Back to resultsTreatment of Mild Gestational Diabetes With Glyburide Versus Placebo
Primary Purpose
Mild Gestational Diabetes
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Glyburide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Mild Gestational Diabetes
Eligibility Criteria
Inclusion Criteria:
- A glucose value of ≥140 mg/dl on a 50-gram oral glucose loading test by plasma at gestational age between 24 weeks 0 days and 27 weeks 6 days based on clinical information
- An Abnormal 3-hour oral glucose tolerance test with a fasting glucose of ≤105 mg/dl
- Gestational age of less than or equal to 28 weeks and 0 days at the time of consent/randomization
- Singleton gestation
Exclusion Criteria:
- Established pregestational diabetes
- Abnormal gestational diabetes testing (≥140) prior to 24 weeks 0 days of gestation. Women who have a negative glucose loading test (<140mg/dl) before 24 weeks may still be considered for this study if they present again for glucose tolerance testing between 24 and 27 weeks.
- Multiple gestations
- Known major fetal anomaly or fetal demise
- Any renal disease with serum creatinine of >1.0
- Known liver disease such as hepatitis
- Maternal or fetal conditions likely to require imminent or very preterm delivery such as preeclampsia, preterm premature rupture of the membranes, preterm labor, and intrauterine fetal growth restriction
- Known hypersensitivity or allergic reaction to Glyburide
Sites / Locations
- Parkland Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Glyburide
Placebo
Arm Description
Women with mild gestational diabetes will be started ADA diet and a low dose of Glyburide and their medication dosage will be titrated as necessary during the pregnancy to achieve glucose control.
Women with mild gestational diabetes will be started ADA diet and placebo.
Outcomes
Primary Outcome Measures
Mean Fetal Weight at Birth
Secondary Outcome Measures
Number of Participants With Large for Gestational Age Infants
Birth weight exceeding the 90th percentile for the gestational age at delivery.
Macrosomia
birth weight 4,000 g or greater
Neonatal Intensive Care Unit Admissions
Rate of Cesarean Delivery
Diagnosis of Pregnancy-induced Hypertension
Shoulder Dystocia
Need for Insulin Treatment
3rd or 4th Degree Perineal Laceration
Chorioamnionitis
Maternal fever >=38.0°C
Need for Insulin Therapy
Full Information
NCT ID
NCT00744965
First Posted
August 29, 2008
Last Updated
March 6, 2020
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00744965
Brief Title
Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo
Official Title
A Randomized Controlled Clinical Trial of Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 16, 2008 (Actual)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a randomized prospective trial which addresses the question of whether use of an oral hypoglycemic agent as an adjunct to diet therapy in women with mild gestational diabetes will result in achieving euglycemia in a shorter period of time and, in turn, result in less frequent maternal and neonatal morbidities. This study is designed to test the hypothesis that in women with mild GDM, use of Glyburide in addition to diet and nutritional counseling lowers mean infant birth weight by 200 grams as compared with diet and nutritional counseling alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Gestational Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
395 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glyburide
Arm Type
Active Comparator
Arm Description
Women with mild gestational diabetes will be started ADA diet and a low dose of Glyburide and their medication dosage will be titrated as necessary during the pregnancy to achieve glucose control.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Women with mild gestational diabetes will be started ADA diet and placebo.
Intervention Type
Drug
Intervention Name(s)
Glyburide
Intervention Description
Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sham dose adjustments of the placebo will be made.
Primary Outcome Measure Information:
Title
Mean Fetal Weight at Birth
Time Frame
Immediately after delivery of fetus
Secondary Outcome Measure Information:
Title
Number of Participants With Large for Gestational Age Infants
Description
Birth weight exceeding the 90th percentile for the gestational age at delivery.
Time Frame
After delivery
Title
Macrosomia
Description
birth weight 4,000 g or greater
Time Frame
After delivery
Title
Neonatal Intensive Care Unit Admissions
Time Frame
Until hospital discharge
Title
Rate of Cesarean Delivery
Time Frame
After delivery
Title
Diagnosis of Pregnancy-induced Hypertension
Time Frame
until hospital discharge
Title
Shoulder Dystocia
Time Frame
at delivery
Title
Need for Insulin Treatment
Time Frame
after delivery
Title
3rd or 4th Degree Perineal Laceration
Time Frame
at delivery
Title
Chorioamnionitis
Description
Maternal fever >=38.0°C
Time Frame
intrapartum
Title
Need for Insulin Therapy
Time Frame
throughout pregnancy and delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A glucose value of ≥140 mg/dl on a 50-gram oral glucose loading test by plasma at gestational age between 24 weeks 0 days and 27 weeks 6 days based on clinical information
An Abnormal 3-hour oral glucose tolerance test with a fasting glucose of ≤105 mg/dl
Gestational age of less than or equal to 28 weeks and 0 days at the time of consent/randomization
Singleton gestation
Exclusion Criteria:
Established pregestational diabetes
Abnormal gestational diabetes testing (≥140) prior to 24 weeks 0 days of gestation. Women who have a negative glucose loading test (<140mg/dl) before 24 weeks may still be considered for this study if they present again for glucose tolerance testing between 24 and 27 weeks.
Multiple gestations
Known major fetal anomaly or fetal demise
Any renal disease with serum creatinine of >1.0
Known liver disease such as hepatitis
Maternal or fetal conditions likely to require imminent or very preterm delivery such as preeclampsia, preterm premature rupture of the membranes, preterm labor, and intrauterine fetal growth restriction
Known hypersensitivity or allergic reaction to Glyburide
Facility Information:
Facility Name
Parkland Memorial Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26241419
Citation
Casey BM, Duryea EL, Abbassi-Ghanavati M, Tudela CM, Shivvers SA, McIntire DD, Leveno KJ. Glyburide in Women With Mild Gestational Diabetes: A Randomized Controlled Trial. Obstet Gynecol. 2015 Aug;126(2):303-309. doi: 10.1097/AOG.0000000000000967.
Results Reference
result
Learn more about this trial
Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo
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