drugset / Trial / NCT06781775

GDM: Insulin with or Without Metformin?

NCT06781775

Phase 4 Recruiting 130 enrolled University of Virginia
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2024-12-12
Primary completion
2026-05-01
Completion
2027-05-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metformin Small molecule
Comparator Insulin Protein / enzyme biologic

Indications