Semaglutide for the Treatment of Glucose Intolerance in Women With Prior Gestational Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Semaglutide.

Moreover, women with a history of GDM progress more rapidly to T2DM compared to women with similarly elevated glucose levels.

It had two arms (groups): semaglutide (active comparator) and placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Intervention and comparison: Belgian multi-centric double blind RCT with 13 centers to compare semaglutide (once weekly) with placebo in women with a recent history of GDM and glucose intolerance \[impaired fasting glycaemia (IFG) and/or impaired glucose tolerance (IGT)\] 6weeks - 12 months postpartum.

Participants will be 1/1 randomized to semaglutide or placebo on a background of lifestyle measures.

Participants will be followed-up for 3 years.

Randomization will be stratified according to BMI at the early postpartum visit (\<25; 25-29.9 and ≥30Kg/m²).

Who Took Part

252 planned participants were the target.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2023-09-14 with completion listed for 2030-03.

It ran at 13 sites in Belgium (13).

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Development of T2DM (time frame: by 160 weeks).

It also tracked 33 secondary outcomes, for example Need for glucose-lowering (rescue) therapy, Frequency of prediabetes based on FPG, OGTT, and/or HbA1c, Regression to normoglycaemia, Change in body weight, BMI and Waist circumference.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 252 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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