Pregnancy diabetes drugs studied for safety and effectiveness

NCT ID NCT01329016

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 ยท 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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

177 people

The number who actually took part.

Start date

Jul 2011

Finished

Feb 2015

Lead sponsor

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

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Texas Medical Branch

    Galveston, Texas, 77555, United States

  • University of Washington

    Seattle, Washington, 98195, United States

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