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

Part of paid clinical trials in Tuscaloosa, Alabama.

Sponsor
Ohio State University
Study ID
NCT06445946
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Gestational Diabetes Mellitus
  • Pregnancy, High Risk

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Aug 1, 2024
Status verified
Jan 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
1,572 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Metformin
    Metformin as either immediate- or extended-release formulations can be utilized, and titrated to a maximum daily dose of 2,500 mg. Participants receiving metformin will have insulin added only if they have not achieved euglycemia for at least 30% of glucose values after generally receiving the maximum daily dose of metformin of 2,500 mg, or in select situations in the setting of participant intolerance due to mild gastrointestinal symptoms. Participants will be asked to continue taking metformin after treatment supplementation with insulin.
  • Experimental: Insulin
    Insulin will be initiated utilizing clinical standards using trimester-specific weight-based dosing criteria, including both basal and prandial insulins for up to a total of 4 daily injections. Consistent with clinical practice, some people may be managed with a single dose of intermediate- or long-acting insulin at night to treat isolated fasting hyperglycemia, while others may require additional treatment of postprandial hyperglycemia with shorter-acting insulin. The sites' insulin formularies include rapid- (Novolog and Humalog), intermediate- (Humulin N, Novolin N, and NPH), and long-acting insulins (Detemir and Lantus).

Primary Outcome Measure

A neonatal composite adverse outcome of large-for-gestational-age (LGA) birthweight, hypoglycemia, hyperbilirubinemia, and/or death. [ Time Frame: LGA at birth. Hypoglycemia <24 hours after birth. Hyperbilirubinemia within the first week after birth. Death between randomization to hospital discharge or 30 days postnatal. ]

Central Contacts

Locations (21)

FacilityCityStateZIPSite coordinators
University of AlabamaTuscaloosaAlabama35487
Ashley Battarbee, MD
[email protected]
Michael Jordan
[email protected]
Ashley Battarbee, MD (PRINCIPAL_INVESTIGATOR)
Cedars Sinai Medical CenterLos AngelesCalifornia90048
Tania Esakoff, MD
[email protected]
Marla Sharp
[email protected]
Tania Esakoff, MD (PRINCIPAL_INVESTIGATOR)
University of California San FranciscoSan FranciscoCalifornia94143
Nasim Sobhani, MD
[email protected]
Magie Fong
[email protected]
Nasim Sobhani, MD (PRINCIPAL_INVESTIGATOR)
University of South FloridaTampaFlorida33620
Anjali Kaimal Kaimal, MD
[email protected]
Maha Jumaily
[email protected]
Anjali Kaimal, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Chloe Zera, MD
[email protected]
Andy Ngyuen
[email protected]
Chloe Zera, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Lydia Shook, MD
[email protected]
Nancy Kingori
[email protected]
Lydia Shook, MD (PRINCIPAL_INVESTIGATOR)
Camille Powe, MD (SUB_INVESTIGATOR)
Lauren Fiechtner, MD (SUB_INVESTIGATOR)
Tufts UniversityBostonMassachusetts02111
Erika Werner, MD
[email protected]
Beth Marsh
[email protected]
Erika Werner, MD (PRINCIPAL_INVESTIGATOR)
Patrick Catalano, MD (SUB_INVESTIGATOR)
Washington University in St. LouisSt LouisMissouri63130
Megan Lawlor, MD
[email protected]
Emily Diveley, BSN, RN
[email protected]
314-362-4685
Sydney Thayer, MD (SUB_INVESTIGATOR)
University of New MexicoAlbuquerqueNew Mexico87131
Vivek Katukuri, MD
[email protected]
Karen Taylor
[email protected]
Vivek Katukuri, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Irving Medical CenterNew YorkNew York10032
Noelia Zork, MD
[email protected]
Joseph Celentano
[email protected]
Noelia Zork, MD (PRINCIPAL_INVESTIGATOR)
Wake Forest UniversityWinston-SalemNorth Carolina27106
David Stamilio, MD
[email protected]
Christina Tulbert
[email protected]
David Stamilio, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal MedicineColumbusOhio43210
Kartik Venkatesh, MD, PhD
[email protected]
614-293-2222
Kartik Venkatesh, MD, PhD (PRINCIPAL_INVESTIGATOR)
Mark Landon, MD (PRINCIPAL_INVESTIGATOR)
Maged Costantine, MD, MBA (SUB_INVESTIGATOR)
Ann S McAlearney, ScD (SUB_INVESTIGATOR)
Anne Trinh, MPH (SUB_INVESTIGATOR)
Steven Gabbe, MD (SUB_INVESTIGATOR)
Christine Field, MD (SUB_INVESTIGATOR)
Premier Health - Miami Valley HospitalDaytonOhio45409
Samantha Wiegand, MD
[email protected]
Emily Reynolds
[email protected]
Samantha Wiegand, MD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Celeste Durnwald, MD
[email protected]
215-615-3817
Elizabeth Norton, MPH, MBE
[email protected]
215-615-3817
University of PittsburghPittsburghPennsylvania15213
Maisa Feghali, MD
[email protected]
John Collins
[email protected]
Maisa Feghali, MD (PRINCIPAL_INVESTIGATOR)
Brown UniversityProvidenceRhode Island02912
Martha Kole-White, MD
[email protected]
Kelsey Inglesby
[email protected]
Martha Kole-White, MD (PRINCIPAL_INVESTIGATOR)
University of South Carolina GreenvilleGreenvilleSouth Carolina29605
Kacey Eichelberger, MD
[email protected]
Patti Parker
[email protected]
Kacey Eichelberger, MD (PRINCIPAL_INVESTIGATOR)
Austin Maternal Fetal MedicineAustinTexas78758
Mollie McDonnold, MD
512-821-2540
Heather Azarmehr, MSN, RN
[email protected]
737-415-6210
University of Texas AustinAustinTexas78705
Lorie Harper, MD
[email protected]
Mickey Roberts
[email protected]
Lorie Harper, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Health Science CenterHoustonTexas77030
Hector Mendez-Figueroa, MD
[email protected]
Laura Nixon
[email protected]
Hector Mendez-Figueroa, MD (PRINCIPAL_INVESTIGATOR)
Eastern Virginia Medical School - Old Dominion UniversityNorfolkVirginia23501
Malgorzata Mlynarczyk, MD
[email protected]
Cheryl Sparrer
[email protected]
Malgorzata Mlynarczyk, MD (PRINCIPAL_INVESTIGATOR)
George Saade, MD (SUB_INVESTIGATOR)

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University of Alabama· Tuscaloosa, ALCedars Sinai Medical Center· Los Angeles, CAUniversity of California San Francisco· San Francisco, CAUniversity of South Florida· Tampa, FLBeth Israel Deaconess Medical Center· Boston, MAMassachusetts General Hospital· Boston, MA

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