Mild Gestational DiabetesPhase 4NCT00744965
Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo
A Phase 4 study testing Glyburide in people with Mild Gestational Diabetes, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This is a randomized prospective trial which addresses the question of whether use of an oral hypoglycemic agent as an adjunct to diet therapy in women with mild gestational diabetes will result in achieving euglycemia in a shorter period of time and, in turn, result in less frequent maternal and neonatal morbidities. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mild Gestational Diabetes
- What is being tested?
- Glyburide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 395 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2008to Jan 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- A glucose value of ≥140 mg/dl on a 50-gram oral glucose loading test by plasma at gestational age between 24 weeks 0 days and 27 weeks 6 days based on clinical information
- An Abnormal 3-hour oral glucose tolerance test with a fasting glucose of ≤105 mg/dl
- Gestational age of less than or equal to 28 weeks and 0 days at the time of consent/randomization
- Singleton gestation
Who cannot join
- Established pregestational diabetes
- Abnormal gestational diabetes testing (≥140) prior to 24 weeks 0 days of gestation. Women who have a negative glucose loading test (<140mg/dl) before 24 weeks may still be considered for this study if they present again for glucose tolerance testing between 24 and 27 weeks.
- Multiple gestations
- Known major fetal anomaly or fetal demise
- Any renal disease with serum creatinine of >1.0
- Known liver disease such as hepatitis
- Maternal or fetal conditions likely to require imminent or very preterm delivery such as preeclampsia, preterm premature rupture of the membranes, preterm labor, and intrauterine fetal growth restriction
- Known hypersensitivity or allergic reaction to Glyburide
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Clinical Trial of Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo
This is a randomized prospective trial which addresses the question of whether use of an oral hypoglycemic agent as an adjunct to diet therapy in women with mild gestational diabetes will result in achieving euglycemia in a shorter period of time and, in turn, result in less frequent maternal and neonatal morbidities. This study is designed to test the hypothesis that in women with mild GDM, use of Glyburide in addition to diet and nutritional counseling lowers mean infant birth weight by 200 grams as compared with diet and nutritional counseling alone.
- Conditions
- Mild Gestational Diabetes
- Being tested
- Glyburide, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlyburideDrug
Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.
PlaceboDrug
Sham dose adjustments of the placebo will be made.
| Study group | Role | What they receive |
|---|---|---|
| Glyburide | Active comparator | Women with mild gestational diabetes will be started ADA diet and a low dose of Glyburide and their medication dosage will be titrated as necessary during the pregnancy to achieve glucose control. Receives: Drug: Glyburide |
| Placebo | Placebo comparator | Women with mild gestational diabetes will be started ADA diet and placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Fetal Weight at Birth
Measured: Immediately after delivery of fetus
Secondary outcomes (10)
Number of Participants With Large for Gestational Age Infants
Birth weight exceeding the 90th percentile for the gestational age at delivery.
Measured: After delivery
Macrosomia
birth weight 4,000 g or greater
Measured: After delivery
Neonatal Intensive Care Unit Admissions
Measured: Until hospital discharge
Rate of Cesarean Delivery
Measured: After delivery
Diagnosis of Pregnancy-induced Hypertension
Measured: until hospital discharge
Shoulder Dystocia
Measured: at delivery
Need for Insulin Treatment
Measured: after delivery
3rd or 4th Degree Perineal Laceration
Measured: at delivery
Chorioamnionitis
Maternal fever >=38.0°C
Measured: intrapartum
Need for Insulin Therapy
Measured: throughout pregnancy and delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2008 (estimated)
- Study start16 Sep 2008
- Primary completionJan 2013
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Leveno, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744965
- Sponsor's protocol ID
- 032011-086
- Other IDs
- 042008-058
- Status last verified
- Mar 2020
- First submitted
- 29 Aug 2008
- Last updated
- 12 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Casey BM, Duryea EL, Abbassi-Ghanavati M, Tudela CM, Shivvers SA, McIntire DD, Leveno KJ. Glyburide in Women With Mild Gestational Diabetes: A Randomized Controlled Trial. Obstet Gynecol. 2015 Aug;126(2):303-309. doi: 10.1097/AOG.0000000000000967.
PubMed 26241419
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial of Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo
- ClinicalTrials.gov ID
- NCT00744965
- Acronym / sponsor ID
- 032011-086
- Conditions
- Mild Gestational Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 395 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 16 Sep 2008 (actual)
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 1 Sep 2008 (estimated)
- Results
- Posted 12 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized prospective trial which addresses the question of whether use of an oral hypoglycemic agent as an adjunct to diet therapy in women with mild gestational diabetes will result in achieving euglycemia in a shorter period of time and, in turn, result in less frequent maternal and neonatal morbidities. This study is designed to test the hypothesis that in women with mild GDM, use of Glyburide in addition to diet and nutritional counseling lowers mean infant birth weight by 200 grams as compared with diet and nutritional counseling alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glyburide | Active comparator | Drug: GlyburideWomen with mild gestational diabetes will be started ADA diet and a low dose of Glyburide and their medication dosage will be titrated as necessary during the pregnancy to achieve glucose control. |
| Placebo | Placebo comparator | Drug: PlaceboWomen with mild gestational diabetes will be started ADA diet and placebo. |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- A glucose value of ≥140 mg/dl on a 50-gram oral glucose loading test by plasma at gestational age between 24 weeks 0 days and 27 weeks 6 days based on clinical information
- An Abnormal 3-hour oral glucose tolerance test with a fasting glucose of ≤105 mg/dl
- Gestational age of less than or equal to 28 weeks and 0 days at the time of consent/randomization
- Singleton gestation
Key exclusion criteria (8 listed)
- Established pregestational diabetes
- Abnormal gestational diabetes testing (≥140) prior to 24 weeks 0 days of gestation. Women who have a negative glucose loading test (<140mg/dl) before 24 weeks may still be considered for this study if they present again for glucose tolerance testing between 24 and 27 weeks.
- Multiple gestations
- Known major fetal anomaly or fetal demise
- Any renal disease with serum creatinine of >1.0
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 |
|---|---|---|
| GlyburideStarting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control. | Drug | Glyburide |
| PlaceboSham dose adjustments of the placebo will be made. | Drug | Placebo |
Primary outcome
Mean Fetal Weight at Birth
Time frame: Immediately after delivery of fetus
10 secondary outcomes
Number of Participants With Large for Gestational Age Infants
Time frame: After delivery
Macrosomia
Time frame: After delivery
Neonatal Intensive Care Unit Admissions
Time frame: Until hospital discharge
Rate of Cesarean Delivery
Time frame: After delivery
Diagnosis of Pregnancy-induced Hypertension
Time frame: until hospital discharge
Shoulder Dystocia
Time frame: at delivery
Need for Insulin Treatment
Time frame: after delivery
3rd or 4th Degree Perineal Laceration
Time frame: at delivery
Chorioamnionitis
Time frame: intrapartum
Need for Insulin Therapy
Time frame: throughout pregnancy and delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26241419Casey BM, Duryea EL, Abbassi-Ghanavati M, Tudela CM, Shivvers SA, McIntire DD, Leveno KJ. Glyburide in Women With Mild Gestational Diabetes: A Randomized Controlled Trial. Obstet Gynecol. 2015 Aug;126(2):303-309. doi: 10.1097/AOG.0000000000000967.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Mild Gestational Diabetes, run by University of Texas Southwestern Medical Center 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 8 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: finished, as of the sponsor's last update on 12 Mar 2020. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 12 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Fetal Weight at Birth (time frame: Immediately after delivery of fetus). 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 NCT00744965, which also lists 1 linked publication.
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 12 Mar 2020.