Ongoing Clinical Trials Related to Exposure Via Breast Milk
Currently, there is 1 ongoing clinical trial investigating exposure via breast milk. This trial focuses on understanding how medications taken by breastfeeding mothers transfer into breast milk and affect their infants. The study is being conducted in Sweden and involves women with diabetes who are taking metformin while breastfeeding.
Clinical trial locations
Study on Metformin Transfer into Breast Milk and Infant Plasma in Breastfeeding Women with Type 2 or Gestational Diabetes
This clinical trial is investigating how the diabetes medication metformin transfers into breast milk and the blood of breastfed infants. The study aims to provide important safety information for mothers who need to take this medication while breastfeeding.
Who can participate:
- Women who are currently breastfeeding
- Women who are at least 18 years old
- Women being treated with metformin for type 2 diabetes or gestational diabetes
- Their breastfeeding children, with guardian consent
Who cannot participate:
- Men (this study is specifically for women)
- Women who are not breastfeeding
- Women who do not have type 2 diabetes or gestational diabetes
- Women outside the specified age range
- Vulnerable populations not included in the study criteria
What the trial involves:
The study focuses on measuring how much metformin passes into breast milk and subsequently into the infant’s bloodstream. Participants will continue taking their prescribed metformin as usual for their diabetes treatment. The research team will collect breast milk samples at specific times: immediately before taking metformin and 3 hours after taking the medication. Blood samples will also be collected from the mother at 0, 2, and 3 hours after taking metformin, and from the breastfeeding child at 4 hours after the mother’s dose.
All collected samples will be stored for future research purposes through a process called biobanking. The study is designed to be low-risk and aims to gather valuable information about the safety of using metformin while breastfeeding.
Investigational medication:
Metformin is a well-established medication commonly used as a first-line treatment for type 2 diabetes and gestational diabetes. It works by reducing the amount of sugar produced by the liver and improving how the body responds to insulin. Metformin belongs to a class of drugs called biguanides and is typically taken orally as a tablet. This study is not testing whether metformin is effective for treating diabetes, but rather investigating how much of the medication is transferred to breastfed infants.
Summary
This single ongoing trial represents an important area of research focused on medication safety during breastfeeding. The study is being conducted in Sweden and addresses a significant gap in knowledge about metformin exposure through breast milk. Understanding how medications transfer into breast milk and affect infants is crucial for healthcare providers and mothers who need to continue diabetes treatment while breastfeeding. The research focuses specifically on metformin, one of the most commonly prescribed medications for diabetes management, making the findings potentially relevant to many breastfeeding mothers worldwide. The study is expected to conclude by December 31, 2025.