GDM: Insulin with or Without Metformin?

Recruiting now · Phase 4

Conditions studied: Gestational Diabetes

In brief

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.

Key facts

Study ID

NCT06781775

Run by

University of Virginia

People needed

130

Starts

2024-12-12

Expected to finish

2027-05-01

Last updated by the study team

2025-01-17

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Willing to take blood sugars 4 times per day

You may not qualify if…

• 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

Where it is running

• University of Virginia — Charlottesville, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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