Pregnancy diabetes drugs studied for safety and effectiveness
NCT ID NCT01329016
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how the diabetes drugs glyburide and metformin work in pregnant women with gestational diabetes. 177 women between 20 and 32 weeks pregnant took part. The goal was to find the right dose and understand how these drugs control blood sugar and improve insulin function during pregnancy.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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177 people
The number who actually took part.
- Start date
-
Jul 2011
- Finished
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Feb 2015
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
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University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
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University of Texas Medical Branch
Galveston, Texas, 77555, United States
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University of Washington
Seattle, Washington, 98195, United States
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