DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOhio State University
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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Metformin
DrugIndividuals randomized to this arm will receive oral metformin tablets for their Gestational diabetes mellitus treatment.
Insulin
DrugIndividuals randomized to this arm will receive injectable insulin for their Gestational diabetes mellitus treatment.
Treatment groups
1,572 Participants
are divided into 2 treatment groupsGroup A: MetforminExperimental treatment 1 intervention
Group B: InsulinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
A neonatal composite adverse outcome of large-for-gestational-age (LGA) birthweight, hypoglycemia, hyperbilirubinemia, and/or death.
LGA will be defined as a birthweight ≥90th%tile for gestational age based on a US birth certificate reference adjusted for parity and/or fetal sex. Neonatal hypoglycemia will be defined as a blood glucose \<35 mg/dL or treatment \<24 hours after birth with either IV, PO, or gel glucose therapy. Neonatal hyperbilirubinemia will be defined as treated with phototherapy or exchange transfusion in the first postnatal week and either treatment in the first postnatal week or kernicterus. Fetal or neonatal death can be due to any indication between randomization to hospital discharge or 30 days postnatal if still hospitalized (excluding voluntary pregnancy termination).
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.2
Child body mass index (BMI) at 2 years of age
Child BMI measured in kg/m2 as a continuous measure standardized using U.S. CDC reference adjusted for child sex
Time frame
2 years of age.Secondary outcomes
1
Hypertensive disorder of pregnancy, HDP (maternal)
HDP will include either gestational hypertension or preeclampsia. Gestational hypertension will be defined as: systolic blood pressure of 140 mm Hg or more or diastolic blood pressure of 90 mm Hg or more on two occasions at least 4 hours apart after 20 weeks of gestation in a woman with a previously normal blood pressure. Preeclampsia will be defined as: above blood pressure criteria AND proteinuria (300 mg or more per 24 hour urine collection, protein/creatinine ratio of 0.3 mg/dL or more, or dipstick reading of 2+) OR thrombocytopenia (platelet count less than 100 109/L), renal insufficiency (serum creatinine greater than 1.1 mg/dL or a doubling of the serum creatinine concentration in the absence of other renal disease), impaired liver function (elevated blood concentrations of liver transaminases to twice normal concentration), pulmonary edema, new-onset headache or visual symptoms not attributed to other diagnoses.
Time frame
Randomization to delivery2
Gestational weight gain (maternal)
Gestational weight gain between weight at first prenatal visit and weight at delivery based on z-score and defined as excess versus within Institute of Medicine (IOM) recommendations based on first pregnancy BMI.
Time frame
Initiation of prenatal care to delivery3
Mode of delivery (maternal)
Cesarean delivery or vaginal delivery
Time frame
At birth4
Obstetric perineal/anal sphincter injuries (maternal)
First degree: Injury to perineal skin only; Second degree: Injury to perineum involving perineal muscles but not involving anal sphincter; Third degree: Injury to perineum involving anal sphincter complex, including 3a: Less than 50% of external anal sphincter thickness torn; 3b: More than 50% external anal sphincter thickness torn; and 3c: Both external anal sphincter and internal anal sphincter torn; and Fourth degree: Injury to perineum involving anal sphincter complex (external anal sphincter and internal anal sphincter) and anal epithelium.
Time frame
At birthSponsors and contacts
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Ohio State University
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
The George Washington University Biostatistics Center
Collaborator
Source ClinicalTrials.gov