Comparing Metformin and Insulin for Gestational Diabetes Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial compares the effectiveness of metformin versus insulin in treating gestational diabetes mellitus (GDM) in pregnant individuals. It is a randomized controlled trial involving 1,572 participants across 20 U.S. sites, focusing on whether metformin is as effective as insulin in reducing adverse pregnancy outcomes. The study also aims to assess the safety of both treatments for mothers and their children, as well as to explore patient-reported experiences regarding the use of these medications. Participants will be followed from pregnancy through two years postpartum to gather comprehensive data.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama
  Tuscaloosa, Alabama, United States Recruiting
• Cedars Sinai Medical Center
  Los Angeles, California, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• Yale School of Medicine
  New Haven, Connecticut, United States Recruiting
• University of South Florida
  Tampa, Florida, United States Recruiting
• Tufts University
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Kartik Venkatesh, MD, PhD — Ohio State University
• Study coordinator: Kartik Venkatesh, MD, PhD
• Email: kartik.venkatesh@osumc.edu
• Phone: 614-293-2222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.