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RECRUITING
NCT06781775
PHASE4

GDM: Insulin with or Without Metformin?

Sponsor: University of Virginia

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2024-12-12

Completion Date

2027-05-01

Last Updated

2025-01-17

Healthy Volunteers

No

Interventions

DRUG

Metformin + Insulin

Pregnant women who have have gestational diabetes and have uncontrolled blood sugar with metformin alone will stay on metformin and add insulin.

DRUG

Insulin

Pregnant women who have have gestational diabetes and have uncontrolled blood sugar with metformin alone will stop on metformin and add insulin.

Locations (1)

University of Virginia

Charlottesville, Virginia, United States