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RECRUITING Phase 4 ClinicalTrials.gov

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

Sponsor: Ohio State University • ClinicalTrials.gov ID: NCT06445946

Registry updated: 2026-10-07
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Description

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.

Interventions

  • Metformin (Drug)
    Individuals randomized to this arm will receive oral metformin tablets for their Gestational diabetes mellitus treatment.
  • Insulin (Drug)
    Individuals randomized to this arm will receive injectable insulin for their Gestational diabetes mellitus treatment.

Eligibility criteria

Inclusion Criteria: * 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. Exclusion criteria: * 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.

Conditions

Gestational Diabetes Mellitus Pregnancy, High Risk

Locations

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

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record