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 and Region Örebro

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501693-19-00

Enrollment

Registered

2024-01-23

Start date

2024-03-06

Completion date

2025-12-31

Last updated

2024-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes mellitus and gestational diabetes mellitus

Brief summary

The primary endpoint is the concentration of metformin in the breastfeeding child’s plasma 4h after maternal dose intake.

Detailed description

The secondary endpoint is the concentration of metformin in breast milk at 0h (through) and 3h after intake. The tertiary endpoint is the maternal plasma concentration of metformin at 0h (through), 2h and 3h after intake.

Interventions

DRUGMETFORMIN

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the concentration of metformin in the breastfeeding child’s plasma 4h after maternal dose intake.	—

Secondary

Measure	Time frame
The secondary endpoint is the concentration of metformin in breast milk at 0h (through) and 3h after intake. The tertiary endpoint is the maternal plasma concentration of metformin at 0h (through), 2h and 3h after intake.	—

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026