Glycemic Profile in Women With Gestational Diabetes Treated With Glyburide

Gestational Diabetes Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01947699
• Other study ID #: UPMC_GLY_GDM
• Status: Withdrawn
• Phase: Phase 4
• First received: September 17, 2013
• Last updated: May 10, 2016
• Start date: September 2013
• Est. completion date: September 2014

Study information

• Verified date: May 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: University of Pittsburgh Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

Drug:
• Glyburide

Device:
• Continuous glucose monitor

Locations

Country	Name	City	State
United States	Magee Womens Hospital of UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (2)

Caritis SN, Hebert MF. A pharmacologic approach to the use of glyburide in pregnancy. Obstet Gynecol. 2013 Jun;121(6):1309-12. doi: 10.1097/AOG.0b013e31829007f0. — View Citation

Hebert MF, Ma X, Naraharisetti SB, Krudys KM, Umans JG, Hankins GD, Caritis SN, Miodovnik M, Mattison DR, Unadkat JD, Kelly EJ, Blough D, Cobelli C, Ahmed MS, Snodgrass WR, Carr DB, Easterling TR, Vicini P; Obstetric-Fetal Pharmacology Research Unit Network. Are we optimizing gestational diabetes treatment with glyburide? The pharmacologic basis for better clinical practice. Clin Pharmacol Ther. 2009 Jun;85(6):607-14. doi: 10.1038/clpt.2009.5. Epub 2009 Mar 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose levels throughout the day		One week	No