Failure Rate of GLyburide And Metformin Among Gestational Diabetics

Study Overview
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Brief Summary
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A pragmatic, comparative effectiveness trial of glyburide versus metformin.

Detailed Description
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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.

Official Title
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Failure Rate of GLyburide And Metformin Among Gestational Diabetics

Conditions
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Gestational Diabetes Mellitus, Class A2

Intervention / Treatment
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* Drug: Glyburide
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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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: 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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: patients will be randomized to two groups, one receiving glyburide and one receiving metformin.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glyburide<br>hypoglycemic agent approved for treatment of GDMA2 | Drug: Glyburide<br>* oral hypoglycemic agent<br>|
| Active Comparator: Metformin<br>hypoglycemic agent approved for treatment of GDMA2 | Drug: Metformin<br>* oral hypoglycemic agent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gestational diabetes, glyburide, metformin, failure rate