Glyburide and Metformin for Gestational Diabetes Mellitus (GDM)
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|
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|
|Indianapolis, IN||Indiana University School of Medicine||no longer recruiting|
|Pittsburgh, PA||University of Pittsburgh||no longer recruiting|
|Galveston, TX||University of Texas Medical Branch||no longer recruiting|
|Seattle, WA||University of Washington||no longer recruiting|
|Intervention model||parallel assignment|
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)
Determine GLY and MET PK parameters
time frame: Conclusion of data collection (up to 6 months)
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.
|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.|
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