Gestational DiabetesPhase 4NCT01947699
Glycemic Profile in Women With Gestational Diabetes Treated With Glyburide
A Phase 4 study testing Glyburide and Continuous glucose monitor in people with Gestational Diabetes, run by University of Pittsburgh at 1 site in United States.
Trial summary
Diabetes is more likely to occur during pregnancy. When present only in pregnancy it is called gestational diabetes, and it places both mom and baby at risk for complications. Glyburide is one of the currently used treatments for diabetes during pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Glyburide and Continuous glucose monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Sep 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women with gestational diabetes
- Singleton gestation
- Receiving glyburide for the treatment gestational diabetes
- Able to give consent
Who cannot join
- Women who require insulin for the treatment of gestational diabetes
- Diagnosis of pregestational diabetes
- Poor glycemic control, > 50% of blood glucose values over 200mg/dl prior to start of the study
- Women receiving medications that affect glycemic control e.g. steroids, within a week of enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Diabetes is more likely to occur during pregnancy. When present only in pregnancy it is called gestational diabetes, and it places both mom and baby at risk for complications. Glyburide is one of the currently used treatments for diabetes during pregnancy. This drug is a medication taken by mouth that decreases sugar levels in the blood. It is known to decrease the risk of complications linked to diabetes in pregnancy. Recent studies in pregnancy have described a difference in the way and how well the drug works compared to when used outside of pregnancy.
Oral blood sugar lowering agents are approved by the Food and Drug Administration (FDA) to lower blood sugar in non-pregnant subjects with diabetes. No oral (taken by mouth) blood-sugar lowering agents are FDA approved for use in pregnancy. Although Glyburide is not FDA approved for this use, it is the most commonly used oral blood sugar lowering agent in pregnancy.
Read more
This research study will help us learn more about the variations in blood sugar levels in women with diabetes in pregnancy who are taking glyburide and how changes in the timing of when the glyburide is taken would affect blood glucose levels. The goals of this study are:
- To find the how glucose changes throughout the day in women with diabetes in pregnancy receiving glyburide
- To learn the effect of changing the time of taking glyburide on glucose levels
- To learn the effect of changing the time between glyburide doses on glucose levels
- To see if insulin is secreted the same throughout the day in response to a morning dose of glyburide.
- Conditions
- Gestational Diabetes
- Being tested
- Glyburide, Continuous glucose monitor
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlyburideDrug
Continuous glucose monitorDevice
| Study group | Role | What they receive |
|---|---|---|
| Glyburide once daily | Experimental | Timing of glyburide dosing will be changed, glucose will be monitored using continuous a glucose monitor. Receives: Drug: Glyburide; Device: Continuous glucose monitor |
| Glyburide twice daily | Experimental | Dose interval and timing of glyburide dose will be changed, glucose will be monitored using continuous a glucose monitor. Receives: Drug: Glyburide; Device: Continuous glucose monitor |
| Mixed meal tolerance test. | Experimental | Subjects will be admitted to the Clinical Translational Research Center, receive a Mixed meal tolerance test and have timed blood draws to assess the effect of glyburide on glucose and insulin metabolism. Receives: Drug: Glyburide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose levels throughout the day
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: PI decided to withdrawal study before recruitment started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maisa Feghali, University of Pittsburgh
- Investigators
- Maisa Feghali, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947699
- Sponsor's protocol ID
- UPMC_GLY_GDM
- Status last verified
- May 2016
- First submitted
- 17 Sep 2013
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hebert MF, Ma X, Naraharisetti SB, Krudys KM, Umans JG, Hankins GD, Caritis SN, Miodovnik M, Mattison DR, Unadkat JD, Kelly EJ, Blough D, Cobelli C, Ahmed MS, Snodgrass WR, Carr DB, Easterling TR, Vicini P; Obstetric-Fetal Pharmacology Research Unit Network. Are we optimizing gestational diabetes treatment with glyburide? The pharmacologic basis for better clinical practice. Clin Pharmacol Ther. 2009 Jun;85(6):607-14. doi: 10.1038/clpt.2009.5. Epub 2009 Mar 18.
PubMed 19295505Caritis SN, Hebert MF. A pharmacologic approach to the use of glyburide in pregnancy. Obstet Gynecol. 2013 Jun;121(6):1309-1312. doi: 10.1097/AOG.0b013e31829007f0.
PubMed 23812467
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Profile in Women With Gestational Diabetes Treated With Glyburide
- ClinicalTrials.gov ID
- NCT01947699
- Acronym / sponsor ID
- UPMC_GLY_GDM
- Conditions
- Gestational Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI decided to withdrawal study before recruitment started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 20 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetes is more likely to occur during pregnancy. When present only in pregnancy it is called gestational diabetes, and it places both mom and baby at risk for complications. Glyburide is one of the currently used treatments for diabetes during pregnancy. This drug is a medication taken by mouth that decreases sugar levels in the blood. It is known to decrease the risk of complications linked to diabetes in pregnancy. Recent studies in pregnancy have described a difference in the way and how well the drug works compared to when used outside of pregnancy.
Oral blood sugar lowering agents are approved by the Food and Drug Administration (FDA) to lower blood sugar in non-pregnant subjects with diabetes. No oral (taken by mouth) blood-sugar lowering agents are FDA approved for use in pregnancy. Although Glyburide is not FDA approved for this use, it is the most commonly used oral blood sugar lowering agent in pregnancy.
This research study will help us learn more about the variations in blood sugar levels in women with diabetes in pregnancy who are taking glyburide and how changes in the timing of when the glyburide is taken would affect blood glucose levels. The goals of this study are:
- To find the how glucose changes throughout the day in women with diabetes in pregnancy receiving glyburide
- To learn the effect of changing the time of taking glyburide on glucose levels
- To learn the effect of changing the time between glyburide doses on glucose levels
- To see if insulin is secreted the same throughout the day in response to a morning dose of glyburide.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glyburide once daily | Experimental | Drug: Glyburide, Device: Continuous glucose monitorTiming of glyburide dosing will be changed, glucose will be monitored using continuous a glucose monitor. |
| Glyburide twice daily | Experimental | Drug: Glyburide, Device: Continuous glucose monitorDose interval and timing of glyburide dose will be changed, glucose will be monitored using continuous a glucose monitor. |
| Mixed meal tolerance test. | Experimental | Drug: GlyburideSubjects will be admitted to the Clinical Translational Research Center, receive a Mixed meal tolerance test and have timed blood draws to assess the effect of glyburide on glucose and insulin metabolism. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women with gestational diabetes
- Singleton gestation
- Receiving glyburide for the treatment gestational diabetes
- Able to give consent
Key exclusion criteria (4 listed)
- Women who require insulin for the treatment of gestational diabetes
- Diagnosis of pregestational diabetes
- Poor glycemic control, > 50% of blood glucose values over 200mg/dl prior to start of the study
- Women receiving medications that affect glycemic control e.g. steroids, within a week of enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glyburide | Drug | Glyburide once daily, Glyburide twice daily, Mixed meal tolerance test. |
| Continuous glucose monitor | Device | Glyburide once daily, Glyburide twice daily |
Primary outcome
Glucose levels throughout the day
Time frame: One week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
- Background: PubMed 19295505Hebert MF, Ma X, Naraharisetti SB, Krudys KM, Umans JG, Hankins GD, Caritis SN, Miodovnik M, Mattison DR, Unadkat JD, Kelly EJ, Blough D, Cobelli C, Ahmed MS, Snodgrass WR, Carr DB, Easterling TR, Vicini P; Obstetric-Fetal Pharmacology Research Unit Network. Are we optimizing gestational diabetes treatment with glyburide? The pharmacologic basis for better clinical practice. Clin Pharmacol Ther. 2009 Jun;85(6):607-14. doi: 10.1038/clpt.2009.5. Epub 2009 Mar 18.
- Background: PubMed 23812467Caritis SN, Hebert MF. A pharmacologic approach to the use of glyburide in pregnancy. Obstet Gynecol. 2013 Jun;121(6):1309-1312. doi: 10.1097/AOG.0b013e31829007f0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maisa Feghali, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glyburide and Continuous glucose monitor in people with Gestational Diabetes, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose levels throughout the day (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01947699, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2016.