Semaglutide for prevention of type 2 diabetes in women with postpartum prediabetes after gestational diabetes: protocol for a Belgian multicentre double-blind randomised placebo-controlled trial

What Was Tested

The paper reports a study of Semaglutide, published as a clinical study.

Women with postpartum pre-diabetes following gestational diabetes mellitus (GDM) are at particularly high risk of developing type 2 diabetes mellitus (T2DM).

The study was approved by the Federal Agency for Medicines and Health Products and the relevant Ethics Committees (2022-502082-22-00) (S66967).

Who Took Part

According to the abstract, 252 women were involved.

PubMed indexes the participants as adults, women only.

Randomisation is stratified by body mass index at early postpartum assessment (<25, 25-29.9 and ≥30 kg/m²).

The primary outcome is the development of T2DM based on the American Diabetes Association criteria.

How the Study Was Run

The researchers set it up as a randomized, double-blind, placebo-controlled and multicenter study.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Neither the women nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Some women received a placebo instead of Semaglutide, giving a reference point.

Running at several centres spread the Semaglutide study over different clinics and patient groups.

SERENA is a Belgian multicentre, double-blind randomised controlled trial conducted in 13 hospitals.

Study visits are scheduled every 6 months and include blood sampling, clinical examinations and completion of self-administered questionnaires.

What Was Measured

Individual participant data will be made available on reasonable request after study completion, database lock, unblinding and publication of the primary results, subject to applicable ethical, legal and data protection requirements.

The subject headings attached to it are Semaglutide, Diabetes Mellitus, Type 2, Diabetes, Gestational, Prediabetic State, Postpartum Period, Belgium and Hypoglycemic Agents.

The authors tagged it with the keywords Diabetes in pregnancy and Life Change Events.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Semaglutide in 252 women.

The publication is from 2026 (BMJ open), a journal based in England.

More context: the Semaglutide compound page, all human trials.