Clinical trialNCT06445946RecruitingPhase 4Interventional

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

SponsorOhio State UniversityEnrollment1,572Gestational Diabetes MellitusPregnancy, High Risk

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Kartik Venkatesh, MD, PhD
Ohio State University
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

24 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Alabama
Tuscaloosa, Alabama, United States
Ashley Battarbee, MD
Recruiting
Cedars Sinai Medical Center
Los Angeles, California, United States
Tania Esakoff, MD
Recruiting
University of California San Francisco
San Francisco, California, United States
Nasim Sobhani, MD
Recruiting
Christiana Care
Newark, Delaware, United States
Withdrawn
University of South Florida
Tampa, Florida, United States
Anjali Kaimal, MD
Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Terminated
Massachusetts General Hospital
Boston, Massachusetts, United States
Camille Powe, MDLauren Fiechtner, MDLydia Shook, MD
Recruiting
Tufts University
Boston, Massachusetts, United States
Erika Werner, MDPatrick Catalano, MD
Recruiting
Washington University in St. Louis
St Louis, Missouri, United States
Sydney Thayer, MD
Recruiting
University of New Mexico
Albuquerque, New Mexico, United States
Vivek Katukuri, MD
Recruiting
Columbia University Irving Medical Center
New York, New York, United States
Noelia Zork, MD
Recruiting
University of North Caroline
Chapel Hill, North Carolina, United States
Withdrawn
Wake Forest University
Winston-Salem, North Carolina, United States
David Stamilio, MD
Recruiting
the Ohio State University Wexner Medical Center Ob/gyn Maternal and Fetal Medicine
Columbus, Ohio, United States
Ann S McAlearney, ScDAnne Trinh, MPHChristine Field, MDKartik Venkatesh, MD, PhDMaged Costantine, MD, MBAMark Landon, MDSteven Gabbe, MD
Recruiting
Premier Health - Miami Valley Hospital
Dayton, Ohio, United States
Samantha Wiegand, MD
Recruiting
Kettering Health
Kettering, Ohio, United States
Not, yet, recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Maisa Feghali, MD
Recruiting
Brown University
Providence, Rhode Island, United States
Martha Kole-White, MD
Recruiting
University of South Carolina Greenville
Greenville, South Carolina, United States
Kacey Eichelberger, MD
Recruiting
Austin Maternal Fetal Medicine
Austin, Texas, United States
Not, yet, recruiting
University of Texas Austin
Austin, Texas, United States
Lorie Harper, MD
Recruiting
University of Texas Health Science Center
Houston, Texas, United States
Hector Mendez-Figueroa, MD
Recruiting
Eastern Virginia Medical School - Old Dominion University
Norfolk, Virginia, United States
George Saade, MDMalgorzata Mlynarczyk, MD
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

InsulinMetformin →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 1 Aug 2024
Primary completion: 31 Dec 2029
Completion: 31 Dec 2030
Last update posted: 25 Jun 2026
Registered enrollment: 1,572
Registry id: NCT06445946

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.