NCT02726490

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jul 2016

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2018

Completed
Last Updated

October 12, 2020

Status Verified

October 1, 2020

Enrollment Period

2.1 years

First QC Date

March 29, 2016

Last Update Submit

October 7, 2020

Conditions

Gestational Diabetes

Keywords

gestational diabetes, pregnancy, diabetes

Outcome Measures

Primary Outcomes (1)

  • efficacy of glyburide compared to glucovance

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

    during the index pregnancy

Secondary Outcomes (5)

  • maternal hypoglycemia

    during the index pregnancy

  • neonatal birthweight

    at birth

  • neonatal apgar scores

    at birth

  • neonatal admission to the newborn intensive care unit (NICU)

    at birth or within the first 24 hours after birth

  • neonatal hypoglycemia

    up to 24 hours after delivery

Study Arms (2)

Glyburide

ACTIVE COMPARATOR

* 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

Glucovance

ACTIVE COMPARATOR

* 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

Interventions

GlyburideDRUG

glyburide 2.5milligrams (mg) at bedtime (qhs) increased as needed to a maximum of 20mg/day usually taken twice a day (BID)

Also known as: micronase, diabeta, glynase
Glyburide
GlucovanceDRUG

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)

Also known as: combination glyburide and metformin
Glucovance

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TTUHSC El Paso

El Paso, Texas, 79905, United States

Location

Related Publications (2)

  • 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.

    PMID: 18161398BACKGROUND

  • 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.

    PMID: 20027034RESULT

MeSH Terms

Conditions

Diabetes, GestationalDiabetes Mellitus

Interventions

GlyburideGlucovanceMetformin

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Sulfonylurea CompoundsUreaAmidesOrganic ChemicalsSulfonesSulfur CompoundsBiguanidesGuanidinesAmidines

Study Officials

  • Lisa E Moore, MD

    Texas Tech Health Sciences Center El Paso

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2016

First Posted

April 1, 2016

Study Start

July 1, 2016

Primary Completion

August 14, 2018

Study Completion

August 14, 2018

Last Updated

October 12, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)