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NCT03651531
Comparison of Insulin Alone to Insulin With Metformin to Treat Gestational Diabetes Mellitus
Phase 3 trial testing Insulin in Gestational Diabetes in 1 participant. Terminated before completion.
30 July 2019
Quick facts
| Lead sponsor | Women and Infants Hospital of Rhode Island |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 3 January 2018 |
| Primary completion | 30 July 2019 |
| Estimated completion | 30 July 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
Conditions studied
- Gestational Diabetes — all drugs for Gestational Diabetes →
Sponsor
Women and Infants Hospital of Rhode Island
Who can join
18 and older, female only, with Gestational Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a prospective, unmasked randomized clinical trial comparing the use of insulin vs combination insulin and metformin for treatment in women diagnosed with gestational diabetes mellitus (GDM). The investigator's hypothesis is that the combination of metformin and insulin will be superior to insulin alone to achieve tight glucose control during pregnancy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03651531
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Insulin
Trials testing the same drug.
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- NCT06781775 — GDM: Insulin with or Without Metformin? · Phase 4 · recruiting
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Other recruiting trials for Gestational Diabetes
Currently open trials in the same condition.
- NCT07171684 — Single vs Multi-Dose Insulin for Glycemic Control (SUGAR) · NA · recruiting
- NCT07314944 — Maternal Sleep and Lifestyle, Metabolic Health, and Perinatal Outcomes in Gestational Diabetes · recruiting
- NCT06571487 — Growth Hormone Resistance of Beta-cells · recruiting
- 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 Women and Infants Hospital of Rhode Island trials
Trials by the same sponsor.
- NCT06930508 — Bringing Medicines for HIV Prevention to a Family Planning Clinic · NA · not yet recruiting
- NCT07437131 — Community-Partnered Doula Support for Neonatal Intensive Care Unit Families · NA · recruiting
- NCT07077707 — Prenatal Genetics Chatbot Trial: Prenatal GENEie · NA · not yet recruiting
- NCT07222852 — Cardiovascular Protection After Preeclampsia With Enalapril · Phase 3 · not yet recruiting
- NCT05861531 — Combined Oral Motor Stimulation and Language on Preterm Infant Feeding · NA · recruiting
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 NCT03651531 (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 Women and Infants Hospital of Rhode Island
- Last refreshed: 24 July 2020
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/NCT03651531.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing