/L
Time frame: 14 days after administration of the first dose of metformin
Number of subjects with treatment-related feeding problems
Number of subjects who require a decrease in enteral feeding volume by \>50% from baseline
Time frame: 14 days after administration of the first dose of metformin
Number of subjects who require dose adjustments of metformin
Number of subjects who need decreases in dose or discontinuation of metformin due to hepatic or renal dysfunction
Time frame: 14 days after administration of the first dose of metformin
Number of subjects with respiratory deterioration
Number of subjects who develop pneumonia and increases in oxygen concentration and ventilator support during the study
Time frame: 14 days after administration of the first dose of metformin
Number of subjects who complete pharmacokinetic evaluation of metformin
Number of subjects who have at least one metformin concentration in blood measured at 1, 4 and 12 hours after an enteric dose
Time frame: 14 days after administration of the first dose of metformin
Pharmacokinetic analysis of metformin
Area under the curve of Plasma Concentration Versus Time (AUC) of metformin over a time frame of 1, 4 and 12 hours after an enteric dose of metformin.
Time frame: 14 days after administration of the first dose of metformin
Number of subjects who complete the treatment protocol
Number of subjects who complete the study doses of enteric metformin
Time frame: 14 days after administration of the first dose of metformin
Incidence of bronchopulmonary dysplasia
Number of subjects who are diagnosed with bronchopulmonary dysplasia
Time frame: 14 days after administration of the first dose of metformin
Incidence of necrotizing enterocolitis
Number of subjects who are diagnosed with necrotizing enterocolitis
Time frame: 14 days after administration of the first dose of metformin
Incidence of retinopathy of prematurity
Number of subjects who are diagnosed with retinopathy of prematurity
Time frame: 14 days after administration of the first dose of metformin
Incidence of intraventricular hemorrhage
Number of subjects who are diagnosed with intraventricular hemorrhage
Time frame: 14 days after administration of the first dose of metformin
Incidence of patent ductus arteriosus
Number of subjects who are diagnosed with patent ductus arteriosus
Time frame: 14 days after administration of the first dose of metformin
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Plan to share: No — Since this is a small phase 0 and phase 1 study with enrollment of 4-30 infants from one site only in a short time frame, we are concerned about potential for unmasking the identification of individual identification from the sharing of individual patient data.
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Medical College of Wisconsin