Glyburide and Metformin for Gestational Diabetes Mellitus (GDM)

United States Department of Health and Human Services (HHS)

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Gestational Diabetes Mellitus

Treatments: Drug: Glyburide-Metformin combination; Drug: Metformin; Drug: Glyburide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01329016

820

Details and patient eligibility

About

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

Full 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.

Enrollment: 360 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 3 patient groups

GDM Subjects

Active Comparator group

Description:

Women with GDM requiring treatment

Treatment:

Drug: Glyburide-Metformin combination

Drug: Metformin

Drug: Glyburide

Non-pregnant Type 2 Diabetes Milletus Subjects

No Intervention group

Description:

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

Healthy Pregnant Women

No Intervention group

Description:

Healthy pregnant women with normal 1-hour glucose tolerance test