Glyburide and Metformin for Gestational Diabetes Mellitus (GDM)

NCT ID: NCT01329016

Last Updated: 2015-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2015-06-30

Brief Summary

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

Detailed Description

Gestational diabetes mellitus (GDM) is a common complication of pregnancy. Multiple treatment regimens are currently used for the management of GDM. Following failure of diet therapy, insulin, glyburide and metformin are all used in the treatment of GDM with the oral medications providing comparable outcomes with insulin but easier route of administration and schedule. The proposed work will evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of glyburide and metformin alone and in combination in order to lay the foundation in establishing dosage and response information that could be utilized in designing a phase III randomized trial that will ultimately evaluate GDM treatment optimization.

Conditions

Gestational Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GDM Subjects

Women with GDM requiring treatment

Group Type: ACTIVE_COMPARATOR

Glyburide

Intervention Type: DRUG

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.

Metformin

Intervention Type: DRUG

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.

Glyburide-Metformin combination

Intervention Type: DRUG

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.

Non-pregnant Type 2 Diabetes Milletus Subjects

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Healthy Pregnant Women

Healthy pregnant women with normal 1-hour glucose tolerance test

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Glyburide

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.

Intervention Type: DRUG

Metformin

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.

Intervention Type: DRUG

Glyburide-Metformin combination

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Gestational Diabetes Subject Selection

1. Pregnant women (singleton pregnancy)

2. Gestational diabetes mellitus

3. Able to give written informed consent

4. Drug treatment is required for GDM

5. 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

6. Willing to avoid ethanol

7. 18-45 years of age

Type 2 Diabetes Mellitus Subject Selection

1. Able to give written informed consent

2. New diagnosis of type 2 diabetes mellitus

3. Plan to receive metformin for treatment of type 2 diabetes mellitus

4. 18-45 years of age

5. Female

6. Negative pregnancy test

7. Hemoglobin A1C > 7%

Healthy Pregnant Women

1. Able to give written informed consent

2. Pregnant women (singleton)

3. Normal 1-hour glucose tolerance test

4. 20-32 weeks gestation

5. 18-45 years of age

Neonates: All the infants of the pregnant women participating in this study will be included

Exclusion Criteria

Women with GDM and T2DM

1. Women taking medications expected to interact with glyburide, metformin or alter blood glucose concentrations

2. Serum creatinine > 1.2 mg/dL

3. Hematocrit < 28%

4. Allergy to glyburide, metformin or sulfa

5. Significant hepatic disease

6. Congestive heart failure or history of MI

7. Moderate to severe pulmonary disease

8. Adrenal or pituitary insufficiency

Healthy Pregnant Women

1. Receiving any hypoglycemic agents

2. Receiving corticosteroids

3. Known kidney, liver, heart, pulmonary, adrenal or pituitary disease

4. Hematocrit < 28%

Neonates

1. Infants that are not viable or too ill for blood sample collection will be included for clinical outcomes data collection, but will be excluded from other research activities.

2. Infants < 1.5 kg will be included for clinical outcomes data collection, but will be excluded from blood sample collection.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Washington

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: collaborator

University of Texas

OTHER

Sponsor Role: collaborator

Indiana University School of Medicine

OTHER

Sponsor Role: collaborator

RTI International

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary F. Hebert, PharmD, FCCP

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Steve Caritis, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Gary DV Hankins, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

David Flockhart, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Indiana University School of Medicine

Indianapolis, Indiana, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

University of Texas Medical Branch

Galveston, Texas, United States

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

820

Identifier Type: -

Identifier Source: org_study_id