Gestational DiabetesEarly Phase 1GGIGNCT02726490
Glyburide vs Glucovance in the Treatment of GDM
A Early Phase 1 study testing Glyburide and Glucovance in people with Gestational Diabetes, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
Trial summary
A randomized comparison of glyburide to glucovance (metformin -glyburide) in the management of diabetes in pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Glyburide and Glucovance
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 14 Aug 2018
- Phase
- Early Phase 1
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gestational diabetes
- Pregnancy > 12 weeks gestation
- Ability to give consent
Who cannot join
- Inability to consent to the study
- Pre-existing diabetes
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Serum creatinine >1
- Liver disease
- Allergy to sulfa;
Show all 9Show fewer
- Allergy to glyburide;
- Allergy to metformin;
- Fetal anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glyburide vs Glucovance in the Treatment of Gestational Diabetes
A randomized comparison of glyburide to glucovance (metformin -glyburide) in the management of diabetes in pregnancy.
Read the detailed description
This study will be a randomized open label trial of glyburide compared to glucovance in the management of gestational diabetes. We hypothesize that glucovance will provide improved glycemic control and a lower failure rate with no increase in neonatal adverse outcomes. Sixty-seven patients will be randomized by computer to each arm of the study. Outcomes will be glycemic control, failure rate of the drug to achieve glycemic goals, and neonatal outcomes.
- Conditions
- Gestational Diabetes
- Being tested
- Glyburide, Glucovance
- Keywords
- gestational diabetes, pregnancy, diabetes
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlyburideDrug
Also called micronase, diabeta, glynase
glyburide 2.5milligrams (mg) at bedtime (qhs) increased as needed to a maximum of 20mg/day usually taken twice a day (BID)
GlucovanceDrug
Also called combination glyburide and metformin
glucovance (2.5/500) 1 taken orally (PO) at bed time (QHS) increased as needed to a maximum dose of (20/2000)/day usually taken twice a day (BID)
| Study group | Role | What they receive |
|---|---|---|
| Glyburide | Active comparator | * Patients will check and record blood glucose fasting and 1 hour after each meal each day. Patients will also keep a diary of all meals.
* The starting dose of glyburide may be 2.5milligrams (mg) to 5mg every day(QD) or twice daily (BID) depending on the degree of hyperglycemia.
* The dose of glyburide will be increased as needed to a maximum of 20mg /day.
* Antenatal testing will be initiated at 28 weeks
* Patients will receive monthly growth scans Receives: Drug: Glyburide |
| Glucovance | Active comparator | * Patients will check and record blood glucose fasting and 1 hour after each meal each day. Patients will also keep a diary of all meals.
* The starting dose of glucovance may be 1.25/250milligrams (mg) either once daily (QD) or twice a day (BID) increased to a maximum of 20mg/2000mg as needed.
* Patients will receive monthly growth scans
* Antenatal testing will be initiated at 28 weeks. Receives: Drug: Glucovance |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of glyburide compared to glucovance
failure rate of glyburide compared to glucovance in ability to achieve euglycemia
Measured: during the index pregnancy
Secondary outcomes (5)
maternal hypoglycemia
the rate of maternal hypoglycemia associated with each drug
Measured: during the index pregnancy
neonatal birthweight
infant weight at birth
Measured: at birth
neonatal apgar scores
infant 1 minute and 5 minute apgar scores
Measured: at birth
neonatal admission to the newborn intensive care unit (NICU)
admission to the Newborn intensive care unit (NICU)
Measured: at birth or within the first 24 hours after birth
neonatal hypoglycemia
failure of the neonate to maintain blood glucose > 60 milligrams/deciliter (mg/dl)
Measured: up to 24 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startJul 2016
- Primary completion14 Aug 2018
- Study completion14 Aug 2018
Why it stopped: Lack of Recruitment
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.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center, El Paso
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa E Moore, MD, Principal investigator, Texas Tech Health Sciences Center El Paso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726490
- Sponsor's protocol ID
- E16008
- Acronym
- GGIG
- Status last verified
- Oct 2020
- First submitted
- 29 Mar 2016
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Moore LE, Briery CM, Clokey D, Martin RW, Williford NJ, Bofill JA, Morrison JC. Metformin and insulin in the management of gestational diabetes mellitus: preliminary results of a comparison. J Reprod Med. 2007 Nov;52(11):1011-5.
PubMed 18161398Moore LE, Clokey D, Rappaport VJ, Curet LB. Metformin compared with glyburide in gestational diabetes: a randomized controlled trial. Obstet Gynecol. 2010 Jan;115(1):55-59. doi: 10.1097/AOG.0b013e3181c52132.
PubMed 20027034
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glyburide vs Glucovance in the Treatment of Gestational Diabetes
- ClinicalTrials.gov ID
- NCT02726490
- Acronym / sponsor ID
- GGIG / E16008
- Conditions
- Gestational Diabetes
- Keywords
- gestational diabetes, pregnancy, diabetes
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Recruitment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences Center, El PasoUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 14 Aug 2018 (actual)
- Study completion
- 14 Aug 2018 (actual)
- First posted
- 1 Apr 2016 (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.
A randomized comparison of glyburide to glucovance (metformin -glyburide) in the management of diabetes in pregnancy.
Detailed description
This study will be a randomized open label trial of glyburide compared to glucovance in the management of gestational diabetes. We hypothesize that glucovance will provide improved glycemic control and a lower failure rate with no increase in neonatal adverse outcomes. Sixty-seven patients will be randomized by computer to each arm of the study. Outcomes will be glycemic control, failure rate of the drug to achieve glycemic goals, and neonatal outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glyburide | Active comparator | Drug: Glyburide* Patients will check and record blood glucose fasting and 1 hour after each meal each day. Patients will also keep a diary of all meals. * The starting dose of glyburide may be 2.5milligrams (mg) to 5mg every day(QD) or twice daily (BID) depending on the degree of hyperglycemia. * The dose of glyburide will be increased as needed to a maximum of 20mg /day. * Antenatal testing will be initiated at 28 weeks * Patients will receive monthly growth scans |
| Glucovance | Active comparator | Drug: Glucovance* Patients will check and record blood glucose fasting and 1 hour after each meal each day. Patients will also keep a diary of all meals. * The starting dose of glucovance may be 1.25/250milligrams (mg) either once daily (QD) or twice a day (BID) increased to a maximum of 20mg/2000mg as needed. * Patients will receive monthly growth scans * Antenatal testing will be initiated at 28 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Gestational diabetes
- Pregnancy > 12 weeks gestation
- Ability to give consent
Key exclusion criteria (9 listed)
- Inability to consent to the study
- Pre-existing diabetes
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Serum creatinine >1
- Liver disease
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 |
|---|---|---|
| GlyburideAlso: micronase, diabeta, glynaseglyburide 2.5milligrams (mg) at bedtime (qhs) increased as needed to a maximum of 20mg/day usually taken twice a day (BID) | Drug | Glyburide |
| GlucovanceAlso: combination glyburide and metforminglucovance (2.5/500) 1 taken orally (PO) at bed time (QHS) increased as needed to a maximum dose of (20/2000)/day usually taken twice a day (BID) | Drug | Glucovance |
Primary outcome
efficacy of glyburide compared to glucovance
Time frame: during the index pregnancy
failure rate of glyburide compared to glucovance in ability to achieve euglycemia
5 secondary outcomes
maternal hypoglycemia
Time frame: during the index pregnancy
neonatal birthweight
Time frame: at birth
neonatal apgar scores
Time frame: at birth
neonatal admission to the newborn intensive care unit (NICU)
Time frame: at birth or within the first 24 hours after birth
neonatal hypoglycemia
Time frame: up to 24 hours after delivery
Results and safety
The study was stopped early (reason given: Lack of Recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Background: PubMed 18161398Moore LE, Briery CM, Clokey D, Martin RW, Williford NJ, Bofill JA, Morrison JC. Metformin and insulin in the management of gestational diabetes mellitus: preliminary results of a comparison. J Reprod Med. 2007 Nov;52(11):1011-5.
- Results publication: PubMed 20027034Moore LE, Clokey D, Rappaport VJ, Curet LB. Metformin compared with glyburide in gestational diabetes: a randomized controlled trial. Obstet Gynecol. 2010 Jan;115(1):55-59. doi: 10.1097/AOG.0b013e3181c52132.
- Individual participant dataSharing planned: No
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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.
Lisa E Moore, MD principal investigator
Texas Tech Health Sciences Center El Paso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Glyburide and Glucovance in people with Gestational Diabetes, run by Texas Tech University Health Sciences Center, El Paso 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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 12 Oct 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 stopped early (reason given: Lack of Recruitment). Results are not available in the source record.
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?
efficacy of glyburide compared to glucovance (time frame: during the index pregnancy). 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 NCT02726490, 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 12 Oct 2020.