Glycemic Profile in Women With Gestational Diabetes Treated With Glyburide

May 10, 2016 updated by: Maisa Feghali, University of Pittsburgh

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.

Study Overview

Status

Withdrawn

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee Womens Hospital of UPMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Glyburide once daily
Timing of glyburide dosing will be changed, glucose will be monitored using continuous a glucose monitor.
EXPERIMENTAL: Glyburide twice daily
Dose interval and timing of glyburide dose will be changed, glucose will be monitored using continuous a glucose monitor.
EXPERIMENTAL: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glucose levels throughout the day
Time Frame: One week
One week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

September 17, 2013

First Submitted That Met QC Criteria

September 17, 2013

First Posted (ESTIMATE)

September 20, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 11, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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