Failure Rate of GLyburide And Metformin Among Gestational Diabetics

Gestational Diabetes Mellitus, Class A2 Clinical Trial

— GLAM  

Official title:

Failure Rate of GLyburide And Metformin Among Gestational Diabetics

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03078725
• Other study ID #: HSC-MS-16-1052
• Status: Withdrawn
• Phase: Phase 4
• Start date: June 20, 2017
• Est. completion date: May 10, 2018

Study information

• Verified date: May 2018
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A pragmatic, comparative effectiveness trial of glyburide versus metformin.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 10, 2018
• Est. primary completion date: March 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus, Class A2

Intervention

Drug:
• Glyburide
oral hypoglycemic agent
• Metformin
oral hypoglycemic agent

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean overall plasma glucose	average of all postprandial glucose measurements	from enrollment to delivery
Secondary	Mean weekly fasting glucose	average of all fasting glucose measurements	from enrollment to delivery
Secondary	preeclampsia	preeclampsia	from enrollment to delivery
Secondary	cesarean section	mode of delivery	from enrollment to delivery
Secondary	neonatal hypoglycemia	neonatal hypoglycemia	from enrollment to delivery
Secondary	LGA infant	LGA infant	from enrollment to delivery
Secondary	birthweight > 4500 grams	birthweight > 4500 grams	from enrollment to deliveryfrom enrollment to delivery
Secondary	gestational age at birth	gestational age at birth	from enrollment to delivery
Secondary	incidence of medication side effects	nausea, emesis, diarrhea, abdomainal bloating	from enrollment to delivery