Could a pill replace insulin shots for gestational diabetes?

NCT ID NCT06445946

Recruiting now Disease control Sponsor: Ohio State University Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two treatments for gestational diabetes: oral metformin pills and injectable insulin. Researchers want to see if metformin is as good as insulin at preventing problems for mothers and babies, like high birth weight or low blood sugar. About 1,500 pregnant women across 20 U.S. sites will take part, and their children will be followed for two years after birth.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Metformin (oral tablet) and insulin (injectable)
What this could lead to: If metformin works as well as insulin, it could offer a simpler, pill-based option for managing gestational diabetes, avoiding daily injections.
What could go wrong: This is a Phase 4 trial, but results may show metformin is not as effective or safe as insulin for some outcomes. Individual responses vary, and metformin may have side effects like stomach upset.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus gestational diabetes Insulin Resistance

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

GESTATIONAL DIABETES MELLITUS PREGNANCY, HIGH RISK

Contacts and locations

Locations

Austin Maternal Fetal Medicine
NOT_YET_RECRUITING

Austin, Texas, 78758, United States
Beth Israel Deaconess Medical Center
TERMINATED

Boston, Massachusetts, 02215, United States
Brown University
RECRUITING

Providence, Rhode Island, 02912, United States
Cedars Sinai Medical Center
RECRUITING

Los Angeles, California, 90048, United States
Christiana Care
WITHDRAWN

Newark, Delaware, 19718, United States
Columbia University Irving Medical Center
RECRUITING

New York, New York, 10032, United States
Eastern Virginia Medical School - Old Dominion University
RECRUITING

Norfolk, Virginia, 23501, United States
Kettering Health
NOT_YET_RECRUITING

Kettering, Ohio, 45429, United States
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
Premier Health - Miami Valley Hospital
RECRUITING

Dayton, Ohio, 45409, United States
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
RECRUITING

Columbus, Ohio, 43210, United States
Tufts University
RECRUITING

Boston, Massachusetts, 02111, United States
University of Alabama
RECRUITING

Tuscaloosa, Alabama, 35487, United States
University of California San Francisco
RECRUITING

San Francisco, California, 94143, United States
University of New Mexico
RECRUITING

Albuquerque, New Mexico, 87131, United States
University of North Caroline
WITHDRAWN

Chapel Hill, North Carolina, 27599, United States
University of Pennsylvania
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh
RECRUITING

Pittsburgh, Pennsylvania, 15213, United States
University of South Carolina Greenville
RECRUITING

Greenville, South Carolina, 29605, United States
University of South Florida
RECRUITING

Tampa, Florida, 33620, United States
University of Texas Austin
RECRUITING

Austin, Texas, 78705, United States
University of Texas Health Science Center
RECRUITING

Houston, Texas, 77030, United States
Wake Forest University
RECRUITING

Winston-Salem, North Carolina, 27106, United States
Washington University in St. Louis
RECRUITING

St Louis, Missouri, 63130, United States

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