Actively Recruiting
GDM: Insulin with or Without Metformin?
Led by University of Virginia · Updated on 2025-01-17
130
Participants Needed
1
Research Sites
124 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
GDM: Insulin with or Without Metformin?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and be available for the entire study
- Pregnant female diagnosed with gestational diabetes requiring medical treatment
- Ability and willingness to take oral medication (metformin)
- Willingness to take insulin if needed
- Willingness to check blood sugars four times daily
You will not qualify if you...
- Allergy or intolerance to metformin or insulin
- Severe liver dysfunction
- Chronic kidney disease
- Pregnancy with major fetal anomalies
- Non-viable pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
A
Amanda R Urban, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here