NCT01329016

Brief Summary

This is a pharmacokinetic and pharmacodynamic study evaluating glyburide, metformin, and combination treatment for gestational diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
177

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2011

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

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 22, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 5, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2015

Completed
Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

3.7 years

First QC Date

March 22, 2011

Last Update Submit

May 7, 2026

Conditions

Gestational Diabetes Mellitus

Keywords

PregnancyGlyburideMetforminPharmacokineticsPharmacodynamics

Outcome Measures

Primary Outcomes (1)

  • Study drug dosage in pregnancy

    (1) Determination of metformin dosage in pregnancy needed to produce comparable concentrations to the approved dosage range in non-pregnant women. (2)To compare metformin apparent oral clearance in pregnant and non-pregnant women. (3)To evaluate the effect of GLY monotherapy, MET monotherapy, and GLY-MET combination on insulin sensitivity, beta-cell responsivity index and disposition index (response vectors) describing the mechanism and magnitude of effect.

    Completion of data collection (4-5mnths on average in GDM and healthy pregnant women and max of 6 months in newly diagnosed T2DMs)

Secondary Outcomes (1)

  • Determine GLY and MET PK parameters

    Conclusion of data collection (up to 6 months)

Study Arms (3)

GDM Subjects

ACTIVE COMPARATOR

Women with GDM requiring treatment

Drug: GlyburideDrug: MetforminDrug: Glyburide-Metformin combination

Non-pregnant Type 2 Diabetes Milletus Subjects

NO INTERVENTION

Non-pregnant women with Type 2 diabetes mellitus who plan to use metformin treatment

Healthy Pregnant Women

NO INTERVENTION

Healthy pregnant women with normal 1-hour glucose tolerance test

Interventions

GlyburideDRUG

Women with GDM who require treatment will be given glyburide 2.5 mg. Medication will be given at least twice daily and equal doses will be given for each dosing time for the 3 days prior to the pharmacokinetic study day.

GDM Subjects
MetforminDRUG

Women with GDM requiring treatment will be given metformin 500 mg. Medication will be administered at least twice daily and equal doses will be given for each dosing time for the 3 days prior to the pharmacokinetic study day.

GDM Subjects
Glyburide-Metformin combinationDRUG

Women with GDM requiring treatment will be given glyburide 2.5 mg with metformin 500 mg. Medications will be administered at least twice daily and equal doses will be given for each dosing time 3 days prior to the pharmacokinetic study day.

GDM Subjects

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Gestational Diabetes Subject Selection
  • Pregnant women (singleton pregnancy)
  • Gestational diabetes mellitus
  • Able to give written informed consent
  • Drug treatment is required for GDM
  • Gestational age 20-32 weeks
  • Gestational diabetes diagnosis must occur after 20 weeks and prior to 32 weeks gestation
  • Randomization and treatment initiation must occur no later than 32 weeks gestation
  • Willing to avoid ethanol
  • years of age
  • Type 2 Diabetes Mellitus Subject Selection
  • Able to give written informed consent
  • New diagnosis of type 2 diabetes mellitus
  • Plan to receive metformin for treatment of type 2 diabetes mellitus
  • years of age
  • +10 more criteria

You may not qualify if:

  • Women with GDM and T2DM
  • Women taking medications expected to interact with glyburide, metformin or alter blood glucose concentrations
  • Serum creatinine \> 1.2 mg/dL
  • Hematocrit \< 28%
  • Allergy to glyburide, metformin or sulfa
  • Significant hepatic disease
  • Congestive heart failure or history of MI
  • Moderate to severe pulmonary disease
  • Adrenal or pituitary insufficiency
  • Healthy Pregnant Women
  • Receiving any hypoglycemic agents
  • Receiving corticosteroids
  • Known kidney, liver, heart, pulmonary, adrenal or pituitary disease
  • Hematocrit \< 28%
  • Neonates
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (3)

  • Liao MZ, Flood Nichols SK, Ahmed M, Clark S, Hankins GD, Caritis S, Venkataramanan R, Haas D, Quinney SK, Haneline LS, Tita AT, Manuck T, Wang J, Thummel KE, Brown LM, Ren Z, Easterling TR, Hebert MF. Effects of Pregnancy on the Pharmacokinetics of Metformin. Drug Metab Dispos. 2020 Apr;48(4):264-271. doi: 10.1124/dmd.119.088435. Epub 2020 Jan 24.

    PMID: 31980499RESULT

  • Shuster DL, Shireman LM, Ma X, Shen DD, Flood Nichols SK, Ahmed MS, Clark S, Caritis S, Venkataramanan R, Haas DM, Quinney SK, Haneline LS, Tita AT, Manuck TA, Thummel KE, Brown LM, Ren Z, Brown Z, Easterling TR, Hebert MF. Pharmacodynamics of Glyburide, Metformin, and Glyburide/Metformin Combination Therapy in the Treatment of Gestational Diabetes Mellitus. Clin Pharmacol Ther. 2020 Jun;107(6):1362-1372. doi: 10.1002/cpt.1749. Epub 2020 Jan 25.

    PMID: 31869430RESULT

  • Shuster DL, Shireman LM, Ma X, Shen DD, Flood Nichols SK, Ahmed MS, Clark S, Caritis S, Venkataramanan R, Haas DM, Quinney SK, Haneline LS, Tita AT, Manuck TA, Thummel KE, Morris Brown L, Ren Z, Brown Z, Easterling TR, Hebert MF. Pharmacodynamics of Metformin in Pregnant Women With Gestational Diabetes Mellitus and Nonpregnant Women With Type 2 Diabetes Mellitus. J Clin Pharmacol. 2020 Apr;60(4):540-549. doi: 10.1002/jcph.1549. Epub 2019 Nov 19.

    PMID: 31742716RESULT

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

GlyburideMetformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfonylurea CompoundsUreaAmidesOrganic ChemicalsSulfonesSulfur CompoundsBiguanidesGuanidinesAmidines

Study Officials

  • Mary F. Hebert, PharmD, FCCP

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Steve Caritis, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

  • Gary DV Hankins, MD

    University of Texas

    PRINCIPAL INVESTIGATOR

  • David Flockhart, MD, PhD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 22, 2011

First Posted

April 5, 2011

Study Start

July 1, 2011

Primary Completion

February 28, 2015

Study Completion

February 28, 2015

Last Updated

May 11, 2026

Record last verified: 2026-05

Locations

US(4)