Failure Rate of GLyburide And Metformin Among Gestational Diabetics
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Primary Endpoint
- Failure rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- Female
- Accepts 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.
Arms & Interventions
Metformin
hypoglycemic agent approved for treatment of GDMA2
Intervention: Metformin (Drug)
Glyburide
hypoglycemic agent approved for treatment of GDMA2
Intervention: Glyburide (Drug)
Outcomes
Primary Outcomes
Failure rate
Time Frame: 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 Outcomes
- Mean overall plasma glucose(from enrollment to delivery)
- LGA infant(from enrollment to delivery)
- Mean weekly fasting glucose(from enrollment to delivery)
- preeclampsia(from enrollment to delivery)
- cesarean section(from enrollment to delivery)
- neonatal hypoglycemia(from enrollment to delivery)
- birthweight > 4500 grams(from enrollment to deliveryfrom enrollment to delivery)
- gestational age at birth(from enrollment to delivery)
- incidence of medication side effects(from enrollment to delivery)
Investigators
Jenifer Dinis Ballestas
Medical Doctor
The University of Texas Health Science Center, Houston