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Research was competing with other projects in the department, and no patients were recruited.
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A pragmatic, comparative effectiveness trial of glyburide versus metformin.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glyburide | Active Comparator | hypoglycemic agent approved for treatment of GDMA2 |
|
| Metformin | Active Comparator | hypoglycemic agent approved for treatment of GDMA2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glyburide | Drug | oral hypoglycemic agent |
| |
| Metformin |
| Measure | Description | Time Frame |
|---|---|---|
| Failure rate | need to start insulin therapy or another hypoglycemic agent during the pregnancy to maintain normal glucose levels or need for delivery due to hyperglycemia. | from onset of oral therapy until delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Mean overall plasma glucose | average of all postprandial glucose measurements | from enrollment to delivery |
| Mean weekly fasting glucose | average of all fasting glucose measurements |
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Inclusion Criteria:
We will include women between 20 and 34 weeks gestational age, with a diagnosis of GDM as per the following criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D005905 | Glyburide |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D013453 | Sulfonylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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patients will be randomized to two groups, one receiving glyburide and one receiving metformin.
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| Drug |
oral hypoglycemic agent |
|
| from enrollment to delivery |
| preeclampsia | preeclampsia | from enrollment to delivery |
| cesarean section | mode of delivery | from enrollment to delivery |
| neonatal hypoglycemia | neonatal hypoglycemia | from enrollment to delivery |
| LGA infant | LGA infant | from enrollment to delivery |
| birthweight > 4500 grams | birthweight > 4500 grams | from enrollment to deliveryfrom enrollment to delivery |
| gestational age at birth | gestational age at birth | from enrollment to delivery |
| incidence of medication side effects | nausea, emesis, diarrhea, abdomainal bloating | from enrollment to delivery |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D013450 |
| Sulfones |
| D013457 | Sulfur Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |