Glycemic Profile in Women With Gestational Diabetes Treated With Glyburide

Phase 4

Withdrawn

• Conditions: Gestational Diabetes
• Interventions: Drug: Glyburide; Device: Continuous glucose monitor

• Registration Number: NCT01947699
• Lead Sponsor: University of Pittsburgh

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-17
• Study First Submitted QC: 2013-09-17
• Study First Posted: 2013-09-20
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glyburide once daily	Continuous glucose monitor	Timing of glyburide dosing will be changed, glucose will be monitored using continuous a glucose monitor.
Glyburide twice daily	Glyburide	Dose interval and timing of glyburide dose will be changed, glucose will be monitored using continuous a glucose monitor.
Glyburide twice daily	Continuous glucose monitor	Dose interval and timing of glyburide dose will be changed, glucose will be monitored using continuous a glucose monitor.
Glyburide once daily	Glyburide	Timing of glyburide dosing will be changed, glucose will be monitored using continuous a glucose monitor.
Mixed meal tolerance test.	Glyburide	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.

Primary Outcome Measures

Name	Time	Method
Glucose levels throughout the day	One week

Trial Locations

Locations (1)

Magee Womens Hospital of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States