Transfer of metformin into human breast milk and the plasma of breastfeeding children - A low intervention trial withbiobanking of breast milk and plasma in Västra Götalandsregionen and Region Örebro

Phase 1

Recruiting

• Conditions: type 2 diabetes mellitus and gestational diabetes mellitus; MedDRA version: 20.0Level: HLGTClassification code: 10018424Term: Glucose metabolism disorders (incl diabetes mellitus) Class: 10027433; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2022-501693-19-00
• Lead Sponsor: ppsala Universitet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-19
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Breastfeeding women treated with metformin for suspected or diagnosed type 2 diabetes mellitus (T2DM). Only women of 18 years of age and older will be asked for participation. Breastfeeding children of women that have consented to participate in the study. The guardians of the child are asked for participation.

Exclusion Criteria

?Previous participation in the study. Women not able to read and communicate in Swedish, Arabic, Persian or Somali. Premature children. Women with multiple births.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary trial objective is to determine the concentration of metformin in plasma of breast fed infants of lactating women treated for Type 2 Diabetes.;Secondary Objective: 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.;Primary end point(s): The primary endpoint is the concentration of metformin in the breastfeeding child’s plasma 4h after maternal dose intake.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):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.