GDM: Insulin with or Without Metformin?

What Was Tested

In this phase 4 trial, researchers set out to test Insulin (regular human).

This will be a randomized trial of patients with gestational diabetes who start hypoglycemic therapy with metformin but eventually require insulin.

It had two arms (groups): Metformin + Insulin (active comparator) and Insulin (active comparator).

Pregnant women with gestational diabetes who have uncontrolled blood sugar on metformin alone will be started on insulin and will stay on metformin.

Pregnant women with gestational diabetes who have uncontrolled blood sugar on metformin along will be started on insulin and metformin will be discontinued.

The registry classes the interventions as drug.

More on the Plan

Normally patients that develop gestational diabetes are treated with either metformin or insulin.

Some need treatment with both.

Many patients ask to start with metformin because it is easy to take and does not require an injection.

Sometimes, patients' blood sugars are not controlled enough on metformin so they need insulin to assist with control of the blood sugars.

Who Took Part

130 planned participants were the target.

It was open to women only aged from 18 years up to 50 years.

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

Examples of who could join: Provision of signed and dated informed consent form. Stated willingness to comply with all study procedures and availability for the duration of the study. Pregnant female meeting diagnosis for gestational diabetes requiring medical treatment. Ability to take oral medication and be willing to adhere to the metformin regimen. Willing to take insulin if needed.

The full record lists 6 inclusion and 1 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2024-12-12 with completion listed for 2026-05-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 130 people.

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

More context: the Insulin (regular human) compound page, all human trials.