DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOhio State University
About this trial
This is a non-inferiority patient-centered and pragmatic comparative-effectiveness pregnancy randomized controlled trial (RCT) with postpartum maternal and child follow-up through 2 years of 1,572 individuals with gestational diabetes mellitus (GDM) randomized to oral metformin versus injectable insulin.
This study will determine if metformin is not inferior to insulin in reducing adverse pregnancy outcomes, is comparably safe for exposed individuals and children, and if patient-reported factors, including facilitators of and barriers to use, differ between metformin and insulin. A total of 1,572 pregnant individuals with GDM who need pharmacotherapy will be recruited at 20 U.S. sites using consistent treatment criteria to metformin versus insulin. Participants and their children will be followed through delivery to two years postpartum.
Eligibility criteria
Qualifiers
Singleton gestation. Twin reduction to singleton, either spontaneously or therapeutically, is eligible if it occurred before 14 weeks gestational age.
Age 18 years or older
Gestational age at randomization between 20 0/7 - 33 6/7 weeks based on project gestational age.
GDM diagnosis less than or equal to 33 6/7 weeks based on project gestational age.
Disqualifiers
Renal disease (serum creatinine >1.3 mg/dL) due to the potential impact of metformin on renal function.
Major structural malformation of the fetus.
Known fetal aneuploidy based on invasive testing or positive for aneuploidy on cell-free fetal DNA screening.
Contraindication to metformin or insulin, including: history of lactic acidosis, intractable nausea and vomiting, prior documented allergy and/or anaphylaxis.
Trial design
Treatments tested in this trial
- Metformin
- Insulin
Treatment groups
1,572 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ohio State University
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
The George Washington University Biostatistics Center
Collaborator
Source ClinicalTrials.gov