Gestational Diabetes Mellitus, Class A2
Conditions
Keywords
gestational diabetes, glyburide, metformin, failure rate
Brief summary
A pragmatic, comparative effectiveness trial of glyburide versus metformin.
Detailed description
Patients with gestational diabetes requiring pharmaceutical treatment will be randomized to receive glyburide or metformin. Dose increases will be determined by the patient's physician. Patients will be determined to have failed either medication if glucose control can not be achieved with the maximum dose of the medication, if insulin is stared to achieve glucose control or if another oral agent is started along for glucose control.
Interventions
DRUGGlyburide
oral hypoglycemic agent
DRUGMetformin
oral hypoglycemic agent
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
patients will be randomized to two groups, one receiving glyburide and one receiving metformin.
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
We will include women between 20 and 34 weeks gestational age, with a diagnosis of GDM as per the following criteria: * 1 hour Glucose tolerance test of \>130 mg/dl, followed by two abnormal values on 3 hour Glucose tolerance test, or: * A single 1 hour Glucose tolerance test value of \> 200 mg/dl, and: * Failure to achieve glycemic control with diet and exercise or deemed to require pharmacological therapy as per physician's criteria
Exclusion criteria
* \- Known renal impairment. * Known hepatic disease. * Pre-gestational diabetes. * Known allergy to glyburide, metformin or sulfa drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failure rate | from onset of oral therapy until delivery | need to start insulin therapy or another hypoglycemic agent during the pregnancy to maintain normal glucose levels or need for delivery due to hyperglycemia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean weekly fasting glucose | from enrollment to delivery | average of all fasting glucose measurements |
| preeclampsia | from enrollment to delivery | preeclampsia |
| cesarean section | from enrollment to delivery | mode of delivery |
| neonatal hypoglycemia | from enrollment to delivery | neonatal hypoglycemia |
| Mean overall plasma glucose | from enrollment to delivery | average of all postprandial glucose measurements |
| birthweight > 4500 grams | from enrollment to deliveryfrom enrollment to delivery | birthweight \> 4500 grams |
| gestational age at birth | from enrollment to delivery | gestational age at birth |
| incidence of medication side effects | from enrollment to delivery | nausea, emesis, diarrhea, abdomainal bloating |
| LGA infant | from enrollment to delivery | LGA infant |
Outcome results
None listed