GDM: Insulin with or Without Metformin?

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.

NCT Number	NCT06781775
Lead Sponsor	University of Virginia
Conditions	Gestational Diabetes
Enrollment	130 participants
Start Date	2024-12-12
Primary Completion	2026-05-01 (estimated)
Study Completion	2027-05-01 (estimated)
Updated on ClinicalTrials.gov	2025-01-17