Gestational Diabetes Mellitus (GDM)Phase 4NCT07802561
Comparison of Metformin Versus Glyburide for Blood Sugar Control in Women With Gestational Diabetes
A Phase 4 study testing Metformin and Glyburide in people with Gestational Diabetes Mellitus (GDM), run by Nishtar Medical University at 1 site in Pakistan.
Trial summary
The goal of this randomized clinical trial is to compare metformin and glyburide for controlling blood sugar in pregnant women with gestational diabetes mellitus (GDM) who require treatment with oral medication. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM)
- What is being tested?
- Metformin and Glyburide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Apr 2026to 17 Oct 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Gestational diabetes requiring drug treatment
- Gestational age between 13 - 33 weeks based on history and obstetric ultrasonography
Who cannot join
- Known cases of diabetes mellitus
- Serum creatinine > 1.2 mg / dl
- Chronic liver disease
- Hypersensitivity to study medications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Nishtar Medical University and Hospital
Multan, Punjab Province, 60000
Iqra M Principal Investigator, MBBS, +92 306 1324121, iqramahmoodjatoi321@gmail.com
Saima A Professor, FCPS, +92 311 8443876, saimashahzad35177@gmail.com
About this study
Official title: Comparison of Metformin Versus Glyburide in the Control of Gestational Diabetes Mellitus
The goal of this randomized clinical trial is to compare metformin and glyburide for controlling blood sugar in pregnant women with gestational diabetes mellitus (GDM) who require treatment with oral medication.
The main question the study aims to answer is:
Read more
Q: Is treatment failure less common with metformin or glyburide in pregnant women with GDM?
The study will include 92 pregnant women aged 18-45 years with a singleton pregnancy, diagnosed with GDM between 13 and 33 weeks of pregnancy and requiring medication to control blood sugar. Participants will be randomly assigned to one of two treatment groups.
Participants in the metformin group will receive metformin, starting at 850 mg once daily and increased to a maximum of 2,550 mg per day according to their blood sugar levels.
Participants in the glyburide group will receive glyburide, starting at 2.5 mg twice daily and increased according to their blood sugar levels, up to a maximum of 20 mg per day.
Blood glucose levels will be monitored regularly using a glucometer. Treatment will be considered successful when at least 80% of the recorded blood glucose measurements are within the target range. Treatment failure will be defined as fewer than 80% of blood glucose measurements being within the target range after up to 4 weeks of treatment. Participants who have treatment failure or cannot continue the assigned medication because of adverse effects will be switched to insulin therapy.
Participants will be followed during pregnancy until delivery. The study will record treatment failure as the primary outcome and will also assess maternal outcomes, including preeclampsia, polyhydramnios, and preterm delivery, as well as newborn outcomes including macrosomia and the need for admission to a neonatal intensive care unit (NICU).
The study will determine whether metformin or glyburide provides better blood sugar control and reduces the need to switch to insulin in pregnant women with gestational diabetes.
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Being tested
- Metformin, Glyburide
- Keywords
- Gestational DIabetes Mellitus, Glyburide, Glycemic Control, Insulin Therapy, Metformin, Treatment Failure
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage
Starting dose for Metformin will be 850 mg once daily after a meal and/or at 10:00 p.m. The dose will be increased to twice or three times daily according to weekly blood glucose measurements, up to a maximum of 2,550 mg/day. Treatment will continue until delivery.
GlyburideDrug
Starting dose of glyburide will be 2.5 mg twice daily, 30 minutes before meals and/or at 10:00 p.m. The dose will be increased according to weekly blood glucose measurements, up to a maximum of 20 mg/day. Treatment will continue until delivery.
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | Participants will receive metformin orally, once daily Receives: Drug: Metformin |
| Glyburide | Experimental | Participants will receive glyburide orally, twice daily Receives: Drug: Glyburide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Failure
Treatment failure will be defined as fewer than 80% of combined weekly blood glucose measurements being within the target range after treatment initiation. Target glucose levels are pre-prandial <95 mg/dL and post-prandial <140 mg/dL. Participants with treatment failure will be switched to insulin therapy.
Measured: From initiation of oral treatment, up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start18 Apr 2026
- Primary completion17 Oct 2026 (estimated)
- Study completion17 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nishtar Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Iqra Mahmood, Nishtar Medical University
- Investigators
- Saima A Professor, FCPS, Study chair, Nishtar Medical University and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802561
- Sponsor's protocol ID
- U1111-1346-0897
- Status last verified
- Aug 2026
- First submitted
- 30 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Metformin Versus Glyburide in the Control of Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07802561
- Acronym / sponsor ID
- U1111-1346-0897
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Keywords
- Gestational DIabetes Mellitus, Glyburide, Glycemic Control, Insulin Therapy, Metformin, Treatment Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Nishtar Medical UniversityUniversity, hospital or other
- Study start
- 18 Apr 2026 (actual)
- Primary completion
- 17 Oct 2026 (estimated)
- Study completion
- 17 Oct 2026 (estimated)
- First posted
- 3 Sep 2026 (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.
The goal of this randomized clinical trial is to compare metformin and glyburide for controlling blood sugar in pregnant women with gestational diabetes mellitus (GDM) who require treatment with oral medication.
The main question the study aims to answer is:
Q: Is treatment failure less common with metformin or glyburide in pregnant women with GDM?
The study will include 92 pregnant women aged 18-45 years with a singleton pregnancy, diagnosed with GDM between 13 and 33 weeks of pregnancy and requiring medication to control blood sugar. Participants will be randomly assigned to one of two treatment groups.
Participants in the metformin group will receive metformin, starting at 850 mg once daily and increased to a maximum of 2,550 mg per day according to their blood sugar levels.
Participants in the glyburide group will receive glyburide, starting at 2.5 mg twice daily and increased according to their blood sugar levels, up to a maximum of 20 mg per day.
Blood glucose levels will be monitored regularly using a glucometer. Treatment will be considered successful when at least 80% of the recorded blood glucose measurements are within the target range. Treatment failure will be defined as fewer than 80% of blood glucose measurements being within the target range after up to 4 weeks of treatment. Participants who have treatment failure or cannot continue the assigned medication because of adverse effects will be switched to insulin therapy.
Participants will be followed during pregnancy until delivery. The study will record treatment failure as the primary outcome and will also assess maternal outcomes, including preeclampsia, polyhydramnios, and preterm delivery, as well as newborn outcomes including macrosomia and the need for admission to a neonatal intensive care unit (NICU).
The study will determine whether metformin or glyburide provides better blood sugar control and reduces the need to switch to insulin in pregnant women with gestational diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: MetforminParticipants will receive metformin orally, once daily |
| Glyburide | Experimental | Drug: GlyburideParticipants will receive glyburide orally, twice daily |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Gestational diabetes requiring drug treatment
- Gestational age between 13 - 33 weeks based on history and obstetric ultrasonography
Key exclusion criteria (4 listed)
- Known cases of diabetes mellitus
- Serum creatinine > 1.2 mg / dl
- Chronic liver disease
- Hypersensitivity to study medications
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 |
|---|---|---|
| MetforminAlso: GlucophageStarting dose for Metformin will be 850 mg once daily after a meal and/or at 10:00 p.m. The dose will be increased to twice or three times daily according to weekly blood glucose measurements, up to a maximum of 2,550 mg/day. Treatment will continue until delivery. | Drug | Metformin |
| GlyburideStarting dose of glyburide will be 2.5 mg twice daily, 30 minutes before meals and/or at 10:00 p.m. The dose will be increased according to weekly blood glucose measurements, up to a maximum of 20 mg/day. Treatment will continue until delivery. | Drug | Glyburide |
Primary outcome
Treatment Failure
Time frame: From initiation of oral treatment, up to four weeks
Treatment failure will be defined as fewer than 80% of combined weekly blood glucose measurements being within the target range after treatment initiation. Target glucose levels are pre-prandial <95 mg/dL and post-prandial <140 mg/dL. Participants with treatment failure will be switched to insulin therapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- 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.
Saima A Professor, FCPS study chair
Nishtar Medical University and Hospital
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 Metformin and Glyburide in people with Gestational Diabetes Mellitus (GDM), run by Nishtar Medical University at 1 site in Pakistan.
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 2 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: looking for participants now, as of the sponsor's last update on 3 Sep 2026. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iqra M Principal Investigator, MBBS (+92 306 1324121, iqramahmoodjatoi321@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Failure (time frame: From initiation of oral treatment, up to four weeks). 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 3 Sep 2026.