ClinicalTrials.gov
ClinicalTrials.gov Menu

Glyburide vs Glucovance in the Treatment of GDM (GGIG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02726490
Recruitment Status : Recruiting
First Posted : April 1, 2016
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
Lisa E. Moore, Texas Tech University Health Sciences Center, El Paso

Brief Summary:
A randomized comparison of glyburide to glucovance (metformin -glyburide) in the management of diabetes in pregnancy.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Drug: Glyburide Drug: Glucovance Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Glyburide vs Glucovance in the Treatment of Gestational Diabetes
Study Start Date : July 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Glyburide

Arm Intervention/treatment
Active Comparator: Glyburide
  • 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
Drug: Glyburide
glyburide 2.5milligrams (mg) at bedtime (qhs) increased as needed to a maximum of 20mg/day usually taken twice a day (BID)
Other Names:
  • micronase
  • diabeta
  • glynase

Active Comparator: Glucovance
  • 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.
Drug: Glucovance
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)
Other Name: combination glyburide and metformin




Primary Outcome Measures :
  1. efficacy of glyburide compared to glucovance [ Time Frame: during the index pregnancy ]
    failure rate of glyburide compared to glucovance in ability to achieve euglycemia


Secondary Outcome Measures :
  1. maternal hypoglycemia [ Time Frame: during the index pregnancy ]
    the rate of maternal hypoglycemia associated with each drug

  2. neonatal birthweight [ Time Frame: at birth ]
    infant weight at birth

  3. neonatal apgar scores [ Time Frame: at birth ]
    infant 1 minute and 5 minute apgar scores

  4. neonatal admission to the newborn intensive care unit (NICU) [ Time Frame: at birth or within the first 24 hours after birth ]
    admission to the Newborn intensive care unit (NICU)

  5. neonatal hypoglycemia [ Time Frame: up to 24 hours after delivery ]
    failure of the neonate to maintain blood glucose > 60 milligrams/deciliter (mg/dl)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02726490


Contacts
Contact: Lisa E Moore, MD 915-215-5100 lisa.e.moore@ttuhsc.edu
Contact: Nancy Rondeau, MPH 915-215-5121 nancy.u.rondeau@ttuhsc.edu

Locations
United States, Texas
TTUHSC El Paso Recruiting
El Paso, Texas, United States, 79905
Contact: Lisa E Moore, M.D.    915-215-5100      
Sponsors and Collaborators
Texas Tech University Health Sciences Center, El Paso
Investigators
Principal Investigator: Lisa E Moore, MD Texas Tech Health Sciences Center El Paso

Publications of Results:
Other Publications:
Responsible Party: Lisa E. Moore, Professor, Texas Tech University Health Sciences Center, El Paso
ClinicalTrials.gov Identifier: NCT02726490     History of Changes
Other Study ID Numbers: E16008
First Posted: April 1, 2016    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lisa E. Moore, Texas Tech University Health Sciences Center, El Paso:
gestational diabetes, pregnancy, diabetes

Additional relevant MeSH terms:
Diabetes, Gestational
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glyburide
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs