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

Recruiting Phase 4 Interventional Study
Gestational Diabetes Mellitus Pregnancy, High Risk
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
1,572 (estimated)
Sponsor
Ohio State University · Other
Who this trial is looking for

This trial is looking for pregnant women who are at least 18 years old and have been diagnosed with gestational diabetes, needing medication to manage their blood sugar. It’s important that they do not have any serious kidney problems or other specific health conditions that could complicate the study. Women are also excluded if they have certain fetal conditions or previous diabetes issues before pregnancy.

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About This Trial
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 pregnan…
Trial Locations
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Eligibility Criteria
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. * G…
Contacts

Kartik Venkatesh, MD, PhD

614-293-2222

kartik.venkatesh@osumc.edu

CONTACT

Anna Bartholomew, MPH, BS, RN

614-685-3229

Anna.Bartholomew@osumc.edu

CONTACT