Trial reportClinical pharmacology and therapeutics2003
Transfer of metformin into human milk.
Trial report in Clinical pharmacology and therapeutics, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06948825 (Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes), which is not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it, 91 citations in OpenAlex.
- Maternal-to-Infant Transfer of Medications for Type 2 Diabetes Mellitus Via Breastmilk: A Systematic Review of Available Evidence and Clinical Guidelines.Clinical pharmacology and therapeutics · 2026Pooled it
- Predicting Drug Transfer Into Human Milk With the Simcyp Simulator: A Contribution From the ConcePTION Project.CPT: pharmacometrics & systems pharmacology · 2025Article
- A tutorial on physiologically based pharmacokinetic approaches in lactation research.CPT: pharmacometrics & systems pharmacology · 2024Article
- Position paper of the Italian Association of Medical Diabetologists (AMD), Italian Society of Diabetology (SID), and the Italian Study Group of Diabetes in pregnancy: Metformin use in pregnancy.Acta diabetologica · 2023Review
- Review
- Generic Workflow to Predict Medicine Concentrations in Human Milk Using Physiologically-Based Pharmacokinetic (PBPK) Modelling-A Contribution from the ConcePTION Project.Pharmaceutics · 2023Article
- Article
- Metformin in aging and aging-related diseases: clinical applications and relevant mechanisms.Theranostics · 2022Review
- Postpartum glucose intolerance: an updated overview.Endocrine · 2018Review
- Influence of Plantago ovata husk (dietary fiber) on the bioavailability and other pharmacokinetic parameters of metformin in diabetic rabbits.BMC complementary and alternative medicine · 2017Article
- Safety considerations with pharmacological treatment of gestational diabetes mellitus.Drug safety · 2015Review
- Use of oral anti-diabetic agents in pregnancy: a pragmatic approach.North American journal of medical sciences · 2015Review
- The Role of Metformin in Metabolic Disturbances during Pregnancy: Polycystic Ovary Syndrome and Gestational Diabetes Mellitus.International journal of reproductive medicine · 2014Review
- Peripartum management of diabetes.Indian journal of endocrinology and metabolism · 2013Review
- Oral Hypoglycemic Agents in pregnancy: An Update.Journal of obstetrics and gynaecology of India · 2013Review
- Gestational diabetes mellitus: Non-insulin management.Indian journal of endocrinology and metabolism · 2011Article
- Clinical pharmacokinetics of metformin.Clinical pharmacokinetics · 2011 · on this mapReview
- Pharmacokinetics of metformin during pregnancy.Drug metabolism and disposition: the biological fate of chemicals · 2010Article
- Dysglycemias in pregnancy: from diagnosis to treatment. Brazilian consensus statement.Diabetology & metabolic syndrome · 2010Article
- Use of hypoglycemic drugs during lactation.Canadian family physician Medecin de famille canadien · 2009Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesOur objectives were to determine the milk-to-plasma ratio of metformin in lactating mothers and to estimate infant exposure.
methodsTwo studies were performed. In study 1, 3 nursing mothers taking metformin were studied throughout a dosing interval at steady state. Blood samples were obtained from 2 suckling infants. In study 2, 5 healthy lactating women who volunteered to express milk after weaning were given metformin, 500 mg, at weaning and were studied for up to 72 hours. In both studies, areas under the plasma and milk concentration-time curves were estimated, and the milk-to-plasma concentration ratio based on area under the concentration-time curve analysis was derived. The infant dose was calculated by standard methods.
resultsIn study 1 the milk-to-plasma concentration ratios based on area under the concentration-time curve analysis were 0.37, 0.50, and 0.71. The estimated "doses" of metformin that would be ingested by the breast-fed infants were 0.18%, 0.20%, and 0.21% of the maternal doses, adjusted for weight. In the breast-fed infants, no metformin was detected (n = 2) or adverse effects noted (n = 3). In study 2, the milk-to-plasma concentration ratio based on area under the concentration-time curve analysis was unable to be calculated for 3 subjects because of the unexpected persistence of metformin in milk beyond the study period. For the 2 subjects studied for 72 hours, the milk-to-plasma concentration ratios based on area under the concentration-time curve analysis were 0.27 and 0.47 and the infant doses were 0.11% and 0.25%. The concentration-time profile for metformin in milk in all subjects was unexpectedly flat.
conclusionsMetformin appears to be "safe" during lactation because of low infant exposure. The unusual concentration-time profile for metformin in milk suggests that the transfer of metformin into milk is not solely dependent on passive diffusion.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.