GDM: Insulin with or Without Metformin?
Key facts
- Who runs it
- University of Virginia
- Where
- Charlottesville, United StatesSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 130 people, planned
- Started
- 12 Dec 2024
- Expected to end
- 1 May 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Metformin + Insulin
- Insulin
- Record updated
- 17 January 2025
Who can take part
- Age
- 18 years to 50 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Pregnant female meeting diagnosis for gestational diabetes requiring medical treatment
- Ability to take oral medication and be willing to adhere to the metformin regimen
- Willing to take insulin if needed
- Willing to take blood sugars 4 times per day; -
Who cannot take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 50 years old?
Where in United States
- University of VirginiaCharlottesville, United StatesContact: Amanda UrbanTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Metformin + InsulinExisting treatment, for comparison
Pregnant women with gestational diabetes who have uncontrolled blood sugar on metformin alone will be started on insulin and will stay on metformin.
- InsulinExisting treatment, for comparison
Pregnant women with gestational diabetes who have uncontrolled blood sugar on metformin along will be started on insulin and metformin will be discontinued.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Gestational Diabetes Treatment: Should We Continue Metformin When Starting Insulin? a Randomized Control Trial
- Fit questions
- Built from NCT06781775, who can take part
- Record updated
- 17 January 2025