GDM: Insulin with or Without Metformin?
ConditionGestational Diabetes
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorUniversity of Virginia
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Metformin + Insulin
- Insulin
Treatment groups
130 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov