Glycemic Profile in Women With Gestational Diabetes Treated With Glyburide

NCT01947699 | Withdrawn Phase 4

• 1 other identifier: UPMC_GLY_GDM
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• Glucose levels throughout the day

  One week

Study Arms (3)

Glyburide once daily

EXPERIMENTAL

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

Drug: Glyburide; Device: Continuous glucose monitor

Glyburide twice daily

EXPERIMENTAL

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

Drug: Glyburide; Device: Continuous glucose monitor

Mixed meal tolerance test.

EXPERIMENTAL

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.

Drug: Glyburide

Interventions

Glyburide DRUG

Glyburide once daily; Glyburide twice daily; Mixed meal tolerance test.

Continuous glucose monitor DEVICE

Glyburide once daily; Glyburide twice daily

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• 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.

  PMID: 19295505 BACKGROUND

• Caritis SN, Hebert MF. A pharmacologic approach to the use of glyburide in pregnancy. Obstet Gynecol. 2013 Jun;121(6):1309-1312. doi: 10.1097/AOG.0b013e31829007f0.

  PMID: 23812467 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Glyburide

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sulfonylurea Compounds; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Study Officials

• Maisa Feghali, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow - Maternal Fetal Medicine & Obstetric Pharmacology

Study Record Dates

• First Submitted: September 17, 2013
• First Posted: September 20, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: May 11, 2016

Record last verified: 2016-05

Locations

US (1)