Comparing insulin treatment with or without metformin for gestational diabetes
Gestational Diabetes Treatment: Should We Continue Metformin When Starting Insulin? a Randomized Control Trial
PHASE4 · University of Virginia · NCT06781775
This study is testing if pregnant women with gestational diabetes can benefit from continuing metformin along with insulin to see if it helps them and their babies stay healthier.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | University of Virginia (other) |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT06781775 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of continuing metformin alongside insulin therapy in pregnant women diagnosed with gestational diabetes who require insulin for blood sugar control. Participants will be randomly assigned to either continue metformin or discontinue it when insulin is introduced. The study aims to determine if maintaining metformin can lower insulin dosage requirements and enhance both maternal and neonatal health outcomes. This research addresses a gap in current knowledge regarding the optimal management of gestational diabetes when both medications are needed.
Who should consider this trial
Good fit: Ideal candidates are pregnant women diagnosed with gestational diabetes who require insulin therapy after starting metformin.
Not a fit: Patients with allergies to metformin or insulin, severe liver dysfunction, chronic kidney disease, or major fetal anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for gestational diabetes, potentially reducing insulin requirements and enhancing outcomes for mothers and their babies.
How similar studies have performed: This approach has not been extensively studied, making it a novel investigation in the management of gestational diabetes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Pregnant female meeting diagnosis for gestational diabetes requiring medical treatment 4. Ability to take oral medication and be willing to adhere to the metformin regimen 5. Willing to take insulin if needed 6. Willing to take blood sugars 4 times per day \- Exclusion Criteria: * 1\) Metformin allergy or known intolerance, known hypersensitivity to insulin 2) Severe hepatic dysfunction 3) Chronic kidney disease 4) Pregnancy with major fetal anomalies 5) Non-viable pregnancy
Where this trial is running
Charlottesville, Virginia
- University of Virginia — Charlottesville, Virginia, United States (RECRUITING)
Study contacts
- Study coordinator: Amanda R Urban, MS
- Email: ajr5y@uvahealth.org
- Phone: 4344093100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gestational Diabetes