Glycemic Profile in Women With Gestational Diabetes Treated With Glyburide

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-09-30

Brief Summary

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Diabetes is more likely to occur during pregnancy. When present only in pregnancy it is called gestational diabetes, and it places both mom and baby at risk for complications. Glyburide is one of the currently used treatments for diabetes during pregnancy. This drug is a medication taken by mouth that decreases sugar levels in the blood. It is known to decrease the risk of complications linked to diabetes in pregnancy. Recent studies in pregnancy have described a difference in the way and how well the drug works compared to when used outside of pregnancy.

Oral blood sugar lowering agents are approved by the Food and Drug Administration (FDA) to lower blood sugar in non-pregnant subjects with diabetes. No oral (taken by mouth) blood-sugar lowering agents are FDA approved for use in pregnancy. Although Glyburide is not FDA approved for this use, it is the most commonly used oral blood sugar lowering agent in pregnancy.

This research study will help us learn more about the variations in blood sugar levels in women with diabetes in pregnancy who are taking glyburide and how changes in the timing of when the glyburide is taken would affect blood glucose levels. The goals of this study are:

* To find the how glucose changes throughout the day in women with diabetes in pregnancy receiving glyburide
* To learn the effect of changing the time of taking glyburide on glucose levels
* To learn the effect of changing the time between glyburide doses on glucose levels
* To see if insulin is secreted the same throughout the day in response to a morning dose of glyburide.

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Detailed Description

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Conditions

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Gestational Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Glyburide once daily

Timing of glyburide dosing will be changed, glucose will be monitored using continuous a glucose monitor.

Group Type EXPERIMENTAL

Glyburide

Intervention Type DRUG

Continuous glucose monitor

Intervention Type DEVICE

Glyburide twice daily

Dose interval and timing of glyburide dose will be changed, glucose will be monitored using continuous a glucose monitor.

Group Type EXPERIMENTAL

Glyburide

Intervention Type DRUG

Continuous glucose monitor

Intervention Type DEVICE

Mixed meal tolerance test.

Subjects will be admitted to the Clinical Translational Research Center, receive a Mixed meal tolerance test and have timed blood draws to assess the effect of glyburide on glucose and insulin metabolism.

Group Type EXPERIMENTAL

Glyburide

Intervention Type DRUG

Interventions

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Glyburide

Intervention Type DRUG

Continuous glucose monitor

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Pregnant women with gestational diabetes
* Singleton gestation
* Receiving glyburide for the treatment gestational diabetes
* Able to give consent

Exclusion Criteria

* Women who require insulin for the treatment of gestational diabetes
* Diagnosis of pregestational diabetes
* Poor glycemic control, \> 50% of blood glucose values over 200mg/dl prior to start of the study
* Women receiving medications that affect glycemic control e.g. steroids, within a week of enrollment.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No