Phase 4
Completed N=395
Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo
Mild Gestational Diabetes
Source: ClinicalTrials.gov NCT00744965 ↗
Enrolled (actual)
395
Serious AEs
0.3%
Results posted
Mar 2020
Primary outcomePrimary: Mean Fetal Weight at Birth — 3355; 3322 grams
◆ Published Evidence
Established
35citations · ~3 / year
Glyburide in Women With Mild Gestational Diabetes: A Randomized Controlled Trial.
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.
Linked Publications
-
Glyburide in Women With Mild Gestational Diabetes: A Randomized Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Fetal Weight at Birth |
3355; 3322 | — |
| SECONDARY Number of Participants With Large for Gestational Age Infants |
22; 20 | — |
| SECONDARY Macrosomia |
18; 13 | — |
| SECONDARY Neonatal Intensive Care Unit Admissions |
11; 13 | — |
| SECONDARY Rate of Cesarean Delivery |
67; 70 | — |
| SECONDARY Diagnosis of Pregnancy-induced Hypertension |
12; 15 | — |
| SECONDARY Shoulder Dystocia |
1; 0 | — |
| SECONDARY Need for Insulin Treatment |
4; 4 | — |
| SECONDARY 3rd or 4th Degree Perineal Laceration |
5; 1 | — |
| SECONDARY Chorioamnionitis |
12; 15 | — |
| SECONDARY Need for Insulin Therapy |
4; 4 | — |
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 ( 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
Data sourced from ClinicalTrials.gov (NCT00744965) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.