Transfer of metformin into human breast milk and the plasma of breastfeeding children - A low intervention trial with biobanking of breast milk and plasma in Västra Götalandsregionen och i Region Örebro (Metformin Breast feeding study)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/105191
• EU PAS number:
  EUPAS105190
• Study ID:
  105191
• Official title and acronym:
  Transfer of metformin into human breast milk and the plasma of breastfeeding children - A low intervention trial with biobanking of breast milk and plasma in Västra Götalandsregionen och i Region Örebro (Metformin Breast feeding study)
• DARWIN EU® study:
  No
• Study countries:
  Sweden
• Study description:
  The study has a low intervention trial design in the sense that breast milk and blood will be collected merely to study excretion of metformin into breastmilk and transferal to her child. Participation in the study will not decide or in any other way interfere with patients’ treatment as prescribed by their physician. Only patients that already have been assigned treatment with metformin by their physician will be approached and asked for participation. Breast milk will be collected at two times during the visit, using an electric breast milk pump. Venous blood will be collected from the woman and from the infant. After centrifugation, plasma samples and breast milk sample will be aliquotaded, frozen at -80 degrees and stored at Biobank Väst and Örebro Biobank, respectively. When all samples have been collected, they will be transferred to Uppsala Biobank. Samples will be analysed for pharmacokinetic properties using mass spectrometry at the UDOPP Platform (Uppsala Drug Optimization and Pharmaceutical Profiling) at the Department of Pharmacy, Uppsala University. The primary objective is to determine the concentration of metformin in plasma of breast-fed infants of lactating women treated for T2D. A secondary objective is to determine the milk-to-plasma ratio in the women and, based on absolute infant dose (AID) and dosage of mother, the relative infant dose will be calculated. The primary endpoint is the concentration of metformin in the breastfeeding child’s plasma 4h after maternal dose intake. The secondary endpoint is the concentration of metformin in breast milk at 0h (trough) and 2h after intake. The tertiary endpoint is the maternal plasma concentration of metformin at 0h (trough) and 2h after intake. The measure of drug levels in plasma and milk, will be carried out using a validated method consisting of high-performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS).
• Study status:
  Ongoing

Research institutions and networks

Institutions

Uppsala University

Department of Obstetrics, Östra Sjukhuset Göteborg, Department of Obstetrics and Gynecology, University Hospital Örebro

Study timelines

Date when funding contract was signed

Actual: 10/04/2019

Study start date

Planned: 15/01/2024

Actual: 01/06/2023

Data analysis start date

Planned: 01/09/2024

Date of final study report

Planned: 01/12/2024

Sources of funding

EU institutional research programme

More details on funding

IMI-2JU, Grant nr. 821520

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

Approval ny the Swedish Ethical Review Authority, Number: 2023-02549-01.