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 type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Transfer of drug via breastmilk to infant

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Age groups:
  Term newborn infants (0 – 27 days)

  Adults (18 to < 46 years)
• Estimated number of subjects:
  60

Study design details

• Main study objective:
  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.
• Outcomes:
  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.
• Data analysis plan:
  The quantification of metformin concentrations in human milk and plasma will be made using LC-MS/MS bioanalytical method in accordance with a standard operating procedure. Measurement of metformin levels in milk and plasma will be carried out using a validated method consisting of highperformance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS).