NCT06781775 GDM: Insulin with or Without Metformin?
| NCT ID | NCT06781775 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Virginia |
| Condition | Gestational Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2024-12-12 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 130 participants in total. It began in 2024-12-12 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06781775 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Gestational Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06781775 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06781775 currently recruiting?
Yes, NCT06781775 is actively recruiting participants. Contact the research team at ajr5y@uvahealth.org for enrollment information.
Where is the NCT06781775 trial being conducted?
This trial is being conducted at Charlottesville, United States.
Who is sponsoring the NCT06781775 clinical trial?
NCT06781775 is sponsored by University of Virginia. The trial plans to enroll 130 participants.
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