Gestational Diabetes Mellitus, Class A2Phase 4GLAMNCT03078725
Failure Rate of GLyburide And Metformin Among Gestational Diabetics
A Phase 4 study testing Glyburide and Metformin in people with Gestational Diabetes Mellitus, Class A2, run by The University of Texas Health Science Center, Houston.
Trial summary
A pragmatic, comparative effectiveness trial of glyburide versus metformin. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus, Class A2
- What is being tested?
- Glyburide and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2017to 10 May 2018
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- We will include women between 20 and 34 weeks gestational age, with a diagnosis of GDM as per the following criteria:
- 1 hour Glucose tolerance test of >130 mg/dl, followed by two abnormal values on 3 hour Glucose tolerance test, or:
- A single 1 hour Glucose tolerance test value of > 200 mg/dl, and:
- Failure to achieve glycemic control with diet and exercise or deemed to require pharmacological therapy as per physician's criteria
Who cannot join
- - Known renal impairment.
- Known hepatic disease.
- Pre-gestational diabetes.
- Known allergy to glyburide, metformin or sulfa drugs.
About this study
A pragmatic, comparative effectiveness trial of glyburide versus metformin.
Read the detailed description
Patients with gestational diabetes requiring pharmaceutical treatment will be randomized to receive glyburide or metformin. Dose increases will be determined by the patient's physician. Patients will be determined to have failed either medication if glucose control can not be achieved with the maximum dose of the medication, if insulin is stared to achieve glucose control or if another oral agent is started along for glucose control.
- Conditions
- Gestational Diabetes Mellitus, Class A2
- Being tested
- Glyburide, Metformin
- Keywords
- gestational diabetes, glyburide, metformin, failure rate
- 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
oral hypoglycemic agent
MetforminDrug
oral hypoglycemic agent
| Study group | Role | What they receive |
|---|---|---|
| Glyburide | Active comparator | hypoglycemic agent approved for treatment of GDMA2 Receives: Drug: Glyburide |
| Metformin | Active comparator | hypoglycemic agent approved for treatment of GDMA2 Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure rate
need to start insulin therapy or another hypoglycemic agent during the pregnancy to maintain normal glucose levels or need for delivery due to hyperglycemia.
Measured: from onset of oral therapy until delivery
Secondary outcomes (9)
Mean overall plasma glucose
average of all postprandial glucose measurements
Measured: from enrollment to delivery
Mean weekly fasting glucose
average of all fasting glucose measurements
Measured: from enrollment to delivery
preeclampsia
preeclampsia
Measured: from enrollment to delivery
cesarean section
mode of delivery
Measured: from enrollment to delivery
neonatal hypoglycemia
neonatal hypoglycemia
Measured: from enrollment to delivery
LGA infant
LGA infant
Measured: from enrollment to delivery
birthweight > 4500 grams
birthweight > 4500 grams
Measured: from enrollment to deliveryfrom enrollment to delivery
gestational age at birth
gestational age at birth
Measured: from enrollment to delivery
incidence of medication side effects
nausea, emesis, diarrhea, abdomainal bloating
Measured: from enrollment to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start20 Jun 2017 (estimated)
- Primary completion10 Mar 2018 (estimated)
- Study completion10 May 2018 (estimated)
Why it stopped: Research was competing with other projects in the department, and no patients were recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus, Class A2Studies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Model description
- patients will be randomized to two groups, one receiving glyburide and one receiving metformin.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenifer Dinis Ballestas, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078725
- Sponsor's protocol ID
- HSC-MS-16-1052
- Acronym
- GLAM
- Status last verified
- May 2018
- First submitted
- 7 Mar 2017
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Failure Rate of GLyburide And Metformin Among Gestational Diabetics
- ClinicalTrials.gov ID
- NCT03078725
- Acronym / sponsor ID
- GLAM / HSC-MS-16-1052
- Conditions
- Gestational Diabetes Mellitus, Class A2
- Keywords
- gestational diabetes, glyburide, metformin, failure rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Research was competing with other projects in the department, and no patients were recruited.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 20 Jun 2017 (estimated)
- Primary completion
- 10 Mar 2018 (estimated)
- Study completion
- 10 May 2018 (estimated)
- First posted
- 13 Mar 2017 (actual)
- 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 pragmatic, comparative effectiveness trial of glyburide versus metformin.
Detailed description
Patients with gestational diabetes requiring pharmaceutical treatment will be randomized to receive glyburide or metformin. Dose increases will be determined by the patient's physician. Patients will be determined to have failed either medication if glucose control can not be achieved with the maximum dose of the medication, if insulin is stared to achieve glucose control or if another oral agent is started along for glucose control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- patients will be randomized to two groups, one receiving glyburide and one receiving metformin.
| Arm | Type | Receives |
|---|---|---|
| Glyburide | Active comparator | Drug: Glyburidehypoglycemic agent approved for treatment of GDMA2 |
| Metformin | Active comparator | Drug: Metforminhypoglycemic agent approved for treatment of GDMA2 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- We will include women between 20 and 34 weeks gestational age, with a diagnosis of GDM as per the following criteria:
- 1 hour Glucose tolerance test of >130 mg/dl, followed by two abnormal values on 3 hour Glucose tolerance test, or:
- A single 1 hour Glucose tolerance test value of > 200 mg/dl, and:
- Failure to achieve glycemic control with diet and exercise or deemed to require pharmacological therapy as per physician's criteria
Key exclusion criteria (4 listed)
- - Known renal impairment.
- Known hepatic disease.
- Pre-gestational diabetes.
- Known allergy to glyburide, metformin or sulfa drugs.
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 |
|---|---|---|
| Glyburideoral hypoglycemic agent | Drug | Glyburide |
| Metforminoral hypoglycemic agent | Drug | Metformin |
Primary outcome
Failure rate
Time frame: from onset of oral therapy until delivery
need to start insulin therapy or another hypoglycemic agent during the pregnancy to maintain normal glucose levels or need for delivery due to hyperglycemia.
9 secondary outcomes
Mean overall plasma glucose
Time frame: from enrollment to delivery
Mean weekly fasting glucose
Time frame: from enrollment to delivery
preeclampsia
Time frame: from enrollment to delivery
cesarean section
Time frame: from enrollment to delivery
neonatal hypoglycemia
Time frame: from enrollment to delivery
LGA infant
Time frame: from enrollment to delivery
birthweight > 4500 grams
Time frame: from enrollment to deliveryfrom enrollment to delivery
gestational age at birth
Time frame: from enrollment to delivery
incidence of medication side effects
Time frame: from enrollment to delivery
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 4 May 2018.
- Individual participant dataSharing planned: No
Related trials for Gestational Diabetes Mellitus, Class A2
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glyburide and Metformin in people with Gestational Diabetes Mellitus, Class A2, run by The University of Texas Health Science Center, Houston.
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 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Failure rate (time frame: from onset of oral therapy until delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2018.