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Glyburide vs Glucovance in the Treatment of GDM (GGIG)

Primary Purpose

Gestational Diabetes

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Glyburide
Glucovance
Sponsored by
Texas Tech University Health Sciences Center, El Paso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes focused on measuring gestational diabetes, pregnancy, diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Gestational diabetes
  • Pregnancy > 12 weeks gestation
  • Ability to give consent

Exclusion Criteria:

  • Inability to consent to the study
  • Pre-existing diabetes
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Serum creatinine >1
  • Liver disease
  • Allergy to sulfa;
  • Allergy to glyburide;
  • Allergy to metformin;
  • Fetal anomalies

Sites / Locations

  • TTUHSC El Paso

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Glyburide

Glucovance

Arm Description

Patients will check and record blood glucose fasting and 1 hour after each meal each day. Patients will also keep a diary of all meals. The starting dose of glyburide may be 2.5milligrams (mg) to 5mg every day(QD) or twice daily (BID) depending on the degree of hyperglycemia. The dose of glyburide will be increased as needed to a maximum of 20mg /day. Antenatal testing will be initiated at 28 weeks Patients will receive monthly growth scans

Patients will check and record blood glucose fasting and 1 hour after each meal each day. Patients will also keep a diary of all meals. The starting dose of glucovance may be 1.25/250milligrams (mg) either once daily (QD) or twice a day (BID) increased to a maximum of 20mg/2000mg as needed. Patients will receive monthly growth scans Antenatal testing will be initiated at 28 weeks.

Outcomes

Primary Outcome Measures

efficacy of glyburide compared to glucovance
failure rate of glyburide compared to glucovance in ability to achieve euglycemia

Secondary Outcome Measures

maternal hypoglycemia
the rate of maternal hypoglycemia associated with each drug
neonatal birthweight
infant weight at birth
neonatal apgar scores
infant 1 minute and 5 minute apgar scores
neonatal admission to the newborn intensive care unit (NICU)
admission to the Newborn intensive care unit (NICU)
neonatal hypoglycemia
failure of the neonate to maintain blood glucose > 60 milligrams/deciliter (mg/dl)

Full Information

First Posted
March 29, 2016
Last Updated
October 7, 2020
Sponsor
Texas Tech University Health Sciences Center, El Paso
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1. Study Identification

Unique Protocol Identification Number
NCT02726490
Brief Title
Glyburide vs Glucovance in the Treatment of GDM
Acronym
GGIG
Official Title
Glyburide vs Glucovance in the Treatment of Gestational Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Lack of Recruitment
Study Start Date
July 2016 (undefined)
Primary Completion Date
August 14, 2018 (Actual)
Study Completion Date
August 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Tech University Health Sciences Center, El Paso

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A randomized comparison of glyburide to glucovance (metformin -glyburide) in the management of diabetes in pregnancy.
Detailed Description
This study will be a randomized open label trial of glyburide compared to glucovance in the management of gestational diabetes. We hypothesize that glucovance will provide improved glycemic control and a lower failure rate with no increase in neonatal adverse outcomes. Sixty-seven patients will be randomized by computer to each arm of the study. Outcomes will be glycemic control, failure rate of the drug to achieve glycemic goals, and neonatal outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
gestational diabetes, pregnancy, diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glyburide
Arm Type
Active Comparator
Arm Description
Patients will check and record blood glucose fasting and 1 hour after each meal each day. Patients will also keep a diary of all meals. The starting dose of glyburide may be 2.5milligrams (mg) to 5mg every day(QD) or twice daily (BID) depending on the degree of hyperglycemia. The dose of glyburide will be increased as needed to a maximum of 20mg /day. Antenatal testing will be initiated at 28 weeks Patients will receive monthly growth scans
Arm Title
Glucovance
Arm Type
Active Comparator
Arm Description
Patients will check and record blood glucose fasting and 1 hour after each meal each day. Patients will also keep a diary of all meals. The starting dose of glucovance may be 1.25/250milligrams (mg) either once daily (QD) or twice a day (BID) increased to a maximum of 20mg/2000mg as needed. Patients will receive monthly growth scans Antenatal testing will be initiated at 28 weeks.
Intervention Type
Drug
Intervention Name(s)
Glyburide
Other Intervention Name(s)
micronase, diabeta, glynase
Intervention Description
glyburide 2.5milligrams (mg) at bedtime (qhs) increased as needed to a maximum of 20mg/day usually taken twice a day (BID)
Intervention Type
Drug
Intervention Name(s)
Glucovance
Other Intervention Name(s)
combination glyburide and metformin
Intervention Description
glucovance (2.5/500) 1 taken orally (PO) at bed time (QHS) increased as needed to a maximum dose of (20/2000)/day usually taken twice a day (BID)
Primary Outcome Measure Information:
Title
efficacy of glyburide compared to glucovance
Description
failure rate of glyburide compared to glucovance in ability to achieve euglycemia
Time Frame
during the index pregnancy
Secondary Outcome Measure Information:
Title
maternal hypoglycemia
Description
the rate of maternal hypoglycemia associated with each drug
Time Frame
during the index pregnancy
Title
neonatal birthweight
Description
infant weight at birth
Time Frame
at birth
Title
neonatal apgar scores
Description
infant 1 minute and 5 minute apgar scores
Time Frame
at birth
Title
neonatal admission to the newborn intensive care unit (NICU)
Description
admission to the Newborn intensive care unit (NICU)
Time Frame
at birth or within the first 24 hours after birth
Title
neonatal hypoglycemia
Description
failure of the neonate to maintain blood glucose > 60 milligrams/deciliter (mg/dl)
Time Frame
up to 24 hours after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gestational diabetes Pregnancy > 12 weeks gestation Ability to give consent Exclusion Criteria: Inability to consent to the study Pre-existing diabetes Glucose-6-phosphate dehydrogenase (G6PD) deficiency Serum creatinine >1 Liver disease Allergy to sulfa; Allergy to glyburide; Allergy to metformin; Fetal anomalies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa E Moore, MD
Organizational Affiliation
Texas Tech Health Sciences Center El Paso
Official's Role
Principal Investigator
Facility Information:
Facility Name
TTUHSC El Paso
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18161398
Citation
Moore LE, Briery CM, Clokey D, Martin RW, Williford NJ, Bofill JA, Morrison JC. Metformin and insulin in the management of gestational diabetes mellitus: preliminary results of a comparison. J Reprod Med. 2007 Nov;52(11):1011-5.
Results Reference
background
PubMed Identifier
20027034
Citation
Moore LE, Clokey D, Rappaport VJ, Curet LB. Metformin compared with glyburide in gestational diabetes: a randomized controlled trial. Obstet Gynecol. 2010 Jan;115(1):55-59. doi: 10.1097/AOG.0b013e3181c52132.
Results Reference
result

Learn more about this trial

Glyburide vs Glucovance in the Treatment of GDM

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