NCT07802561 Comparison of Metformin Versus Glyburide for Blood Sugar Control in Women With Gestational Diabetes
| NCT ID | NCT07802561 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Nishtar Medical University |
| Condition | Gestational Diabetes Mellitus (GDM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2026-04-18 |
| Primary Completion | 2026-10-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 92 participants in total. It began in 2026-04-18 with a primary completion date of 2026-10-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * Gestational diabetes requiring drug treatment * Gestational age between 13 - 33 weeks based on history and obstetric ultrasonography Exclusion Criteria: * Known cases of diabetes mellitus * Serum creatinine \> 1.2 mg / dl * Chronic liver disease * Hypersensitivity to study medications
Contact & Investigator
Saima A Professor, FCPS
STUDY CHAIR
Nishtar Medical University and Hospital
Frequently Asked Questions
Who can join the NCT07802561 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Gestational Diabetes Mellitus (GDM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07802561 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07802561 currently recruiting?
Yes, NCT07802561 is actively recruiting participants. Contact the research team at iqramahmoodjatoi321@gmail.com for enrollment information.
Where is the NCT07802561 trial being conducted?
This trial is being conducted at Multan, Pakistan.
Who is sponsoring the NCT07802561 clinical trial?
NCT07802561 is sponsored by Nishtar Medical University. The principal investigator is Saima A Professor, FCPS at Nishtar Medical University and Hospital. The trial plans to enroll 92 participants.
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