Mild Gestational Diabetes
Conditions
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.
Interventions
DRUGGlyburide
Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.
DRUGPlacebo
Sham dose adjustments of the placebo will be made.
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Fetal Weight at Birth | Immediately after delivery of fetus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Macrosomia | After delivery | birth weight 4,000 g or greater |
| Neonatal Intensive Care Unit Admissions | Until hospital discharge | — |
| Rate of Cesarean Delivery | After delivery | — |
| Diagnosis of Pregnancy-induced Hypertension | until hospital discharge | — |
| Number of Participants With Large for Gestational Age Infants | After delivery | Birth weight exceeding the 90th percentile for the gestational age at delivery. |
| Need for Insulin Treatment | after delivery | — |
| 3rd or 4th Degree Perineal Laceration | at delivery | — |
| Chorioamnionitis | intrapartum | Maternal fever \>=38.0°C |
| Need for Insulin Therapy | throughout pregnancy and delivery | — |
| Shoulder Dystocia | at delivery | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Glyburide 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.
Glyburide: Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control. | 189 |
| Placebo Women with mild gestational diabetes will be started ADA diet and placebo.
Placebo: Sham dose adjustments of the placebo will be made. | 186 |
| Total | 375 |
Baseline characteristics
| Characteristic | Placebo | Total | Glyburide |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 186 Participants | 375 Participants | 189 Participants |
| Age, Continuous | 31.2 years STANDARD_DEVIATION 6 | 31.2 years STANDARD_DEVIATION 6 | 31.3 years STANDARD_DEVIATION 6 |
| Region of Enrollment United States | 186 Participants | 375 Participants | 189 Participants |
| Sex: Female, Male Female | 186 Participants | 375 Participants | 189 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 186 | 0 / 189 |
| other Total, other adverse events | 0 / 186 | 0 / 189 |
| serious Total, serious adverse events | 0 / 186 | 1 / 189 |
Outcome results
Primary
Mean Fetal Weight at Birth
Time frame: Immediately after delivery of fetus
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Fetal Weight at Birth | 3355 grams | Standard Deviation 521 |
| Glyburide | Mean Fetal Weight at Birth | 3322 grams | Standard Deviation 481 |
Secondary
3rd or 4th Degree Perineal Laceration
Time frame: at delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | 3rd or 4th Degree Perineal Laceration | 5 Participants |
| Glyburide | 3rd or 4th Degree Perineal Laceration | 1 Participants |
Secondary
Chorioamnionitis
Maternal fever \>=38.0°C
Time frame: intrapartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Chorioamnionitis | 12 Participants |
| Glyburide | Chorioamnionitis | 15 Participants |
Secondary
Diagnosis of Pregnancy-induced Hypertension
Time frame: until hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Diagnosis of Pregnancy-induced Hypertension | 12 Participants |
| Glyburide | Diagnosis of Pregnancy-induced Hypertension | 15 Participants |
Secondary
Macrosomia
birth weight 4,000 g or greater
Time frame: After delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Macrosomia | 18 Participants |
| Glyburide | Macrosomia | 13 Participants |
Secondary
Need for Insulin Therapy
Time frame: throughout pregnancy and delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Need for Insulin Therapy | 4 Participants |
| Glyburide | Need for Insulin Therapy | 4 Participants |
Secondary
Need for Insulin Treatment
Time frame: after delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Need for Insulin Treatment | 4 Participants |
| Glyburide | Need for Insulin Treatment | 4 Participants |
Secondary
Neonatal Intensive Care Unit Admissions
Time frame: Until hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Neonatal Intensive Care Unit Admissions | 11 Participants |
| Glyburide | Neonatal Intensive Care Unit Admissions | 13 Participants |
Secondary
Number of Participants With Large for Gestational Age Infants
Birth weight exceeding the 90th percentile for the gestational age at delivery.
Time frame: After delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Large for Gestational Age Infants | 22 Participants |
| Glyburide | Number of Participants With Large for Gestational Age Infants | 20 Participants |
Secondary
Rate of Cesarean Delivery
Time frame: After delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Rate of Cesarean Delivery | 67 Participants |
| Glyburide | Rate of Cesarean Delivery | 70 Participants |
Secondary
Shoulder Dystocia
Time frame: at delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Shoulder Dystocia | 1 Participants |
| Glyburide | Shoulder Dystocia | 0 Participants |