Overview

This trial is active, not recruiting.

Condition gestational diabetes mellitus
Treatments glyburide, metformin, glyburide-metformin combination
Phase phase 1/phase 2
Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator University of Washington
Start date July 2011
End date May 2015
Trial size 360 participants
Trial identifier NCT01329016, 820

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Women with GDM requiring treatment
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.
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.
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.
(No Intervention)
Non-pregnant women with Type 2 diabetes mellitus who plan to use metformin treatment
(No Intervention)
Healthy pregnant women with normal 1-hour glucose tolerance test

Primary Outcomes

Measure
Study drug dosage in pregnancy
time frame: 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

Measure
Determine GLY and MET PK parameters
time frame: Conclusion of data collection (up to 6 months)

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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.

Additional Information

Official title Glyburide and Metformin for Gestational Diabetes Mellitus
Principal investigator Mary F. Hebert, PharmD, FCCP
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).