Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445946
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-21
Brief Title:
DECIDE A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
DECIDE A Comparative Effectiveness Trial of Oral Metformin Versus Injectable Insulin for the Treatment of Gestational Diabetes
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DECIDE
Brief Summary:
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 1572 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 1572 pregnant individuals with GDM who need pharmacotherapy will be recruited at 20 US sites using consistent treatment criteria to metformin versus insulin Participants and their children will be followed through delivery to two years postpartum
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 1572 pregnant individuals with GDM who need pharmacotherapy will be recruited at 20 US sites using consistent treatment criteria to metformin versus insulin Participants and their children will be followed through delivery to two years postpartum
Detailed Description:
Gestational diabetes mellitus GDM is one of the most common medical complications of pregnancy Glycemic control decreases the risk of adverse pregnancy outcomes for the pregnant individual with GDM and the infant exposed in utero 1 One in four individuals with GDM will require pharmacotherapy to achieve glycemic control Insulin has been the mainstay of pharmacotherapy Metformin is an alternative option increasingly used in clinical practice 2 Both insulin and metformin reduce the risk of adverse pregnancy outcomes but comparative effectiveness data from a well-characterized adequately powered and diverse US population remain lacking 3 Because metformin crosses the placenta long-term safety data in particular the risk of childhood obesity from exposed children are also needed In addition the patient-reported experiences of individuals with GDM requiring pharmacotherapy remains to be characterized including barriers for and facilitators of metformin versus insulin use
In a two-arm open-label pragmatic comparative effectiveness randomized controlled trial RCT the DECIDE Study will examine whether metformin is not inferior to insulin in reducing adverse pregnancy outcomes and is comparably safe for exposed mothers and children and whether patient-reported factors including facilitators of and barriers to use differ between metformin versus insulin use The DECIDE Study Consortium will recruit and retain 1572 pregnant individuals with GDM who need pharmacotherapy at 20 US sites to metformin versus insulin and follow them and their children through delivery and then to 2-years
Primary aim
To evaluate whether outcomes in pregnant individuals randomized to metformin are not inferior to those in pregnant individuals randomized to insulin for the composite adverse neonatal outcome defined as large-for-gestational-age birthweight LGA hypoglycemia hyperbilirubinemia or death
Secondary aims
1 To evaluate whether mean child body mass index BMI at 2 years of age is higher in the offspring of pregnant individuals randomized to metformin
2 To conduct a qualitative or mixed-methods analyses on a subgroup of participants to understand facilitators and barriers associated with metformin versus insulin use and heterogeneity of treatment effects HTE to facilitate evidence-based pharmacotherapy
3 To evaluate whether pregnant individuals randomized to metformin have equivalent maternal hypertensive disorder of pregnancy gestational weight gain mode of delivery and obstetric anal sphincter injuries and neonatal preterm birth mechanical ventilation NICU admission oxygen support and respiratory distress syndrome outcomes
4 To evaluate whether pregnant individuals randomized to metformin have equivalent maternal obesity anthropometry adiposity diabetes hypertension cholesterol and metabolic profile and child obesity anthropometry and adiposity outcomes at 2-years postpartum
5 To evaluate whether pregnant individuals randomized to metformin have equivalent patient-reported outcomes PROs as measured at 6 weeks postpartum and at 2 years postpartum
In a two-arm open-label pragmatic comparative effectiveness randomized controlled trial RCT the DECIDE Study will examine whether metformin is not inferior to insulin in reducing adverse pregnancy outcomes and is comparably safe for exposed mothers and children and whether patient-reported factors including facilitators of and barriers to use differ between metformin versus insulin use The DECIDE Study Consortium will recruit and retain 1572 pregnant individuals with GDM who need pharmacotherapy at 20 US sites to metformin versus insulin and follow them and their children through delivery and then to 2-years
Primary aim
To evaluate whether outcomes in pregnant individuals randomized to metformin are not inferior to those in pregnant individuals randomized to insulin for the composite adverse neonatal outcome defined as large-for-gestational-age birthweight LGA hypoglycemia hyperbilirubinemia or death
Secondary aims
1 To evaluate whether mean child body mass index BMI at 2 years of age is higher in the offspring of pregnant individuals randomized to metformin
2 To conduct a qualitative or mixed-methods analyses on a subgroup of participants to understand facilitators and barriers associated with metformin versus insulin use and heterogeneity of treatment effects HTE to facilitate evidence-based pharmacotherapy
3 To evaluate whether pregnant individuals randomized to metformin have equivalent maternal hypertensive disorder of pregnancy gestational weight gain mode of delivery and obstetric anal sphincter injuries and neonatal preterm birth mechanical ventilation NICU admission oxygen support and respiratory distress syndrome outcomes
4 To evaluate whether pregnant individuals randomized to metformin have equivalent maternal obesity anthropometry adiposity diabetes hypertension cholesterol and metabolic profile and child obesity anthropometry and adiposity outcomes at 2-years postpartum
5 To evaluate whether pregnant individuals randomized to metformin have equivalent patient-reported outcomes PROs as measured at 6 weeks postpartum and at 2 years postpartum
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None