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GDM: Insulin with or Without Metformin?

Gestational Diabetes Treatment: Should We Continue Metformin When Starting Insulin? a Randomized Control Trial

Who can join

Ages 18 to 50 · Women

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Pregnant female meeting diagnosis for gestational diabetes requiring medical treatment
4. Ability to take oral medication and be willing to adhere to the metformin regimen
5. Willing to take insulin if needed
6. Willing to take blood sugars 4 times per day

   \-

   Exclusion Criteria:
   * 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

About the study

This will be a randomized trial of patients with gestational diabetes who start hypoglycemic therapy with metformin but eventually require insulin. It will examine whether continuing metformin when adding insulin versus discontinuing metformin when insulin is added is beneficial. The investigators hypothesize that continuing metformin will reduce the needed insulin dosage and improve maternal and neonatal outcomes in these patients.

What is being tested

• Metformin + Insulin (drug)
• Insulin (drug)

Sponsor: University of Virginia · Participants: 130 · Started: Dec 12, 2024

Contact the study team

• Amanda R Urban, MS · Phone: 4344093100

Official record on ClinicalTrials.gov — NCT06781775

Locations in the U.S.

Conditions

• Gestational Diabetes

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.