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Could a pill replace insulin shots for gestational diabetes?

NCT ID NCT06445946

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 1,572 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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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