DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes

What Was Tested

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

It had two arms (groups): Metformin (experimental) and Insulin (experimental).

The registry classes the interventions as drug.

More on the Plan

Gestational diabetes mellitus (GDM) is one of the most common medical complications of pregnancy.

Because metformin crosses the placenta, long-term safety data, in particular the risk of childhood obesity, from exposed children are also needed.

To evaluate whether mean child body mass index (BMI) at 2 years of age is higher in the offspring of pregnant individuals randomized to metformin. 2.

Who Took Part

1572 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.

Examples of who could join: Age 18 years or older. Gestational age at randomization between 20 0/7 - 33 6/7 weeks based on project gestational age. GDM diagnosis less than or equal to 33 6/7 weeks based on project gestational age.

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: major structural malformation of the fetus; known fetal aneuploidy based on invasive testing or positive for aneuploidy on cell-free fetal dna screening; contraindication to metformin or insulin, including: history of lactic acidosis, intractable nausea and vomiting, prior documented allergy and/or anaphylaxis.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

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

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2024-08-01 with completion listed for 2029-12.

It ran at 26 sites in United States (26).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Child body mass index (BMI) at 2 years of age (time frame: 2 years of age).

It also tracked 26 secondary outcomes, for example Hypertensive disorder of pregnancy, HDP (maternal), Gestational weight gain (maternal), Mode of delivery (maternal), Obstetric perineal/anal sphincter injuries (maternal), Preterm birth (child) and Requiring mechanical ventilation (child).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 1572 people.

With 1572 participants it is a large trial for this field.

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.