Gestational Diabetes: Insulin with or Without Metformin?

This study is for pregnant women (ages 18-50) who have gestational diabetes (diabetes that develops during pregnancy) and whose blood sugar isn't controlled with metformin alone, so they need to add insulin. Researchers want to find out if continuing to take metformin when you start insulin, or stopping metformin when you start insulin, is better. You would be randomly assigned to one of two groups: either continuing metformin while also taking insulin, or stopping metformin and only taking insulin. The main goal is to see if continuing metformin reduces the amount of insulin needed. The study aims to enroll 130 participants, but its current recruitment status is unclear.

Study design
This is a randomized study comparing two treatment approaches for gestational diabetes, involving approximately 130 participants.
What's involved
You would need to be willing to take oral medication and adhere to a metformin regimen, and be willing to take insulin if needed. You would be followed from enrollment until delivery, for a maximum of 20 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from enrollment into the study until delivery, for a maximum of 20 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06781775

GDM: Insulin with or Without Metformin?

Recruiting
PHASE4Ages 18–50InterventionalTreatment
University of Virginia
~130 participants
Updated 2025-01-17 on ClinicalTrials.gov
What's tested:Metformin + InsulinInsulin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To determine if metformin reduces amount of insulin in patients with gestational diabetes who already require insulin
Measured over From enrollment into study until delivery, maximum 20 weeks
Gestational Diabetes
1 sites across 1 states
Virginia1

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Exclusion

1\) Metformin allergy or known intolerance, known hypersensitivity to insulin 2) Severe hepatic dysfunction 3) Chronic kidney disease 4) Pregnancy with major fetal anomalies 5) Non-viable pregnancy
  • To determine if metformin reduces amount of insulin in patients with gestational diabetes who already require insulinFrom enrollment into study until delivery, maximum 20 weeks

    Insulin dosage (units per kilogram body weight) at last visit prenatal visit