Treatment to Regress to Normoglycemia in Women with a Recent History of GDM

What Was Tested

The trial (phase 4) is built around Semaglutide.

It had two arms (groups): Semaglutide Pen Injector (Ozempic) (experimental) and Placebo (sham comparator).

Weekly injections of placebo for 8 months total.

The registry classes the interventions as drug.

More on the Plan

The diagnosis of gestational diabetes mellitus (GDM) during pregnancy identifies young women with abnormalities in pancreatic beta cell function that worsen over time, leading to diabetes.

In many cases, it is possible to reverse diabetes by losing weight in the early stages before permanent, systemic damage occurs.

Who Took Part

Enrollment: 102 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 18 - 45 years old (inclusive). History of gestational diabetes in most recent pregnancy. 6 months - 10 years postpartum. BMI ≥ 25 kg/m2. Use of long-acting reversible contraception or bilateral tubal ligation.

The full record lists 12 inclusion and 18 exclusion criteria; among the exclusions: body weight \> 350lb; pregnant or the intention of becoming pregnant or not using adequate contraceptive measures; breastfeeding within 3 months of screening visit 1.

How the Study Was Run

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

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

The Semaglutide group and the comparison group ran side by side rather than switching.

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

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

It started in 2022-01-13 with completion listed for 2026-01-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Regression to normoglycemia.

It also tracked 2 secondary outcomes, for example Change in HbA1c and Change in body weight.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 102 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.