drugset / Trial / NCT06781775
GDM: Insulin with or Without Metformin?
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Metformin | Small molecule | — | — |
| Comparator | Insulin | Protein / enzyme biologic | — | — |