DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes

Recruiting now · Phase 4

Conditions studied: Gestational Diabetes Mellitus, Pregnancy, High Risk

In brief

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.

Key facts

Study ID

NCT06445946

Run by

Ohio State University

People needed

1572

Starts

2024-08-01

Expected to finish

2030-12-01

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Requires medication for glucose control defined as ≥ 30% elevated glucose values (either fasting or postprandial or both) prior to randomization per determination of the provider or documented in the medical record.
• Patient willingness and ability to attend 2-year follow-up visit.

You may not qualify if…

• 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.
• For individuals with GDM diagnosed <20 0/7 weeks, documented A1c ≥>6.5% within prior 6 months.
• Pregestational diabetes documented in the medical record or prior A1c>= 6.5%
• Fasting hyperglycemia >115 mg/dl for ≥ 50% of fasting glucose values in the past week (due to the high risk of metformin failure with fasting hyperglycemia).
• Enrolled in a trial that influences primary study outcomes (composite neonatal outcome at delivery or childhood body mass index at 2 years).
• Prenatal care or delivery planned at a location where access to the complete electronic medical record will not be available to research staff.
• Language barrier (appropriate translation resources unavailable at the site)
• Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.

Where it is running

• Eastern Virginia Medical School - Old Dominion University — Norfolk, Virginia, United States (enrolling)
• Cedars Sinai Medical Center — Los Angeles, California, United States (enrolling)
• University of California San Francisco — San Francisco, California, United States (enrolling)
• Brown University — Providence, Rhode Island, United States (enrolling)
• University of South Carolina Greenville — Greenville, South Carolina, United States (enrolling)
• University of Texas Austin — Austin, Texas, United States (enrolling)
• University of Texas Health Science Center — Houston, Texas, United States (enrolling)
• University of Alabama — Tuscaloosa, Alabama, United States (enrolling)
• University of South Florida — Tampa, Florida, United States (enrolling)
• Tufts University — Boston, Massachusetts, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Washington University in St. Louis — St Louis, Missouri, United States (enrolling)
• University of New Mexico — Albuquerque, New Mexico, United States (enrolling)
• Columbia University Irving Medical Center — New York, New York, United States (enrolling)
• Wake Forest University — Winston-Salem, North Carolina, United States (enrolling)
• The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine — Columbus, Ohio, United States (enrolling)
• Premier Health - Miami Valley Hospital — Dayton, Ohio, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (enrolling)
• Christiana Care — Newark, Delaware, United States
• University of North Caroline — Chapel Hill, North Carolina, United States
• Austin Maternal Fetal Medicine — Austin, Texas, United States
• Kettering Health — Kettering, Ohio, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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