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NCT06781775
GDM: Insulin with or Without Metformin?
Phase 4 trial testing Metformin + Insulin in Gestational Diabetes in 130 participants. Currently enrolling.
1 May 2026
Quick facts
| Lead sponsor | University of Virginia |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 130 |
| Start date | 12 December 2024 |
| Primary completion | 1 May 2026 |
| Estimated completion | 1 May 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Metformin + Insulin — full drug profile →
- Insulin (insulin) — full drug profile →
Conditions studied
- Gestational Diabetes — all drugs for Gestational Diabetes →
Sponsor
University of Virginia
Who can join
Adults 18 to 50, female only, with Gestational Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06781775
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT07336914 — Effect of Conventional vs Intensive Management on Gestational Diabetes and Maternal Fetal Outcomes · NA · recruiting
- NCT07174245 — Pregnancy and Postpartum CGM in GDM · recruiting
Other University of Virginia trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06781775 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Virginia
- Last refreshed: 17 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06781775.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing